Janet Pinelli1, Amanda J Symington2
Background - Methods - Results - Characteristics of Included Studies - References - Data Tables and Graphs
1School of Nursing, McMaster University, Hamilton, Canada
2The Children's Hospital, Hamilton Health Sciences, Hamilton, Ontario, Canada
Citation example: Pinelli J, Symington AJ. Non-nutritive sucking for promoting physiologic stability and nutrition in preterm infants. Cochrane Database of Systematic Reviews 2005, Issue 4. Art. No.: CD001071. DOI: 10.1002/14651858.CD001071.pub2.
School of Nursing
McMaster University
1200 Main St. West
Hamilton Ontario L8N 3Z5
Canada
E-mail: pinellij@mcmaster.ca
| Assessed as Up-to-date: | 06 April 2010 |
|---|---|
| Date of Search: | 16 March 2010 |
| Next Stage Expected: | 06 April 2012 |
| Protocol First Published: | Issue 2, 1998 |
| Review First Published: | Issue 3, 1998 |
| Last Citation Issue: | Issue 4, 2005 |
| Date / Event | Description |
|---|---|
| 06 April 2010 Updated | This review updates the review "Non-nutritive sucking for promoting physiologic stability and nutrition in preterm infants" published in the Cochrane Database of Systematic Reviews (Pinelli 2005). Updated search found no new trials. No changes to conclusions. |
| Date / Event | Description |
|---|---|
| 28 October 2008 Amended | Converted to new review format. |
| 14 July 2005 New citation: conclusions not changed | Substantive amendment |
| 14 July 2005 Updated | This review updates the existing review of "Non-nutritive sucking for promoting physiologic stability and nutrition in preterm infants" which was published in The Cochrane Library, Issue 3, 2003 (Pinelli 2003). |
Non-nutritive sucking is used during gavage feeding and in the transition from gavage to breast/bottle feeding in preterm infants to promote the development of sucking behaviour and improve digestion of enteral feedings.
To determine whether non-nutritive sucking (NNS) in preterm infants influences: a) weight gain, b) energy intake, c) heart rate, d) oxygen saturation, e) length of hospital stay, f) intestinal transit time, g) age at full oral feeds, or h) any other clinically relevant outcomes.
MEDLINE and CINAHL databases back to 1976 and the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2005) were searched.
Updated search in March 2010 included MEDLINE (search via PubMed), CINAHL, EMBASE and CENTRAL (The Cochrane Library).
All trials utilizing experimental or quasi-experimental designs in which non-nutritive sucking in preterm infants was compared to no provision of non-nutritive sucking were eligible for the review.
Data were extracted independently by the two authors. No subgroup analyses were performed because of the small number of studies related to the relevant outcomes.
This review consisted of 21 studies, 15 of which were randomized controlled trials. NNS was found to decrease significantly the length of hospital stay in preterm infants. The review did not reveal a consistent benefit of NNS with respect to other major clinical variables (weight gain, energy intake, heart rate, oxygen saturation, intestinal transit time, age at full oral feeds and behavioral state). The review identified other positive clinical outcomes of NNS: transition from tube to bottle feeds and better bottle feeding performance. No negative outcomes were reported in any of the studies.
This review found a significant decrease in length of stay in preterm infants receiving a NNS intervention. The review did not reveal a consistent benefit of NNS with respect to other major clinical variables (weight gain, energy intake, heart rate, oxygen saturation, intestinal transit time, age at full oral feeds and behavioral state).
The review identified other positive clinical outcomes of NNS: transition from tube to bottle feeds and better bottle feeding performance. No negative outcomes were reported in any of the studies. There were also a number of limitations of the presently available evidence related to the design of the studies, outcome variability, and lack of long-term data. Based on the available evidence, NNS in preterm infants would appear to have some clinical benefit. It does not appear to have any short-term negative effects.
An infant born prematurely may be fed through a tube into the stomach, so is often given a pacifier to suck on to improve nutrition. An infant needs coordinated sucking, swallowing and breathing to feed. The ability to suck and to swallow is present by 28 weeks gestation, but infants are not fully coordinated until 32 to 34 weeks. This means that preterm infants less than 32 weeks gestation are usually not able to feed effectively from the breast or a bottle. They are fed by a small tube that is placed up the nose into the stomach (gavage feeding). Sucking on a pacifier (non-nutritive sucking) during gavage feeding may encourage the development of sucking behaviour and improve digestion of the feeding. Non-nutritive sucking may also have a calming effect on infants, although it does have the potential to interfere with breastfeeding. The authors searched the medical literature and found 21 studies, 15 were randomized controlled trials and six were non-randomized. The total number of infants in each study ranged from 10 to 59. Weight gain was similar with and without use of a pacifier. Preterm infants with pacifiers did not stay in hospital as long as those without and hospital costs were less (two studies). These infants showed less defensive behaviors during tube feedings, spent less time in fussy and active states during and after tube feedings, and settled more quickly into sleep. Their transition to full enteral (by tube or mouth) or bottle feeds (three studies) and bottle feeding performance, in general, (one study) were easier. No negative outcomes were reported.
