NICU Antibiotics and Outcomes Follow-Up Study

NANO Follow-Up

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.

2024-04-01

2029-03-01

2029-03-01

Not yet recruiting

Early phase I

802

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 caesarean section with rupture of membranes within 6 hours, without attempts to induce labor, and without concern for maternal infection 2. Infants at high risk for early onset sepsis- Infants born to mothers with intrapartum fever (\> 38ºC) or clinical diagnosis of chorioamnionitis (suspected or definite), infants born to mothers with proven Group B Streptococcus colonization or indication for intrapartum antibiotic prophylaxis that did not receive adequate antibiotic treatment according to specialty specific guidelines, (i.e., penicillin, ampicillin, cefazolin), infant born to mother with previous infant with GBS disease/infection 3. Infants with respiratory insufficiency requiring invasive mechanical ventilation and fraction of inspired oxygen\> 0.40 or non-invasive ventilation and fraction of inspired oxygen \> 0.60 at time of randomization 4. Infants with ongoing hemodynamic instability requiring vasopressors or more than one fluid bolus at time of randomization 5. Clinician concern for sepsis due to physical exam findings or clinical history of mother or infant 6. Major congenital anomalies 7. Infants not anticipated to survive beyond 72 hours 8. Infants who have received antibiotics prior to randomization.

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2023-08-04