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Study probes link between transfusions and gut trouble in preterm infants

NCT ID NCT02741648

Knowledge-focused Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study looked at 324 extremely low birth weight preterm infants (≤1250 grams) to see how anemia and red blood cell transfusions affect oxygen levels in their digestive tract. Researchers used a non-invasive device to measure tissue oxygen and collected blood, urine, and stool samples. The goal was to find clues that might explain why some babies develop necrotizing enterocolitis, a serious gut condition.

What this could mean

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

What this could lead to
If successful, this research could help doctors better understand why some preterm infants develop a serious gut condition called necrotizing enterocolitis after a transfusion.
What could go wrong
This is an observational study, not a treatment trial. It aims to gather information, not test a new therapy, so it will not directly change care yet.

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.

Participants

324 people

The number who actually took part.

Started

Jul 2016

Finished

Feb 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.

Who is studied

Extremely low birth weight newborn infants born at Emory University Hospital Midtown, Grady Health System, and Northside Hospital Neonatology. Infants will be followed at Children's Healthcare of Atlanta.

Ages

1 day to 5 days

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: * Birth weight ≤1250 grams * Postnatal age within 7 days of birth Exclusion Criteria: * Infant not expected to live beyond 7 days of life based on assessment of treating neonatologist * Severe congenital abnormality expected to affect life expectancy * RBC or platelet transfusion at an outside institution occurring prior to screening * Maternal refusal to participate

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Conditions

The condition(s) this trial relates to.

anemia necrotizing enterocolitis

As listed by the trial registrant

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

Anemia Necrotizing enterocolitis

Contacts and locations

Locations

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303, United States

  • Northside Hospital - Neonatology

    Atlanta, Georgia, 30342, United States

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