The early components of sucking have been demonstrated to occur in fetal life from about seven to eight weeks post-conceptual age. Oral and gag reflexes appear at about 12 to 16 weeks and sucking at 24 weeks. Sucking and swallowing are present by 28 weeks, although not fully coordinated until about 32 to 34 weeks (Goldson 1987).
The development of sucking behaviours in preterm infants is thought to reflect neurobehavioural maturation and organization. From a clinical perspective, the ability to feed depends upon a coordinated sucking, swallowing and breathing pattern. In preterm infants less than 32 weeks gestation, this ability is not usually effective enough to sustain full oral feeds. In the interim, infants are fed by gavage tube until they are mature enough to take milk directly from the breast or bottle.
Non-nutritive sucking has been used during gavage feeding and in the transition from gavage to breast/bottle feeding.
The rationale for this intervention is that non-nutritive sucking facilitates the development of sucking behaviour and improves digestion of enteral feeds. A number of enzymes/hormones have been implicated in the facilitation of digestion through non-nutritive sucking; lingual lipase, gastrin, insulin and motilin. Non-nutritive sucking is thought to stimulate the secretion of these enzymes/hormones through vagal innervation in the oral mucosa (Hamosh 1979; Chey 1980; Wiener 1987). In addition, non-nutritive sucking is believed to have a calming effect on infants and is commonly used as an intervention in nurseries and neonatal intensive care units (Kimble, 1992). Non-nutritive sucking has been considered to be a benign intervention, although it has the potential to have a negative effect on breastfeeding or on the incidence of later oral aversion.
Non-nutritive sucking is organized in a stable temporal pattern whose features can be analyzed by quantitative techniques (Wolff 1972). Non-nutritive sucking has been studied using quasi-experimental and experimental designs for its effect on neonates with respect to a number of clinical outcomes.
Schwartz 1987 synthesized five studies of non-nutritive sucking in preterm infants in a meta-analysis. The authors concluded that non-nutritive sucking reduced the time to first bottle feeding and reduced the days of hospitalization. Outcome data related to weight gain were inconclusive.
A meta-analysis of the non-nutritive sucking research in preterm infants by Steer, Lucas and Sinclair (Steer 1992) included eight randomized trials. The major outcome variables studied in these trials included weight gain, gastrointestinal transit, readiness for nipple feedings and length of hospitalization. A lack of blinding to the intervention and/or outcome measurement in all studies affected the methodologic quality of the findings. The authors concluded that in view of the limitations in the available research, there was insufficient beneficial evidence to support the use of non-nutritive sucking in the management of tube-fed preterm infants.
The review of literature demonstrates the need for the continued synthesis of available evidence to support the on-going use of non-nutritive sucking interventions in neonatal care.
The objectives of this review are to examine the evidence for the beneficial or adverse effects of non-nutritive sucking in preterm infants by:
i) identifying all experimental and quasi-experimental trials of non-nutritive sucking in preterm infants;
ii) assessing the methodologic quality of each study;
iii) estimating overall effects of non-nutritive sucking on clinically relevant outcomes such as:
All experimental and quasi-experimental studies in which non-nutritive sucking in preterm infants was compared to no provision of non-nutritive sucking were identified.
All infants born at < 37 weeks post-conceptual age. Studies involving both preterm and term (greater than or equal to 37 weeks) were excluded.
Computerized searches were conducted by both reviewers. MEDLINE and CINAHL databases back to 1976 and the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 1, 2005) were searched using the following MeSH headings: infant, premature; intensive care units, neonatal; enteral nutrition; sucking behaviour; infant nutrition; gastric emptying; growth; parenteral nutrition; bottle feeding; infant care; infant, low birth weight; somatostatin; crying; oxygen; child development; physical stimulation; taste; infant, newborn; feeding behaviour. These headings were chosen from the articles in the meta-analysis by Steer et al (Steer 1992). The following text words were also searched: non(tw) and nutritive(tw) and suck(tw). Trials evaluating the effect of NNS on pain in the preterm infant were excluded.
