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Should all preterm babies get extra nutrients? new study tests routine fortification

NCT ID NCT04284280

Disease control Sponsor: Crouse Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at 170 extremely preterm infants (born at or before 27 weeks) to see if adding a human milk fortifier to all feedings early on helps them grow better and reduces a dangerous gut condition called necrotizing enterocolitis. One group received the fortifier as soon as they reached full feeds, while the other group got it only if their weight gain was slow. The researchers tracked growth in the hospital and developmental outcomes at two years of age.

What this could mean

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

Active substance
Donor Human Milk Fortifier
What this could lead to
If successful, this could show that routine fortification of human milk improves growth and reduces serious gut complications in extremely preterm infants.
What could go wrong
This is a single-center study with 170 infants, so results may not apply to all hospitals. The intervention is a dietary supplement, not a drug, so benefits may be modest.

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

170 people

The number who actually took part.

Started

Feb 2020

Finished

Nov 2025

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

0 to 6 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: * All extremely preterm infants with gestational age less or equal to 27 weeks who are admitted to the NICU prior to day of life seven and the first enteral feeding Exclusion Criteria: * Infants with severe congenital anomalies such as chromosomal trisomy, congenital heart disease, and abdominal wall defect

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Conditions

The condition(s) this trial relates to.

necrotizing enterocolitis

As listed by the trial registrant

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

Necrotizing enterocolitis Poor growth in extremely preterm infants

Contacts and locations

Locations

  • Crouse Hospital

    Syracuse, New York, 13210, United States

More trials for these conditions

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