NICU Antibiotics and Outcomes Follow-Up Study
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.
Description
The multidisciplinary team launched the NANO (NICU Antibiotics and Outcomes) Trial to study the longstanding clinical practice of empirically administering intravenous antibiotics to very preterm infants. The NANO trial is an 802-patient,13-site randomized blinded controlled trial (R01HD09757801) discerning whether administration of antibiotics within the first three days of life increases the incidence of short-term, life-threatening complications among very preterm infants. The proposed NANO follow-up study will build upon the parent NANO trial to determine whether avoiding antibiotics in v…
Eligibility
- Age range
- 0–0 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Families that have agreed to participate and are enrolled in the parent NANO trial will be eligible for the NANO follow-up study. There will be no exclusions for eligible children entering the follow-up study. Parent NANO trial Criteria: I. Inclusion criteria: We will enroll newborn infants with gestational age of 23.0-30.6 weeks born to mothers 18 years or older at participating study sites. Only inborn infants at participating study sites will be eligible. II. Exclusion criteria: 1. Infants at low risk for early onset sepsis-Infants born for maternal indications via c…
Interventions
- DrugAmpicillin
Intravenous Ampicillin
- DrugGentamicin
Intravenous Gentamicin
- DrugPlacebo
Intravenous Normal Saline
Locations (15)
- Sharp Mary Birch Hospital for Women & NewbornsSan Diego, California
- Yale UniversityNew Haven, Connecticut
- University of South FloridaTampa, Florida
- University of LouisvilleLouisville, Kentucky
- State University of New York DownstateBrooklyn, New York
- Columbia UniversityNew York, New York