In March 2010, we updated the search as follows: MEDLINE (search via PubMed), CINAHL, EMBASE and CENTRAL (The Cochrane Library) were searched from 2005 to 2010. Search terms: "intensive care unit" OR "enteral nutrition" OR "sucking behaviour" OR nutrition OR "gastric emptying" OR growth OR "parenteral nutrition" OR "bottle feeding" OR somatostatin OR crying OR "child development" OR "physical stimulation" OR "feeding behaviour. Limits: human, newborn infant and clinical trial. No language restrictions were applied.
All potentially relevant titles and abstracts identified by either reviewer were retrieved. The reference lists/bibliographies of each article were reviewed independently for additional relevant titles and these were also retrieved. The list of all relevant articles was sent to two major authors in this area. They were asked if they knew of any other published or unpublished studies relevant to the area that have not been included in the original list.
The systematic review followed the methods described in the Cochrane Collaboration Handbook and by the Cochrane Neonatal Review Group.
All of the articles that were retrieved from the complete search were assessed for relevance independently by the two review authors. Criteria for relevance included trials that utilized: experimental or quasi-experimental designs, intervention of non-nutritive sucking in preterm infants, and clinically relevant outcomes. The articles that met all relevance criteria were assessed for methodological quality based on the criteria stated in the section below. A kappa statistic was calculated on the agreement between both review authors at two stages in the review process: in the assessment of relevance of the articles and in the assessment of the methodologic quality of the relevant articles. For relevance of the articles, the kappa was 0.62, with 87% agreement. For methodologic quality the kappa was 0.61, with 82% agreement. Differences were resolved through discussion and were mainly related to oversights on the part of one of the readers.
Those articles judged to have the appropriate quality by both review authors were included in the analysis.
Data were extracted independently by the two review authors. Missing data were obtained from the original authors where possible. The study by Yu 1999 was assessed by only one review author because of the language limitation.
The standard methods of the Cochrane Neonatal Review Group were employed. The methodological quality of the studies were assessed using the following key criteria: allocation concealment (blinding of randomization), blinding of intervention, completeness of follow-up, and blinding of outcome measurement/assessment. For each criterion, assessment was yes, no, can't tell. Two review authors separately assessed each study. Any disagreement was resolved by discussion. This information was added to the table Characteristics of Included Studies.
In addition, at the time of the update in 2010, the following issues were evaluated and entered into the Risk of Bias Table:
1) Sequence generation (checking for possible selection bias). Was the allocation sequence adequately generated?
For each included study, we categorized the method used to generate the allocation sequence as:
- adequate (any truly random process e.g. random number table; computer random number generator);
- inadequate (any non random process e.g. odd or even date of birth; hospital or clinic record number);
- unclear.
(2) Allocation concealment (checking for possible selection bias). Was allocation adequately concealed?
For each included study, we categorized the method used to conceal the allocation sequence as:
- adequate (e.g. telephone or central randomization; consecutively numbered sealed opaque envelopes);
- inadequate (open random allocation; unsealed or non-opaque envelopes, alternation; date of birth);
- unclear.
(3) Blinding (checking for possible performance bias). Was knowledge of the allocated intervention adequately prevented during the study? At study entry? At the time of outcome assessment?
For each included study, we categorized the methods used to blind study participants and personnel from knowledge of which intervention a participant received. Blinding was assessed separately for different outcomes or classes of outcomes. We categorized the methods as:
- adequate, inadequate or unclear for participants;
- adequate, inadequate or unclear for personnel;
- adequate, inadequate or unclear for outcome assessors.
In some situations there may be partial blinding e.g. where outcomes are self-reported by unblinded participants but they are recorded by blinded personnel without knowledge of group assignment. Where needed “partial” was added to the list of options for assessing quality of blinding.
(4) Incomplete outcome data (checking for possible attrition bias through withdrawals, dropouts, protocol deviations). Were incomplete outcome data adequately addressed?
For each included study and for each outcome, we described the completeness of data including attrition and exclusions from the analysis. We noted whether attrition and exclusions were reported, the numbers included in the analysis at each stage (compared with the total randomized participants), reasons for attrition or exclusion where reported, and whether missing data were balanced across groups or were related to outcomes. Where sufficient information was reported or supplied by the trial authors, we re-included missing data in the analyses. We categorized the methods as:
- adequate (< 20% missing data);
- inadequate (≥ 20% missing data):
- unclear.
(5) Selective reporting bias. Are reports of the study free of suggestion of selective outcome reporting?
For each included study, we described how we investigated the possibility of selective outcome reporting bias and what we found. We assessed the methods as:
- adequate (where it is clear that all of the study’s pre-specified outcomes and all expected outcomes of interest to the review have been reported);
- inadequate (where not all the study’s pre-specified outcomes have been reported; one or more reported primary outcomes were not pre-specified; outcomes of interest are reported incompletely and so cannot be used; study fails to include results of a key outcome that would have been expected to have been reported);
- unclear.
