NICU Antibiotics and Outcomes Trial

PHASE4Active, not recruitingINTERVENTIONAL
Enrollment

802

Participants

Timeline

Start Date

August 5, 2020

Primary Completion Date

September 1, 2026

Study Completion Date

June 1, 2027

Conditions
Microbial ColonizationExtreme PrematurityEarly-Onset Neonatal SepsisLate-Onset Neonatal SepsisNecrotizing Enterocolitis of NewbornDeath; Neonatal
Interventions
DRUG

Ampicillin

Intravenous ampicillin

DRUG

Gentamycin

Intravenous gentamycin

DRUG

Normal saline

Intravenous normal saline

Trial Locations (14)

10595

Maria Fareri Children's Hospital at Westchester Medical Center, Valhalla

14642

Golisano Children's Hospital at University of Rochester, Rochester

15213

Magee Womens Hospital, Pittsburgh

17033

Penn State Medical College, Hershey

19104

Pennsylvania Hospital/The Children's Hospital of Philadelphia, Philadelphia

19107

Alfred I. duPont for Children of the Nemours Foundation, Philadelphia

27157

Atrium Health Wake Forest Baptist, Winston-Salem

33606

University of South Flordia Health, Tampa

36688

USA Children's and Women's Hospital, Mobile

40202

University of Louisville Research Foundation Inc./Kosair Charities Pediatric Clinical Research Unit, Louisville

78229

University of Texas Health Science Center at San Antonio, San Antonio

92123

Sharp Mary Birch Hospital for Women & Newborns, San Diego

06520-8064

Yale University School of Medicine, New Haven

10032-3702

The Trustees of Columbia University in the City of New York, New York

All Listed Sponsors
collaborator

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

lead

Michael Morowitz

OTHER