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NICU antibiotic study questions routine use for tiniest babies

NCT ID NCT03997266

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

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

359 people

The number who actually took part.

Started

Aug 2020

Finished

Jan 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Up to 4 hours

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

I. Inclusion criteria: We will enroll newborn infants with gestational age of 23-30 weeks 6 days infants at participating study sites will be eligible. II. Exclusion criteria: 1. Infants born for maternal indications via caesarean section with rupture of membranes at delivery, without attempts to induce labor, and without concern for maternal infection 2. Infants at high risk of EOS * Infants born to mothers with intrapartum fever (\> 38C) or clinical diagnosis of chorioamnionitis * Infants born to mothers with previous infant with GBS disease/infection 3. Infants with respiratory insufficiency requiring invasive mechanical ventilation and FiO2 \> 0.40 or non-invasive ventilation and FiO2 \> 0.60 at time of randomization 4. Infants with ongoing hemodynamic instability requiring vasopressors or fluid boluses at time of randomization 5. Clinician concern infant is at high risk for sepsis due to infant physical exam findings or clinical history of mother or infant 6. Major congenital anomalies 7. Infants not anticipated to survive beyond 72 hours 8. Infants who have received antibiotics prior to randomization 9. Mothers that are \<18 years old at time of enrollment

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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

More trials for these conditions

Other studies related to the condition(s) this trial covers.