(6) Other sources of bias. Was the study apparently free of other problems that could put it at a high risk of bias?
For each included study, we described any important concerns we had about other possible sources of bias (for example, whether there was a potential source of bias related to the specific study design or whether the trial was stopped early due to some data-dependent process). We assessed whether each study was free of other problems that could put it at risk of bias as:
- yes; no; or unclear.
If needed, we planned to explore the impact of the level of bias through undertaking sensitivity analyses.
Statistical analyses were performed using Review Manager software. Categorical data were analyzed using relative risk (RR), risk difference (RD) and the number needed to treat (NNT). Continuous data were analyzed using weighted mean difference (WMD). The 95% Confidence interval (CI) was reported on all estimates.
We estimated the treatment effects of individual trials and examined heterogeneity between trials by inspecting the forest plots and quantifying the impact of heterogeneity using the I2 statistic. If we detected statistical heterogeneity, we explored the possible causes (for example, differences in study quality, participants, intervention regimens, or outcome assessments) using post hoc subgroup analyses.
Meta-analysis was performed using Review Manager software (RevMan 5) supplied by the Cochrane Collaboration. For estimates of typical relative risk and risk difference, we used the Mantel-Haenszel method. For measured quantities, we used the inverse variance method. All meta-analyses were done using the fixed effect model.
All of the 21 studies that met the relevance criteria were included in the review. It should be noted that none of the 21 studies met all of the methodologic quality criteria. Of the 21 studies, 15 were randomized controlled trials and six utilized non-randomized designs. The total sample sizes in the studies ranged from 10 to 59 infants. The intervention of non-nutritive sucking was delivered through the use of a pacifier and occurred during gavage feeding, before and/or after bottle feeding, or not related to feeding. A large number of outcomes were utilized in the 21 studies but only a few were common among them. The overall review includes both randomized and non-randomized studies, although only randomized studies are included in the data analysis. Details of each included study are in the table, Characteristics of Included Studies.
Thirteen studies were excluded from the review. The reason for exclusion in all cases was because they did not meet one or more of the relevance criteria (see Characteristics of Excluded Studies). The relevance of the studies in these cases could not be determined by the title or abstract and required a review of the entire article.
The included (and excluded) studies were assessed using the following key criteria: blindness of randomization, blindness of intervention, complete follow-up and blinding of outcome measurement. Additional criteria of study quality included: evidence of co-intervention, objective criteria of measuring outcomes and defined exclusion/inclusion criteria. The non-nutritive sucking intervention cannot be blind to those providing care, but should be blind to the assessors of the outcomes. Of the 15 RCTs, eight utilized a cross-over design where the infants served as their own controls. These studies were not included in the meta-analysis, but were included in the results. Blindness of randomization was evident in only six of the studies. In only one study was it clear that the outcome assessors were blinded. Complete follow-up occurred in all of the studies.
This review consisted of 21 studies, 15 of which were randomized controlled trials. The data analysis involved seven clinical outcomes, although only four included more than one study in the outcome category. The results of the tests of heterogeneity of the analyses utilizing more than one study were significant for only one outcome, heart rate. The analyses of the studies for the remaining three outcomes were all non-significant for heterogeneity.
The first of those four outcomes is weight gain in grams per day. Three randomized trials were included in the meta-analysis. Two of the trials showed no difference between groups during a two-week study period (Ernst 1989; Mattes 1996). The third trial demonstrated a trend favouring the control group, although the time of data collection is not specified (Field 1982). The overall effect was non-significant (WMD 1.57 g/day, 95% CI -0.37,3.50). A fourth randomized trial, Bernbaum (1983), demonstrated a significant difference in weight gain favouring the treatment group by the second week and the difference remained significant throughout the study period (six weeks). This study was not included in the meta-analysis because the standard deviations were unavailable from the authors. In addition, two non-randomized studies utilized weight gain as an outcome. Both studies showed no difference in weight gain between the treatment and control groups (Measel 1979; Sehgal 1990). Based on the results of the randomized and non-randomized studies, there is no clear benefit of NNS with respect to weight gain in grams per day.
Heart rate was measured in four randomized trials. Neither study by Pickler (Pickler 1993; Pickler 1996) showed a difference between groups. One study by McCain (1995) also demonstrated no difference but her earlier study showed a difference in favour of the treatment group (McCain 1992). Although statistically significant, the difference in heart rate was not clinically significant. The overall effect of the analysis, however, showed no statistically significant difference between groups (WMD -1.4 beats/min, 95% CI -5.9, 3.1). It should be noted that this analysis was significant for heterogeneity so the results must be viewed with caution.
