Health TrialsbyHealthPanel

NICU Antibiotics and Outcomes (NANO) Follow-up Study

ConditionsPremature BirthAntibioticsNeurodevelopment
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Ampicillin

    Drug

    Intravenous Ampicillin

  • Gentamicin

    Drug

    Intravenous Gentamicin

  • Placebo

    Drug

    Intravenous Normal Saline

Treatment groups

802 Participants
are divided into 2 treatment groups
Group A: Very preterm infants that receive empiric antibiotic treatment in the first 48 hours of lifeActive comparator 2 interventions
Group B: Very preterm infants that do not receive empiric antibiotic treatment in the first 48 hours of lifePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Rate of neurodevelopmental impairment or Death

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.

Time frame
24 months corrected gestational age
2

DOOR probability Distribution

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.

Time frame
24 months corrected gestational age

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: