NICU Antibiotics and Outcomes Trial

PRO18010284

The goal of the NANO trial is to study the longstanding clinical practice of empirically administering intravenous antibiotics to extremely low birthweight (ELBW) infants in the first days of life. In this 802-subject multicenter placebo-controlled randomized clinical trial, the hypothesis to be tested is that the incidence of adverse outcomes is higher in babies receiving empiric antibiotics (EA) in the first week of life compared to babies receiving placebo. The study targets a population of ELBW infants in whom the clinical decision to use or not use EA is currently most challenging -- infants that are clinically stable that did not have a known exposure to intraamniotic infection and were not born preterm for maternal indications. The primary outcome is the composite outcome of late-onset sepsis (LOS), necrotizing enterocolitis (NEC), or death during the index hospitalization. Secondary safety outcomes will include total antibiotic days, days to full enteral feedings, and common morbidities in preterm infants that have previously been linked to EA, e.g. retinopathy of prematurity and bronchopulmonary dysplasia. Weight and length z-score, and head circumference, are standard measures to be collected weekly by clinical team per a standardized protocol.

2020-08-05

2025-09-01

2026-06-01

Recruiting

Early phase I

802

I. Inclusion criteria: We will enroll newborn infants with gestational age of 23-30 weeks 6 days infants at participating study sites will be eligible. II. Exclusion criteria: 1. Infants born for maternal indications via caesarean section with rupture of membranes at delivery, without attempts to induce labor, and without concern for maternal infection 2. Infants at high risk of EOS * Infants born to mothers with intrapartum fever (\> 38C) or clinical diagnosis of chorioamnionitis * Infants born to mothers with previous infant with GBS disease/infection 3. Infants with respiratory insufficiency requiring invasive mechanical ventilation and FiO2 \> 0.40 or non-invasive ventilation and FiO2 \> 0.60 at time of randomization 4. Infants with ongoing hemodynamic instability requiring vasopressors or fluid boluses at time of randomization 5. Clinician concern infant is at high risk for sepsis due to infant 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 9. Mothers that are \<18 years old at time of enrollment

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 802, 'type': 'ESTIMATED'}}

2024-01-17