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Could hydrogen gas help protect newborn brains? early trial launches

NCT ID NCT07411911

Disease control Sponsor: Boston Children's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests whether adding hydrogen gas to standard cooling therapy is safe and feasible for newborns who suffered brain injury from lack of oxygen at birth (HIE). About 54 infants will be randomly assigned to receive either standard cooling alone or cooling plus 2% hydrogen gas through their breathing support for 72 hours. The main goals are to check for side effects and see if the hydrogen can be given reliably, not yet to measure long-term benefits.

What this could mean

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

Active substance
Hydrogen gas (2% mixed with breathing gases)
What this could lead to
If safe and feasible, this could pave the way for a larger trial to see if hydrogen gas helps reduce brain damage in newborns with HIE.
What could go wrong
This is a very early Phase 1 safety trial with only 54 infants. It is not designed to prove whether hydrogen actually improves outcomes, and the treatment is added to standard cooling, not replacing it.

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 54 people

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

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Mar 2031

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

Up to 2 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: 1. Infants born ≥36 weeks gestation. 2. Any one of the following: 1. sentinel event prior to delivery, such as uterine rupture, profound fetal bradycardia, or cord prolapse 2. low Apgar scores (≤ 5 at 10 minutes of life) 3. prolonged resuscitation at birth (chest compressions and/or intubation and/or mask ventilation at 10 minutes) 4. severe acidosis (pH \< 7.0 from cord or neonate blood gas within 60 minutes of birth) 5. abnormal base excess (≤ -16 mEq/L from cord gas or neonate blood gas within 60 minutes of birth) 3. Moderate or severe encephalopathy present in the first 2 hours of life. 4. Intubated and mechanically ventilated at the time of enrollment. Exclusion Criteria: 1. Enrollment in the opt-out program. 2. Presence of known cyanotic congenital heart disease. 3. Presence of known or suspected genetic/chromosomal syndrome or multiple congenital anomalies. 4. Presence of known congenital malformation that is expected to require urgent surgical intervention in the neonatal period, including congenital diaphragmatic hernia (CDH), gastroschisis, omphalocele, intestinal atresia, or imperforate anus. 5. Presence of antenatally diagnosed central nervous system malformation, including hemorrhage, hydrocephalus, or structural anomaly of the brain (eg. polymicrogyria). 6. Need for high frequency ventilation (HFV) at time of enrollment. 7. Patients receiving respiratory support via Drager Babylog ventilators. 8. Study enrollment and randomization after 2 hours of age

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Conditions

The condition(s) this trial relates to.

brain hypoxia - ischemia brain injury perinatal asphyxia

As listed by the trial registrant

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

HIE Hypoxic-ischemic encephalopathy

How to take part

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  1. The official record

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    Open the record ↗

  2. A doctor treating you

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