NICU Antibiotics and Outcomes Trial

• Status: Recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Michael Morowitz
• Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); National Institutes of Health (NIH)
• Treatments: Ampicillin; Anti-Bacterial Agents; Antibiotics, Antitubercular; Gentamicins

Criteria

Inclusion criteria: We will enroll inborn preterm infants born at participating study sites with a gestational age of 23-28 6/7 weeks.

Exclusion criteria:

1. Infants born for maternal indications via caesarean section with rupture of membranes within 6 hours of delivery, without attempts to induce labor, and without concern for maternal infection

2. Infants born to mothers with intrapartum fever (> 38ºC) or clinical diagnosis of chorioamnionitis

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 more than one fluid bolus at time of randomization

5. Clinician concern for sepsis due to physical exam findings, e.g. lethargy

6. Major congenital anomalies

7. Infants not anticipated to survive beyond 72 hours

8. Infants who have received antibiotics prior to randomization.

9. Mothers <18 years old at the time of enrollment