Cure My Disease

Don't miss your cure!

 Log in / Sign up

Can starting iron sooner protect preterm babies on donor milk?

NCT ID NCT07816601

Prevention Sponsor: AdventHealth Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Very preterm infants fed donor breast milk can run low on iron because donor milk has less of it than formula or fortified feeds. This trial tests whether starting an oral iron supplement earlier, once an infant tolerates 80 ml of milk per kilogram per day instead of waiting for full feeds, raises iron stores and red blood cell levels. Researchers will measure ferritin and hematocrit in 17 infants born between 29 and 32 weeks of gestation at about 14 and 28 days of life. The goal is to see whether earlier iron helps this vulnerable group avoid iron deficiency anemia.

What this could mean

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

Active substance
ferrous sulfate, an oral iron supplement
What this could lead to
If it works, this could give neonatal units a simple way to protect preterm infants on donor milk from iron deficiency, which can affect growth and brain development.
What could go wrong
The trial is small, with 17 infants, and measures iron and hematocrit levels rather than long-term health outcomes. Early iron may not raise ferritin enough, and preterm infants can face feeding problems or other complications that disrupt the protocol.

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 17 people

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

Started

May 2026

Expected to finish

Dec 2027

An estimate. End dates often move.

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

29 to 33 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\. All preterm infants born between 29.0-32.6 weeks of gestational age and admitted to the NICU at Advent Health for Children 2. Infants likely to be receiving DBM between 5 to 14 days of life 3. Infants receiving \>50% of the feeding volume by DBM will be considered to have received DBM. Exclusion Criteria: 1. Death prior to completion of participation or extremis with likelihood of death prior to completion of participation in the study 2. Blood transfusion as determined by clinical team during the study 3. Major congenital anomaly or genetic syndrome and major surgical GI conditions that preclude feeding

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Iron deficiency anemia are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

Conditions

The condition(s) this trial relates to.

iron deficiency anemia Premature Birth

As listed by the trial registrant

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

Iron deficiency anemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth Orlando

    RECRUITING

    Orlando, Florida, 32803, United States

More trials for these conditions

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