NICU Antibiotics and Outcomes Trial

Launched by MICHAEL MOROWITZ · Jun 21, 2019

Keywords

ClinConnect Summary

The NICU Antibiotics and Outcomes Trial, also known as the NANO trial, is studying how giving antibiotics to very tiny newborns, specifically those born weighing less than 1,000 grams, affects their health. Researchers want to find out if these babies experience more health problems, such as infections or serious digestive issues, when given antibiotics in the first week of life compared to those who receive a placebo (a treatment with no active medication). The trial will include newborns born between 23 and 30 weeks of pregnancy who are stable and don’t have known infections.

Parents of eligible babies can expect their child to participate in a study where they will randomly receive either antibiotics or a placebo for the first week after birth. The study will track various health measures, including any infections and overall growth. It’s important to note that certain babies, such as those with specific health conditions or those who have already received antibiotics, will not be included in the trial. This research aims to provide clearer guidance on the best use of antibiotics in the NICU to improve outcomes for these vulnerable infants.

Gender

ALL

Eligibility criteria

• • 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