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NICU Antibiotics and Outcomes (NANO) Follow-up Study
Sponsor: Sharp HealthCare
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
Ampicillin
Intravenous Ampicillin
Gentamicin
Intravenous Gentamicin
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