Advancing Safe and Effective Therapeutics and Devices for Pregnant and Lactating Women, Children, and People with Disabilities
Highlighted Programs and Activities
Multisite clinical research: Leveraging network infrastructure to advance research for women, children, pregnant and lactating individuals, and persons with disabilities NICHD invites applications for multisite clinical trials and observational studies developed in conjunction with NICHD networks that will be conducted using NICHD-supported network infrastructure. This program is designed to: enhance the rigor and reproducibility of clinical trial protocols; promote greater availability of multisite clinical trial infrastructure to support trials from a wider range of investigators; facilitate data sharing and access to biospecimens to efficiently expand research capacity; and support greater involvement of diverse populations in multisite clinical trials. Learn more: PAR-23-037.
Translational research in maternal and pediatric pharmacology and therapeutics NICHD has issued this opportunity to support translational and clinical research to: advance precision medicine in pregnant persons, lactating persons, and children through the development of novel tools, models, and other technologies that could have a direct clinical or health impact; enhance the understanding of the underlying mechanisms of drug action, including the role of pediatric ontogeny and the dynamic physiological changes that occur during pregnancy and lactation; and discover and develop novel therapeutics or enhance the usage of existing drugs or drug repurposing for safer and more effective medications in pregnant and lactating persons, neonates, and children. The overall goal is to improve safe and effective precision therapeutics for pregnant and lactating persons, fetuses, neonates, and children, including those with disabilities. Learn more: PAR-23-130 and PAR-23-131.
Selected Recent Advances
Step monitoring and coaching more effective at improving physical activity after stroke than traditional therapy (PMID: 38134254) From 6 to 12 months after having a stroke, more than half of survivors have trouble walking and less independence. Often, therapy seeking to increase activity levels in stroke survivors has been designed to increase their capacity—that is, increase the walking speed and distance a stroke survivor can achieve during a therapy session in a clinic. However, these studies generally do not lead to improvements in walking performance—the amount of walking patients do in their unstructured, everyday environment. Researchers compared a traditional high-intensity walking program to a performance improvement program in which participants wore a step monitor and met with a therapist who reviewed their walking progress and helped them set future goals. The study’s participants were assigned at random to either the traditional high-intensity walking program, the performance improvement program, or a program that combined the two therapies. After completing their programs, all participants wore a Fitbit for at least three days. The study showed that the step monitoring program alone was most effective at increasing daily activity, followed by the combined high intensity/step count program. The least effective program was the high intensity walking program alone.
Fluconazole drug labeling updated for use in infants Fluconazole, which is available in both oral and injectable forms, is prescribed to prevent and treat various fungal infections. Health care providers often use it to treat infants with candidiasis, an infection caused by Candida yeast. Without treatment, Candida can enter the bloodstream, spread throughout the body, and cause life-threatening complications. Babies born prematurely or at very low birth weight are particularly susceptible to bloodstream infections with Candida. However, previous fluconazole labels contained extremely limited information about how to use the drug in infants. The newly revised drug labels incorporate data from several studies. They include information about how fluconazole is distributed, metabolized, and cleared in newborns and older infants and provide dosing suggestions.
Improving incline walking mechanics and muscle activity in people with cerebral palsy (PMID: 38219555) Ankle dysfunction affects more than half of people with cerebral palsy, impairing their ability to walk. Researchers measured the gait of 12 children and young adults with cerebral palsy while they walked on a treadmill at a 5-degree incline for 1 minute at a time. While walking, participants wore either a motor-powered ankle exoskeleton to help move the ankle joint, a foot pad that provides foot pressure biofeedback to encourage greater force when pressing one’s foot into the walking surface, both devices at once, or neither device. Both devices were helpful. Compared to incline walking without additional support, wearing the ankle exoskeleton alone led to better ankle and foot control; the biofeedback device alone increased ankle movement and power and increased foot activity; and wearing both devices together increased ankle and knee power. Notably, in individuals with more severe cerebral palsy, greater ankle movement was only achieved when wearing both devices, suggesting this approach may be effective for those with more severe walking impairment.
Exposure-response relationships of metronidazole in infants (PMID: 36201670) Metronidazole is an antibiotic that is commonly used in infants to prevent surgical site infection and treat infections. Despite its widespread use, it is not currently approved for children by the U.S. Food and Drug Administration (FDA), and data on metronidazole in children are sparse. Seizures are a rare (but potentially devastating) side effect of metronidazole, yet the prevalence of seizures in infants, as well as the relationship with metronidazole dose and exposure, are unknown. Researchers applied an existing model and used data from a national dataset of electronic health records (EHR) of more than 1 million infants in intensive care units across the United States. In this dataset, 19,367 intravenous doses of metronidazole were given to 1,546 infants; 31 of these infants experienced a seizure. With this modeling strategy, researchers identified that longer metronidazole exposure and higher cumulative exposure could be associated with increased odds of infant seizures. Further prospective studies are required to validate these findings and discern the safest prescribing practices for metronidazole in infants.
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