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New iron formula could protect preterm infants from anemia

NCT ID NCT07667205

Prevention Sponsor: Ain Shams University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a newer form of iron (liposomal iron) works better than standard iron drops to prevent iron deficiency anemia in premature babies. About 60 preterm infants born at or before 34 weeks will receive either daily standard iron, daily liposomal iron, or liposomal iron every other day. Researchers will measure blood levels of hemoglobin and iron stores to compare the approaches.

What this could mean

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

Active substance
liposomal iron and ferrous iron (oral drops)
What this could lead to
If successful, this could point toward a better-tolerated or more effective way to prevent iron deficiency anemia in preterm infants.
What could go wrong
This is a very early phase 1 trial with only 60 participants, so results may not be conclusive. Liposomal iron is newer and may not prove superior to standard iron.

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 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 60 people

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

Started

Jul 2025

Expected to finish

Dec 2026

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

2 to 3 weeks

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Preterm neonates Gestational age ≤ 34 weeks who can tolerate oral feeding. * Brith weight \<2500gm. Exclusion Criteria: * Major Surgical procedures. * Major Chromosomal anomaly. * Inborn error of metabolism. * GIT anomalies. * Neonatal sepsis.

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Conditions

The condition(s) this trial relates to.

iron deficiency anemia

As listed by the trial registrant

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

Iron deficiency anemia in preterm neaonates

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Ain shams university

    Cairo, Egypt