Three randomized trials measured oxygen saturation as an effect of NNS. None of the individual trials showed a significant difference between groups, but the overall effect approached significance in favour of the control group (WMD 1.0 %, 95% CI -0.04, 2.1). As with heart rate, the differences were not clinically significant.
Two randomized trials examined the effect of NNS on length of hospital stay (in days). Field (1982) found no difference between groups, while Bernbaum (1983) demonstrated a significant reduction in length of stay. The overall analysis did reveal a significant difference in length of hospital stay (WMD -7.1 days, CI -12.6, -1.7). Although Field (1982) did not demonstrate a significant difference in length of hospital stay, she did report a positive economic impact of NNS on hospital costs.
There are a number of outcomes associated with NNS that have been reported in single studies. Three of these studies have been included in the table of comparisons because of their clinical relevance and because they are randomized trials. DeCurtis 1986 found no significant difference between experimental and control groups with respect to intestinal transit time (in hours) or energy intake (kcal/kg/day). In contrast, another randomized study by Bernbaum 1983 showed a significantly increased transit time in infants receiving NNS by the end of the first week and persisted throughout the remaining four weeks. This study was not included in the meta-analysis because the standard deviations were unavailable from the authors. Mattes 1996 showed no difference in post-conceptual age at full oral feeds (in days).
Ernst 1989 studied the effect of NNS on energy balance and DeCurtis 1986 studied nutrient retention. Both studies were done in tube fed babies. Ernst (1989) found NNS to have no effect on energy expenditure, stool excretion or stool fat. DeCurtis (1986) reported that NNS had no effect on stool energy and stool fat. Three randomized trials reported no effect of NNS on gastric emptying (Ernst 1989; Szabo 1985; Widstrom 1988). No data were available for these trials so that a meta-analysis was not possible.
Widstrom 1988 and Kanarek 1992 studied the effect of NNS on specific hormones in tube fed infants. Kanarak 1992 found that NNS has no apparent effect on the blood concentrations of motilin, gastrin, insulin or insulin-like growth factor 1, three days after commencing feeds. Widstrom 1988 reported a significant decrease in somatostatin levels with NNS.
DiPietro 1994 reported the effect of NNS on physiological parameters in tube fed infants. She found NNS to have no effect on vagal tone, oxygen saturation and heart rate. However, Burroughs 1978 did report a significant improvement in TcPO2 readings in the infants receiving NNS that was not associated with feeding.
The effect of NNS on the transition from tube feeds to bottle feeds has been reported by Field 1982 and Sehgal 1990. Field 1982 found that infants offered NNS had significantly fewer days of tube feeding (three-day difference). Sehgal 1990 reported that the time for transition from tube feeds to bottle feeds was significantly reduced by 1.6 days in infants receiving NNS. Widstrom 1988 also reported a significant decrease in tube feeding time in infants receiving NNS. Yu 1999 found that feeding performance was improved in the NNS group. With NNS there was significantly more intake within the first five minutes, more total amount of feeding, less feeding time and a faster feeding rate. Pickler 2004 found no statistically significant effect of NNS on the amount of formula consumed per minute of feeding.
DiPietro 1994 and Field 1982 both analyzed the effect of NNS on behavioral state during tube feedings. The data, however, cannot be combined as the authors used different measurement scales. DiPietro 1994 used Anderson's 12-level Behavioral State Scale (ABSS) and found that infants receiving NNS spent significantly less time in fussy and active awake states during and after a tube feed, and settle more quickly into a sleep state. Field 1982 used the Brazelton Neonatal Behavioral Assessment Scale (NBAS) and found that NNS had no effect on behavioral state. DiPietro 1994 found that infants receiving NNS exhibited less defensive behaviors during tube feeding. Yu 1999 found that preterm infants receiving NNS before bottle feeding spent significantly more time in a quiet awake state and less time in active sleep, drowsiness, active awake and crying states. Three and five minutes of NNS showed the same effect on behavioral states and feeding. Pickler 2004 analyzed the effect of NNS on behavioral state before, during and after bottle feeding and demonstrated no effect on behavioral state.
In summary, the results of this review demonstrated a significant effect on the length of hospital stay favouring the experimental group. Several studies also demonstrated a positive effect from NNS on: decreased somatostatin levels; increased TcPO2 readings; decreased time to establish nipple feeds; better bottle feeding performance; decreased time in fussy and awake states; settled more quickly following feeds; and exhibited less defensive behaviors during tube feeding. The results of this review revealed no significant effect of NNS on: weight gain; energy intake; heart rate; oxygen saturation; intestinal transit time; time to full oral feeds; energy expenditure; stool excretion or stool fat; stool energy; gastric aspirates; blood concentrations of motilin, gastrin, insulin or insulin-like growth factor-1; vagal tone; or behavioral state.
