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Could timed light therapy save more premature babies?

NCT ID NCT03927833

Disease control Sponsor: NICHD Neonatal Research Network 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways of using phototherapy (light treatment) for jaundice in extremely premature infants (under 750 grams or 27 weeks gestation). One group gets continuous light, the other gets timed cycles based on bilirubin levels. The main goal is to see if cycled phototherapy helps more babies survive to go home. The trial has enrolled 1,700 infants across multiple centers.

What this could mean

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

Active substance
Phototherapy lights (device)
What this could lead to
If it works, this could lead to a safer, more effective way to treat jaundice in extremely premature babies, potentially improving survival.
What could go wrong
This is a large trial, but results are not yet published. The approach may not prove better than standard continuous phototherapy, and individual responses may vary.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 1,700 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

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

Ages

22 to 27 weeks

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.

Inclusion Criteria: 1. Infants is inborn 2. Infant is ≤ 750 grams at birth and/or \< 27 weeks gestation at birth by best OB estimate 3. Infant is 12-36 hours of age. Exclusion Criteria: 1. Unable to enroll infant by 36 hours of age 2. Previous phototherapy 3. Known hemolytic disease 4. TSB reported as \>6.0 mg/dL before 12 hours age 5. Major anomaly 6. Overt nonbacterial infection 7. Infant is likely to expire soon: Limiting or withdrawal of intensive care is being recommended to the parents, the parents are requesting withdrawal of care, or the pH is \< 6.80 or persistent bradycardia with hypoxemia for \>2h.

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Conditions

The condition(s) this trial relates to.

hyperbilirubinemia Infant, Newborn, Diseases Premature Birth

As listed by the trial registrant

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

Hyper bilirubinemia Premature infant

Contacts and locations

Locations

  • Brown University - Women and Infants Hospital of Rhode Island

    Providence, Rhode Island, 02905, United States

  • Case Western Reserve University, Rainbow Babies and Children's Hospital

    Cleveland, Ohio, 44106, United States

  • Cincinnati Children's Medical Center

    Cincinnati, Ohio, 45267, United States

  • Duke University

    Durham, North Carolina, 27710, United States

  • Emory University

    Atlanta, Georgia, 30303, United States

  • Northwestern Lurie Children's Hospital of Chicago

    Chicago, Illinois, 60611, United States

  • RTI International

    Durham, North Carolina, 27705, United States

  • Research Institute at Nationwide Children's Hospital

    Columbus, Ohio, 43205, United States

  • Sharp Mary Birch Hospital for Women & Newborns

    San Diego, California, 92123, United States

  • Stanford University

    Palo Alto, California, 94304, United States

  • Univeristy of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Iowa

    Iowa City, Iowa, 52242, United States

  • University of Mississippi Medical Center - Children's of Mississippi

    Jackson, Mississippi, 39216, United States

  • University of New Mexico

    Albuquerque, New Mexico, 87131, United States

  • University of Rochester

    Rochester, New York, 14642, United States

  • University of Texas Health Science Center at Houston

    Houston, Texas, 77030, United States

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75235, United States

  • University of Utah

    Salt Lake City, Utah, 84108, United States

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