PTN, PHARMACEUTICALS (PK) AND SAFETY OF COMMONLY USED DRUGS IN LACTATING WOMEN AND BREASTFED INFANTS (CUDDLE 2.0) NETWORK

NIH RePORTER · NIH · N01 · $416,211 · view on reporter.nih.gov ↗

Abstract

ClinicalTrials.gov Identifier: NCT03511118 This groundbreaking study, conducted by the PTN, is designed to assess the safety of commonly used off-patent medications when they are given to breastfeeding mothers. It is common for new mothers to have symptoms or medical conditions that must be treated with drugs. These mothers often struggle with their decision to take their medications because of the fear that the drugs will harm their children. With this study, PTN aims to find doses of commonly used drugs that are safe for both mothers and their breastfed infants. The Pediatric Trials Network (PTN) is undertaking a groundbreaking study to assess the safety of commonly used off-patent medications when they are given to breastfeeding mothers. The study will track how different drugs are passed through breastmilk to determine dosing levels that are safe for both mom and baby. Although the U.S. Food and Drug Administration

Key facts

NIH application ID
10495378
Project number
275201800003I-0-759402100003-1
Recipient
DUKE UNIVERSITY
Principal Investigator
KANECIA ZIMMERMAN
Activity code
N01
Funding institute
NIH
Fiscal year
2021
Award amount
$416,211
Award type
Project period
2021-09-23 → 2024-09-22