NICU Antibiotics and Outcomes (NANO) Follow-up Study

Part of paid clinical trials in San Diego, California.

Sponsor
Sharp HealthCare
Study ID
NCT05977400
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

  • Antibiotics
  • Neurodevelopment
  • Premature Birth

Eligibility Criteria

Sex
ALL
Age
23 Weeks - 30 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Ampicillin — DRUG
    Intravenous Ampicillin
  • Gentamicin — DRUG
    Intravenous Gentamicin
  • Placebo — DRUG
    Intravenous Normal Saline

Study Details

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.

Key Dates

Start date
Apr 30, 2024
Status verified
Jul 2023
Primary completion
Mar 31, 2029
Completion
Mar 31, 2029

Study Design

Enrollment
802 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Very preterm infants that receive empiric antibiotic treatment in the first 48 hours of life
    Neonates in this group will have been enrolled and randomized into the NANO trial and received a blinded 48 hour course of empiric antibiotic treatment.
  • Placebo Comparator: Very preterm infants that do not receive empiric antibiotic treatment in the first 48 hours of life
    Neonates in this group will have been enrolled and randomized into the NANO trial and received a blinded 48 hour course of placebo.

Primary Outcome Measure

Rate of neurodevelopmental impairment or Death [ Time Frame: 24 months corrected gestational age ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
Sharp Mary Birch Hospital for Women & NewbornsSan DiegoCalifornia92123
Anup C Katheria, MD
[email protected]
858-939-4170
Felix T Ines, RCP-RRT
[email protected]
858-939-4136
Anup C Katheria, MD (PRINCIPAL_INVESTIGATOR)
Yale UniversityNew HavenConnecticut06511
Angela Montgomery, MD
[email protected]
University of South FloridaTampaFlorida33620
Tara Randis, MD
[email protected]
University of LouisvilleLouisvilleKentucky40292
Elizabeth Schumacher
[email protected]
Tamina Singh, MD
[email protected]
State University of New York DownstateBrooklynNew York11203
Jacob Aranda, MD
[email protected]
Columbia UniversityNew YorkNew York10027
University of RochesterRochesterNew York14611
Carl D'Angio, MD
[email protected]
Westchester Medical CenterValhallaNew York10595-
The Pennsylvania State UniversityHersheyPennsylvania17033-0850
Chintan Gandhi, MD
[email protected]
Jefferson Medical College of Thomas Jefferson UniversityPhiladelphiaPennsylvania19107-
The Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Karen Puopolo, MD
[email protected]
Magee-Womens HospitalPittsburghPennsylvania15213-
The University of Pittsburgh Medical CenterPittsburghPennsylvania15213
Michael Morowitz, MD
[email protected]
University of Texas Health Science Center at San AntonioSan AntonioTexas78229
Leslie-Anne Dietrich
[email protected]

Find similar trials in San Diego, CA

By research site
Sharp Mary Birch Hospital for Women & Newborns· San Diego, CAYale University· New Haven, CTUniversity of South Florida· Tampa, FLUniversity of Louisville· Louisville, KYState University of New York Downstate· Brooklyn, NYColumbia University· New York, NY

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