Pharmacology: Clinical Trials

The NICHD conducts and supports a variety of clinical research related to pharmacology. Select a link below to learn more about these projects.

Featured NICHD Clinical Trials

  • The Pharmacokinetics of Oral Methadone in the Treatment of Neonatal Abstinence Syndrome (NAS)
    This trial is studying how the bodies of infants with NAS process the drug methadone, which is used to help people overcome opioid addictions. The researchers hope this information will help find the best treatment for infants with this syndrome.
  • Free Fatty Acids, Body Weight, and Growth Hormones Secretion in Children
    The goal of this study is to determine how changes in blood levels of free fatty acids affect growth hormone secretion in overweight or shorter children and young teens. Children who are overweight and obese often have lower levels of growth hormone in the blood, which can affect height. Body weight and the amount of free fatty acids in the blood can affect the regulation of growth hormone.
  • PK of Antistaphylococcal Antibiotics in Infants (NICHD-2012-02-Staph Trio)
    This trial is studying how infants’ bodies break down antibiotic drugs that are designed to combat infections of the dangerous Staphylococcus (staph) bacterium.
  • A Study of the Pharmacology of Tamiflu in Pregnancy
    The purpose of this study is to determine the pharmacokinetics of the antiflu medication Tamiflu during pregnancy and to determine to what extent pregnancy may affect the currently recommended dosage of this drug.
  • Codeine in Mechanically Ventilated Neonates
    Researchers hope to determine the absorption and bioavailability of codeine in relation to postnatal and postconception age.
  • Safety and Effectiveness of Oral Alendronate Therapy on Bone Mineral Density in HIV-infected Children and Adolescents with Low Bone Mineral Density
    HIV-infected children, youth, and adults have lower bone mineral density (BMD) than would be expected for HIV-uninfected people of similar age, weight, and race. The potential for HIV-related impaired BMD during the adolescent peak of bone mass acquisition is of particular concern. The primary purpose of this study is to compare changes from pretreatment levels of BMD of the lumbar spine after 24 and 48 weeks of alendronate treatment with changes using placebo in HIV-infected children and adolescents.
  • Safety and Efficacy Study of Lithium for the Treatment of Pediatric Mania (Lithium2)
    This is the second study of a multiphase, multicenter trial that will comprehensively examine lithium in the treatment of pediatric participants with bipolar I disorder.
  • Study of Effects of Tenofovir on Bone Health and Kidneys During Pregnancy and Breastfeeding
    The purpose of this study is to look at the effects of tenofovir disoproxil fumarate (an anti-HIV medication) on the bone health and kidneys of women with HIV during pregnancy and while breastfeeding. The study will also look at changes in overall health, bone health, and the functioning of the kidneys in the infants of these women.
  • Treatment of Hypoparathyroidism with Synthetic Human Parathyroid Hormone 1-34
    Over the past two decades, this study has been important in establishing parathyroid hormone as a beneficial treatment for hypoparathyroidism, one that is superior to conventional therapy with calcium and calcitriol.
  • Growth Hormone Therapy in Osteogenesis Imperfecta
    This study investigates growth patterns in children with osteogenesis imperfecta. Different medications have been tried to both stimulate their growth and improve their bone density. Some children have responded to growth hormone (their growth rate increased by at least 50%), and some did not. The majority of children who did respond had Type IV osteogenesis imperfecta. This study is recruiting more children to try to determine which children will benefit from growth hormone medication.
  • Pharmacokinetics (PK) of Liquid Hydroxyurea in Pediatric Patients With Sickle Cell Anemia (HU)
    Hydroxyurea (HU) is approved by the U.S. Food and Drug Administration (FDA) to treat adults with sickle cell anemia. HU has also been tested and used with children with sickle cell anemia. However, there are not many studies describing the disposition of drug in children less than 5 years old. The FDA has requested this study to better understand how children 2 to 17 years old with sickle anemia absorb and eliminate the drug (this is called pharmacokinetics). The investigators will measure how much HU gets into the bloodstream at different time points after taking this medication.
  • Safety Study of Lisinopril in Children and Adolescents With a Kidney Transplant (PTN_LISINO)
    The drug lisinopril is approved by the FDA for the treatment of high blood pressure, heart failure, and acute heart attacks in adult patients. In children over 6 years of age, lisinopril is approved for the treatment of high blood pressure. There is some information available about how children with high blood pressure absorb, distribute, metabolize, and eliminate lisinopril. However, there is no information about how children with high blood pressure who have received a kidney transplant process lisinopril. In addition to decreasing blood pressure, investigators believe that lisinopril may help kidney transplants work longer. A clinical trial will be conducted in the future to compare which medication group helps kidney transplants in children last longer. To guide the selection of the best dose to test in future studies, investigators in this study will try to determine the safety profile, dose tolerability, and pharmacokinetics of lisinopril in children and adolescents (2–17 years of age) who have received a kidney transplant and have high blood pressure.
  • Pharmacokinetics of Understudied Drugs Administered to Children per Standard of Care
    The purpose of this study is to characterize the pharmacokinetics of understudied drugs administered to children per standard of care as prescribed by their treating caregiver. This will be accomplished by the collection of biological samples during the time of drug administration per standard of care as prescribed by the caregiver.

NICHD Clinical Trials Search Results

Information on current NIH-sponsored clinical trials on pharmacology is available by following the link below or by calling 800-411-1222.

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