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NOT YET RECRUITING
NCT05977400
PHASE3

NICU Antibiotics and Outcomes (NANO) Follow-up Study

Sponsor: Sharp HealthCare

View on ClinicalTrials.gov

Summary

The NANO follow-up study is designed to determine whether a simple, cost-effective intervention- withholding antibiotics at birth- reduces clinically relevant outcomes such as behavioral and neurological impairment at 2 years of age. This study will be the largest study evaluating the effects of early antibiotics in children with comprehensive measures of neurodevelopment linked to genomic variants and microbiota interactions.

Official title: NICU Antibiotics and Outcomes Follow-Up Study

Key Details

Gender

All

Age Range

23 Weeks - 30 Weeks

Study Type

INTERVENTIONAL

Enrollment

802

Start Date

2024-04

Completion Date

2029-03

Last Updated

2023-08-04

Healthy Volunteers

No

Interventions

DRUG

Ampicillin

Intravenous Ampicillin

DRUG

Gentamicin

Intravenous Gentamicin

DRUG

Placebo

Intravenous Normal Saline

Locations (15)

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, United States

Yale University

New Haven, Connecticut, United States

University of South Florida

Tampa, Florida, United States

University of Louisville

Louisville, Kentucky, United States

State University of New York Downstate

Brooklyn, New York, United States

Columbia University

New York, New York, United States

University of Rochester

Rochester, New York, United States

Westchester Medical Center

Valhalla, New York, United States

The Pennsylvania State University

Hershey, Pennsylvania, United States

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Jefferson Medical College of Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Magee-Womens Hospital

Pittsburgh, Pennsylvania, United States

The University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Sinai Health System

Toronto, Canada