The results of this review demonstrated a significant benefit of NNS on length of hospital stay (in days). The review did not reveal a benefit of NNS with respect to the other major clinical variables (weight gain, energy intake, heart rate, oxygen saturation, intestinal transit time, and post-conceptual age at full oral feeds).
The review identified other positive clinical outcomes of NNS: transition from tube to bottle feeds, better bottle feeding performance. No negative outcomes were reported in any of the studies. There were a number of limitations of the presently available evidence:
1. Design Limitations
Although 15 of the 21 studies reviewed were randomized trials, eight were cross-over designs. Cross-over designs present at least two limitations in assessing the effects of non-nutritive sucking. The appropriate length of time to wash out the effects of the NNS intervention prior to crossover is not known; and late effects, e.g. time to full feeding, cannot be assessed. In only six trials was the randomization clearly blinded. Because of the nature of the intervention, blinding was not possible. However, blinding of outcome assessors, although possible was evident in only one of the studies reviewed.
2. Outcome Variability
Meta-analysis was limited in this review due to the large variation in outcomes and limited number of randomized trials that were included in each outcome. Although many of the studies measured similar outcomes, the outcomes were too dissimilar to be included in a meta-analysis. Alternatively, the authors reported the significance level but no specific data were provided. In addition, the context of the measurement of the outcomes varied greatly among studies. For example, outcomes were measured before, during or after gavage feeding; before or after bottle feeding; or not associated with feeding. Because of the small number of studies in each category that measured comparable outcomes, all studies were combined regardless of context. These contextual differences should be noted when considering the results of the review.
3. Lack of long-term data
The studies reviewed included no short- or long-term negative outcomes. The outcomes chosen were either found to have a positive short-term effect or no effect as a result of NNS. Examples of potential negative effects would be the effect of NNS on breastfeeding or on incidence of later oral aversion. The negative impact of NNS was not measured in any of the studies. None of the infants in the studies reviewed were followed past hospital discharge.
NNS demonstrated a benefit in only one of the major outcomes measured. There were also a number of short-term positive results for several of the secondary outcomes. No negative effects of NNS were studied, however.
The main results of the meta-analysis, and from the single and non-randomized studies indicate that NNS decreases length of hospital stay in preterm infants, and appears to facilitate the transition to full oral/bottle feeds and bottle feeding performance in general. Infants receiving NNS exhibited less defensive behaviors during tube feedings, spent significantly less time in fussy and active states during and after tube feedings, and settled more quickly into sleep states. Positive effects of NNS on behavioral state were not consistently demonstrated.
Although a number of outcomes demonstrated no difference with or without NNS, there do not appear to be any short-term negative effects as a result of this intervention. Based on the available evidence, NNS in preterm infants would appear to have some clinical benefit. Although not specifically studied, NNS does not appear to have any negative effect, short-term. No long-term data on the effects of NNS are presently available.
In view of the fact that there are no long-term data, further investigations are recommended. In order to facilitate meta-analysis of these data, future research in this area should involve outcome measures consistent with those used in previous studies. In addition, published reports should include all relevant data.
We would like to thank Patricia Austin for her assistance in retrieval of the references for this review.
The Cochrane Neonatal Review Group has been funded in part with Federal funds from the Eunice Kennedy Shriver National Institute of Child Health and Human Development National Institutes of Health, Department of Health and Human Services, USA, under Contract No. HHSN267200603418C.
Janet Pinelli (JP) and Amanda J Symington (AS) wrote the original review and updated the review in 2001, 2003 and 2005.
The April 2010 update was conducted centrally by the Cochrane Neonatal Review Group staff (Yolanda Montagne, Diane Haughton, and Roger Soll). This update was reviewed and approved by JP.
