NICU antibiotic study questions routine use for tiniest babies

NCT ID NCT03997266

Completed Knowledge-focused Sponsor: Michael Morowitz Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study looked at whether giving antibiotics early to extremely low birthweight babies (born before 31 weeks) might cause more harm than good. Researchers compared babies who got standard antibiotics to those who got a placebo. The goal was to see if early antibiotics increase the risk of serious infections, bowel disease, or death. The trial enrolled 359 infants and aimed to help doctors make better decisions about antibiotic use in the NICU.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Ampicillin, Gentamycin, Normal saline
What this could lead to: If this trial shows that early antibiotics increase risks, it could lead to safer, more selective antibiotic use in NICUs, reducing harm to fragile newborns.
What could go wrong: This is a completed Phase 4 trial, but results may not apply to all premature infants. The study is observational in nature, so it cannot prove cause and effect.

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Conditions

The condition(s) this trial relates to.

infectious disease necrotizing enterocolitis neonatal sepsis Perinatal Death perinatal necrotizing enterocolitis Premature Birth

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

DEATH; NEONATAL EARLY-ONSET NEONATAL SEPSIS EXTREME PREMATURITY LATE ONSET NEONATAL SEPSIS MICROBIAL COLONIZATION NECROTIZING ENTEROCOLITIS OF NEWBORN

Contacts and locations

Locations

Alfred I. duPont for Children of the Nemours Foundation

Philadelphia, Pennsylvania, 19107, United States
Atrium Health Wake Forest Baptist

Winston-Salem, North Carolina, 27157, United States
Golisano Children's Hospital at University of Rochester

Rochester, New York, 14642, United States
Magee Womens Hospital

Pittsburgh, Pennsylvania, 15213, United States
Maria Fareri Children's Hospital at Westchester Medical Center

Valhalla, New York, 10595, United States
Penn State Medical College

Hershey, Pennsylvania, 17033, United States
Pennsylvania Hospital/The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States
Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, 92123, United States
The Trustees of Columbia University in the City of New York

New York, New York, 10032-3702, United States
USA Children's and Women's Hospital

Mobile, Alabama, 36688, United States
University of Louisville Research Foundation Inc./Kosair Charities Pediatric Clinical Research Unit

Louisville, Kentucky, 40202, United States
University of South Flordia Health

Tampa, Florida, 33606, United States
University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States
Yale University School of Medicine

New Haven, Connecticut, 06520-8064, United States

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