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.
Eligibility
Sex
ALL
Min age
23 Weeks
Max age
30 Weeks
Healthy volunteers
No
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.
Primary outcome measure(s)
Rate of neurodevelopmental impairment or Death — 24 months corrected gestational age The first primary outcome will be a composite of newborn or childhood death OR one of following: cognitive or motor composite scores \<80 on the Bayley-4, Gross Motor Function Classification Score score ≥2, bilateral blindness, severe functional hearing impairment. The incidence of the composite outcome will be compared between the placebo and early antibiotic groups.
DOOR probability Distribution — 24 months corrected gestational age The second primary outcome will be a comparison of the DOOR probability of more desirable outcomes at 2 years using a novel ordinal endpoint scale developed during the trial. Outcomes to be included in the rank are as follows: death, cognitive/language/motor composite scores\<80 on the Bayley-4, Gross Motor Function Classification Score ≥2, bilateral blindness, severe functional hearing impairment, Child Behavior Checklist (CBCL) scores \>70, autism risk scores (MCHAT R/F) of ≥2, and medical measures, such as need for oxygen support. The distribution of the finalized neoDOOR will be compared between the placebo and empiric antibiotic groups.
Trial sites (15)
Facility
City
Region
Status
Sharp Mary Birch Hospital for Women & Newborns
San Diego
California
Yale University
New Haven
Connecticut
University of South Florida
Tampa
Florida
University of Louisville
Louisville
Kentucky
State University of New York Downstate
Brooklyn
New York
Columbia University
New York
New York
University of Rochester
Rochester
New York
Westchester Medical Center
Valhalla
New York
The Pennsylvania State University
Hershey
Pennsylvania
The Children's Hospital of Philadelphia
Philadelphia
Pennsylvania
Jefferson Medical College of Thomas Jefferson University
Philadelphia
Pennsylvania
Magee-Womens Hospital
Pittsburgh
Pennsylvania
The University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
University of Texas Health Science Center at San Antonio
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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