| Methods | Randomized |
|---|---|
| Participants | Appropriate for gestational age |
| Interventions | Experimental group: Pacifier during tube feed only |
| Outcomes | Weight, length, head circumference |
| Notes | Random envelope assignment (information supplied by author) |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized |
| Allocation concealment? | Yes | Blinding of randomization - Yes |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Pretest-posttest design |
|---|---|
| Participants | Gestational age < 37 weeks |
| Interventions | No sucking (pretreatment), pacifier (treatment), no sucking (post-treatment) |
| Outcomes | TcPO2 measured pre-intervention, during the intervention, post-intervention. |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | No | |
| Allocation concealment? | No | Pretest-post test design |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized, crossover |
|---|---|
| Participants | Mean gestational age - 28.8 weeks |
| Interventions | Experimental group: Pacifier during tube feeds. |
| Outcomes | Energy and nitrogen balance |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized, crossover |
| Allocation concealment? | Unclear | Randomized, crossover |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized, crossover |
|---|---|
| Participants | Gestational age - 1.0 - 2.0kg |
| Interventions | Experimental group: Pacifier during tube feed and after feed x 15 minutes or until in sleep state x 5 minutes. |
| Outcomes | Behaviour |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized, crossover |
| Allocation concealment? | No | Randomized, crossover |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized |
|---|---|
| Participants | Gestational age < 30 weeks |
| Interventions | Experimental group: Pacifier during feed and after feed for 30 minutes. |
| Outcomes | Anthropometric measures |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized |
| Allocation concealment? | Unclear | Blinding of randomization - Can't tell |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized, stratified |
|---|---|
| Participants | Gestational age < 35 weeks |
| Interventions | Experimental group: Pacifier during all tube feeds |
| Outcomes | Behaviour (assessed when in open crib) |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized, stratified |
| Allocation concealment? | Unclear | Blinding of randomization - Can't tell |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized |
|---|---|
| Participants | Gestational age < 34 weeks |
| Interventions | Experimental group: Pacifier before bottle feed x 5 minutes |
| Outcomes | Behaviour |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized |
| Allocation concealment? | Yes | Blinding of randomization - Yes |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized |
|---|---|
| Participants | Gestational age < 34 weeks |
| Interventions | Experimental group: Pacifier before bottle feed x 5 minutes |
| Outcomes | Behaviour |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized |
| Allocation concealment? | Yes | Blinding of randomization - Yes |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized |
|---|---|
| Participants | 30-35 weeks gestational age |
| Interventions | Experimental group: Pacifier during and after feeds and when awake. |
| Outcomes | Gastrin |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized |
| Allocation concealment? | Yes | Blinding of randomization - Yes |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized |
|---|---|
| Participants | Gestational age < 34weeks |
| Interventions | Experimental group 1: Sweet edible pacifier during tube feeds |
| Outcomes | Anthropometric measurements |
| Notes | Latex pacifier group used as experimental group for analysis |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized |
| Allocation concealment? | Yes | Blinding of randomization - Yes |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized, multiple crossover |
|---|---|
| Participants | Mean gestational age - 31.6 weeks |
| Interventions | Experimental group 1: Pacifier before bottle feeds x 10 minutes |
| Outcomes | Behaviour |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized, multiple crossover |
| Allocation concealment? | No | Randomized, multiple crossover |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized, crossover |
|---|---|
| Participants | Mean gestational age - 31.6 weeks |
| Interventions | Experimental group: Pacifier before bottle feeds x 10 minutes |
| Outcomes | Behaviour |
| Notes | The samples in McCain 1992 and 1995 are the same. McCain 1992 was the first phase of a study analyzing outcomes prior to feeds. This study analyzed the outcomes during feeds. |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized, crossover |
| Allocation concealment? | No | Randomized, crossover |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Alternate sequential series and matching |
|---|---|
| Participants | Gestational age 28 - 34 weeks |
| Interventions | Experimental group: Pacifier during tube feed and 5 minutes after feed |
| Outcomes | Weight gain |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Alternate sequential series and matching |
| Allocation concealment? | Unclear | Alternate sequential series and matching |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Method of allocation - uncertain |
|---|---|
| Participants | Gestational age - 26 - 34 weeks |
| Interventions | Expermental group: Pacifier before bottle feed x 5 minutes and after bottle feed x 5 minutes |
| Outcomes | Behaviour |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Method of allocation - uncertain |
| Allocation concealment? | Unclear | Method of allocation - uncertain |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized, crossover |
|---|---|
| Participants | Mean gestational age - 29.5 weeks |
