Antibiotics for Neurodevelopmental Outcomes in Preterm Infants

(NANO-FU Trial)

Recruiting in Palo Alto (17 mi)

+14 other locations

Overseen by Anup Katheria, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Sharp HealthCare

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of 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.

Research Team

Anup Katheria, MD

Principal Investigator

Sharp HealthCare

Eligibility Criteria

The NANO follow-up study is for families enrolled in the original NANO trial, which involves premature infants. It's not for low-risk infants or those with conditions like high risk of sepsis, respiratory issues requiring significant support, hemodynamic instability, major congenital anomalies, or prior antibiotic use.

Inclusion Criteria

Families that have agreed to participate and are enrolled in the parent NANO trial will be eligible for the NANO follow-up study. There will be no exclusions for eligible children entering the follow-up study.

My newborn was born between 23.0-30.6 weeks of gestation at a study site.

Exclusion Criteria

My infant needs a ventilator to breathe and requires a high level of oxygen.

Major congenital anomalies

My infant is at low risk for early onset sepsis.

Treatment Details

Interventions

• Ampicillin (Anti-bacterial agents)
• Gentamicin (Anti-bacterial agents)
• Placebo (Placebo)

Trial Overview This study tests whether withholding antibiotics from premature babies at birth can reduce neurodevelopmental disorders by age two. It compares outcomes between babies given Gentamicin and Ampicillin versus a placebo while considering genetic factors and gut bacteria.

Participant Groups

Group I: Very preterm infants that receive empiric antibiotic treatment in the first 48 hours of life Active Control 2 Interventions

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.

Group II: Very preterm infants that do not receive empiric antibiotic treatment in the first 48 hours of life Placebo Group 1 Intervention

Neonates in this group will have been enrolled and randomized into the NANO trial and received a blinded 48 hour course of placebo.

Ampicillin is already approved in Canada for the following indications:

Approved in Canada as Ampicillin for:

• Bacterial infections
• Urinary tract infections
• Respiratory tract infections
• Skin and soft tissue infections
• Gastrointestinal infections

Who Is Running the Clinical Trial?

Sharp HealthCare

Lead Sponsor

Trials

42

Recruited

17,600+

University of Pittsburgh

Collaborator

Trials

1,820

Recruited

16,360,000+

David Apelian

University of Pittsburgh

Chief Executive Officer since 2019

PhD in Molecular Biology from Rutgers University, MD from the University of Medicine and Dentistry of New Jersey, MBA from Quinnipiac University

Pamela D. Garzone

University of Pittsburgh

Chief Medical Officer

PhD in Clinical Science from the University of Pittsburgh

Morgan Stanley Children's Hospital

Collaborator

Trials

10

Recruited

5,012,000+

University of Louisville

Collaborator

Trials

353

Recruited

76,400+

Sharp Mary Birch Hospital for Women & Newborns

Collaborator

Trials

13

Recruited

6,600+

Children's Hospital of Philadelphia

Collaborator

Trials

749

Recruited

11,400,000+

Joseph W. St. Geme III

Children's Hospital of Philadelphia

Chief Medical Officer since 2021

MD, PhD, MPH

Madeline Bell

Children's Hospital of Philadelphia

Chief Executive Officer since 2015

BSc in Nursing from Villanova University, MSc in Organizational Dynamics from the University of Pennsylvania

Jefferson Medical College of Thomas Jefferson University

Collaborator

Trials

13

Recruited

13,900+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+

Dr. Barbara White

University of South Florida

Chief Medical Officer since 2021

MD, University of Pennsylvania School of Medicine

Dr. Sylvia W. Thomas

University of South Florida

Chief Executive Officer since 2023

Ph.D. in Electrical Engineering, University of South Florida

Westchester Medical Center

Collaborator

Trials

9

Recruited

6,500+

Yale University

Collaborator

Trials

1,963

Recruited

3,046,000+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University