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Could a hormone shot save newborns from brain damage?

NCT ID NCT01732146

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This phase 3 study tested whether high doses of erythropoietin, a hormone that boosts red blood cell production, could improve survival and brain development in full-term newborns who suffered oxygen deprivation at birth. All 120 babies also received standard cooling therapy. The goal was to see if adding erythropoietin could reduce the risk of long-term disabilities like motor, vision, or hearing problems.

What this could mean

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

Active substance
erythropoietin (a hormone that stimulates red blood cell production)
What this could lead to
If it works, this could offer a new treatment to reduce brain damage and disability in newborns who suffered oxygen loss at birth.
What could go wrong
This trial is completed but results are not yet widely confirmed. The treatment is given alongside cooling therapy, and high doses may have side effects. It may not work for all babies.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

120 people

The number who actually took part.

Started

Mar 2013

Finished

Feb 2017

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

Up to 12 hours

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: * Term or near-term newborn (\> = 36 weeks gestational age) * Moderate to severe encephalopathy * undergoing moderate controlled hypothermia started within 6 hours after delivery : rectal or esophageal temperature maintained at 33.5 ° C + / - 0.5 ° C before H6 * Beneficiary of social security plan * Informed consent parental authority Exclusion Criteria: * Impossibility of getting controlled hypothermia before H6 * Infant older than 12 hours of age * Chromosomal or significant congenital abnormality * Predictable surgery in the first 3 days of life * Uncontrolled collapse * Haemorrhagic syndrome unchecked * Head trauma with or without skull fracture

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia perinatal asphyxia

As listed by the trial registrant

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

Hypoxic-ischemic encephalopathy

Contacts and locations

Locations

  • Cochin Hospital

    Paris, 75014, France

More trials for these conditions

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