NICU Antibiotics and Outcomes (NANO) Follow-up Study

Summary

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.

Conditions

• Premature Birth
• Antibiotics
• Neurodevelopment

Interventions

DRUG

Ampicillin

Intravenous Ampicillin

DRUG

Gentamicin

Intravenous Gentamicin

DRUG

Placebo

Intravenous Normal Saline

Sponsors & Collaborators

• University of Pittsburgh

  collaborator OTHER

• Morgan Stanley Children's Hospital

  collaborator OTHER

• University of Louisville

  collaborator OTHER

• Sharp Mary Birch Hospital for Women & Newborns

  collaborator OTHER

• Children's Hospital of Philadelphia

  collaborator OTHER

• Jefferson Medical College of Thomas Jefferson University

  collaborator OTHER

• University of South Florida

  collaborator OTHER

• Westchester Medical Center

  collaborator OTHER

• Yale University

  collaborator OTHER

• The University of Texas Health Science Center at San Antonio

  collaborator OTHER

• Penn State University

  collaborator OTHER

• State University of New York - Downstate Medical Center

  collaborator OTHER

• Mount Sinai Hospital, Canada

  collaborator OTHER

• Sharp HealthCare

  lead OTHER

Principal Investigators

• Anup Katheria, MD · Sharp HealthCare

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

23 Weeks

Max Age

30 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-30

Primary Completion

2029-03-31

Completion

2029-03-31

FDA Drug

Yes

Countries

• United States
• Canada

Study Locations