| Interventions | Experimental group: Pacifier pre-bottle feed x 2 minutes prior to 2 feeds |
| Outcomes | Behaviour |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized, crossover |
| Allocation concealment? | Yes | Blinding of randomization - Yes |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized, crossover Blinding of randomization - No Blinding of intervention - No Blinding of outcome assessors - No Complete follow-up - Yes |
|---|---|
| Participants | Gestational age <32 weeks |
| Interventions | Experimental group: Pacifier pre-bottle feed x 2 minutes prior to 1 feed Control group: No pacifier for 1 feed |
| Outcomes | Behavioral state |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized, crossover |
| Allocation concealment? | No | Blinding of randomization - No |
| Blinding? | No | Blinding of intervention - No Blinding of outcome assessors - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Method of allocation - uncertain |
|---|---|
| Participants | Gestational age < 35 weeks |
| Interventions | Experimental group: Pacifier during tube feed x 3 minutes |
| Outcomes | Anthropometric measures |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Method of allocation - uncertain |
| Allocation concealment? | Unclear | Method of allocation - uncertain |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized, multiple cross-over |
|---|---|
| Participants | Gestational age - 33-36 weeks |
| Interventions | Experimental group: Pacifier during tube feed for 5 minutes |
| Outcomes | Gastric emptying |
| Notes | Group III not used in analysis |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized, multiple cross-over |
| Allocation concealment? | Yes | Blinding of randomization - Yes |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized, crossover |
|---|---|
| Participants | Mean gestational age - 32.3 weeks |
| Interventions | Experimental group: Pacifier 15 minutes before tube feed and during feed. Pacifier offered between feeds. |
| Outcomes | Somatostatin level |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized, crossover |
| Allocation concealment? | No | Blinding of randomization - No |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Non-randomized cross-over |
|---|---|
| Participants | AGA preterm infants receiving intermediate care |
| Interventions | NNS Period: Pacifier given 30 minutes after bottle feeding followed by no pacifier |
| Outcomes | Heart rate |
| Notes |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | No | Non-randomized cross-over |
| Allocation concealment? | No | Non-randomized cross-over |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Non-randomized cross-over |
|---|---|
| Participants | AGA preterm infants receiving intermediate level care |
| Interventions | Pacifier given between every other bottle feed x 12 hours |
| Outcomes | Heart rate |
| Notes | Outcomes assessed between feeds |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | No | Non-randomized cross-over |
| Allocation concealment? | No | Non-randomized cross-over |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Methods | Randomized cross-over |
|---|---|
| Participants | Gestational age < 37weeks. Birth weight < 2.0kg. Sample size = 11. 176 events analyzed (4 feeds/day x 4 days). |
| Interventions | Experimental groups: Group 1 received 3 minutes of NNS prior to bottle feeding: Group 2 received 5 minutes of NNS prior to bottle feeding. Control Group: No NNS |
| Outcomes | Amount of feeding in first 5 minutes |
| Notes | English translation from Chinese required. |
| Item | Judgement | Description |
|---|---|---|
| Adequate sequence generation? | Unclear | Randomized cross-over |
| Allocation concealment? | Unclear | Randomized cross-over |
| Blinding? | No | Blinding of intervention - No |
| Incomplete outcome data addressed? | Yes | Complete follow-up - Yes |
| Free of selective reporting? | Unclear | |
| Free of other bias? | Unclear |
| Reason for exclusion | Non-nutritive sucking is not the intervention |
|---|
| Reason for exclusion | Not experimental or quasi-experimental |
|---|
| Reason for exclusion | Not experimental or quasi-experimental |
|---|
| Reason for exclusion | Term infants |
|---|
| Reason for exclusion | Term infants |
|---|
| Reason for exclusion | Term infants |
|---|
| Reason for exclusion | No intervention |
|---|
| Reason for exclusion | Term infants |
|---|
| Reason for exclusion | Term infants |
|---|
| Reason for exclusion | Not experimental or quasi-experimental |
|---|
| Reason for exclusion | Not experimental or quasi-experimental |
|---|
| Reason for exclusion | Non-nutritive sucking not the primary intervention |
|---|
| Reason for exclusion | Term infants |
|---|
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| Outcome or Subgroup | Studies | Participants | Statistical Method | Effect Estimate |
|---|---|---|---|---|
| 1.1 Weight gain (g/day) | 3 | 103 | Mean Difference (IV, Fixed, 95% CI) | 1.57 [-0.37, 3.50] |
| 1.2 Heart rate (beats/min) | 4 | 126 | Mean Difference (IV, Fixed, 95% CI) | -1.42 [-5.90, 3.07] |
| 1.3 Oxygen saturation (%) | 3 | 72 | Mean Difference (IV, Fixed, 95% CI) | 1.04 [-0.04, 2.13] |
| 1.4 Length of hospital stay (days) | 2 | 87 | Mean Difference (IV, Fixed, 95% CI) | -7.15 [-12.60, -1.70] |
| 1.5 Intestinal transit time (hours) | 1 | 20 | Mean Difference (IV, Fixed, 95% CI) | -1.00 [-7.14, 5.14] |
| 1.6 Energy intake (kcal/kg/day) | 1 | 20 | Mean Difference (IV, Fixed, 95% CI) | -2.00 [-21.36, 17.36] |
| 1.7 Post-conceptional age at full oral feeds (days) | 1 | 28 | Mean Difference (IV, Fixed, 95% CI) | -1.70 [-46.06, 42.66] |
This review is published as a Cochrane review in The Cochrane Library, Issue 6, 2010 (see http://www.thecochranelibrary.com for information). Cochrane reviews are regularly updated as new evidence emerges and in response to feedback. The Cochrane Library should be consulted for the most recent version of the review. |