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

> **NIH NIH N01** · DUKE UNIVERSITY · 2021 · $416,211

## 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 organization:** DUKE UNIVERSITY
- **Principal Investigator:** KANECIA ZIMMERMAN
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $416,211
- **Award type:** —
- **Project period:** 2021-09-23 → 2024-09-22

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10495378

## Citation

> US National Institutes of Health, RePORTER application 10495378, PTN, PHARMACEUTICALS (PK) AND SAFETY OF COMMONLY USED DRUGS IN LACTATING WOMEN AND BREASTFED INFANTS (CUDDLE 2.0) NETWORK (275201800003I-0-759402100003-1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10495378. Licensed CC0.

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