drugset / Trial / NCT05977400
NICU Antibiotics and Outcomes (NANO) Follow-up Study
Phase 3
Not yet recruiting
802 enrolled
Sharp HealthCare
Children's Hospital of Philadelphia · collabJefferson Medical College of Thomas Jefferson University · collabMorgan Stanley Children's Hospital · collabMount Sinai Hospital, Canada · collabPenn State University · collabSharp Mary Birch Hospital for Women & Newborns · collabState University of New York - Downstate Medical Center · collabThe University of Texas Health Science Center at San Antonio · collabUniversity of Louisville · collabUniversity of Pittsburgh · collabUniversity of South Florida · collabWestchester Medical Center · collabYale University · collab
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2024-04
- Primary completion
- 2029-03
- Completion
- 2029-03
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ampicillin | Unknown | — | Intravenous |
| Comparator | Gentamicin | Small molecule | — | Intravenous |