NICU Antibiotics and Outcomes (NANO) Follow-up Study

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age23-30
SponsorSharp HealthCare

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

802 Participants
are divided into 2 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