NICU Antibiotics and Outcomes (NANO) Follow-up Study

Launched by SHARP HEALTHCARE · Jul 28, 2023

Keywords

ClinConnect Summary

The NANO follow-up study is exploring whether not giving antibiotics to newborns at birth can lead to better brain and behavior outcomes by the time they are 2 years old. This research is important because it will be the largest study of its kind, looking at how early antibiotic use affects children's development while considering their unique genetic makeup and gut bacteria.

To participate, families must be part of the original NANO trial, which involves newborns born very early (between 23 and 30 weeks of pregnancy) at selected hospitals. Eligible infants are those who are not at high risk for infections and have not received antibiotics before randomization. Families in the study can expect ongoing support and assessments related to their child’s development over time. This research could provide valuable insights into the best practices for treating premature infants and their long-term health.

Gender

ALL

Eligibility criteria

• • 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.