About this trial
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 criteria
Qualifiers
None
Disqualifiers
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
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
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
Infants with ongoing hemodynamic instability requiring vasopressors or more than one fluid bolus at time of randomization
Trial design
Treatments tested in this trial
- Ampicillin
- Gentamicin
- Placebo
Treatment groups
Sponsors and collaborators
Sharp HealthCare
Lead sponsor
University of Pittsburgh
Collaborator
Morgan Stanley Children's Hospital
Collaborator
University of Louisville
Collaborator
Sharp Mary Birch Hospital for Women & Newborns
Collaborator
Children's Hospital of Philadelphia
Collaborator
Jefferson Medical College of Thomas Jefferson University
Collaborator
University of South Florida
Collaborator
Westchester Medical Center
Collaborator
Yale University
Collaborator
The University of Texas Health Science Center at San Antonio
Collaborator
Penn State University
Collaborator
State University of New York - Downstate Medical Center
Collaborator
Mount Sinai Hospital, Canada
Collaborator