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Iron overload linked to blindness risk in preemies?

NCT ID NCT05133999

Knowledge-focused Sponsor: Assistance Publique - Hôpitaux de Paris 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at 175 premature babies to see if high iron levels in their blood during the first month of life are linked to a serious eye condition called retinopathy of prematurity (ROP). Researchers measured iron-related markers and tracked which babies developed ROP. The goal was to better understand the role of iron in this disease, not to test a new treatment.

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

175 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 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.

Who is studied

Preterm infants born at \<31 weeks' PMA or ≤1250 g of birth weight

Ages

24 to 31 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: * All infants born at \<31 week's post-menstrual age (PMA) or ≤1250g of birthweight * Admitted at two neonatology departments (level III) from birth * With non-opposition consent of two parents Exclusion Criteria: * Congenital malformation * Life-threatening condition (not expected to survive more than a few days) * Absence of health care protection.

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Conditions

The condition(s) this trial relates to.

Premature Birth retinal disorder retinopathy of prematurity

As listed by the trial registrant

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

Retinopathy of prematurity

Contacts and locations

Locations

  • Ophtalmology department _ Necker Enfants Malades Hospital

    Paris, 75015, France

  • Pediatrics and neonatal intensive care department - Cochin hospital - Port Royal Maternity

    Paris, 75014, France

  • Pediatrics and noenatal intensive care department - Necker-Enfants Malades Hospital

    Paris, 75015, France

More trials for these conditions

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