Progress on Theme 5

Advancing Safe and Effective Therapeutics and Devices for Pregnant and Lactating Women, Children, and People with Disabilities

Highlighted Programs and Activities

  • NEW: Maternal and Pediatric Precision in Therapeutics (MPRINT) Hub
    The MPRINT Hub will serve as a national resource for expertise in maternal and pediatric therapeutics to conduct and foster therapeutics-focused research in obstetrics, lactation, and pediatrics while enhancing inclusion of people with disabilities. By serving as a national resource, MPRINT will disseminate the available knowledge, tools, and expertise in maternal and pediatric therapeutics to the broader research, regulatory science, and drug development communities. Learn more: RFA-HD-21-025 and RFA-HD-21-026.
  • NEW: Task Force on Research Specific to Pregnant Women and Lactating Women (PRGLAC) Implementation Plan
    PRGLAC issued its implementation plan (PDF 647 KB) to outline the steps necessary to implement its recommendations.

Selected Recent Advances

  • MRI technique could reduce need for radiation in measuring tumor response to chemotherapy in children (PMID: 32368961)
    Researchers compared whole-body diffusion-weighted magnetic resonance imaging (DW MRI), which measures the density of tumors by tracking the movement of water molecules in tissue, to fluorine 18 fluorodeoxyglucose positron emission tomography (FDG PET). Both techniques showed significant agreement in tracking tumor response to therapy, raising the possibility that DW MRI might one day be used in place of computerized tomography scanning, either together with FDG PET or alone, without the need to inject radioactive glucose. This new approach could reduce radiation exposure by 80% for combined FDG PET/DW MRI and fully eliminate radiation exposure for tumors that can be evaluated with DW MRI only.
  • Personal Protective Equipment (PPE) does not hinder pediatric Cardiopulmonary Resuscitation (CPR) (PMID: 32483079)
    Studies have shown that wearing PPE while performing CPR on adult manikins results in more fatigue and poorer quality chest compressions. However, researchers found no such effect in pediatric CPR; the quality of the compressions and fatigue levels were no different for PPE compared with usual clothing.
  • Effect of metformin treatment differs in gestational diabetes mellitus (GDM) and type 2 diabetes (PMID: 31742716)
    Researchers showed that the pharmacological response to metformin treatment was significantly different in pregnant women with GDM compared with nonpregnant women with type 2 diabetes. Despite similar metformin exposure, women with GDM had a greater improvement in insulin sensitivity and peak glucose concentrations than nonpregnant women with type 2 diabetes. These results provide evidence for more tailored treatments for GDM.
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