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NCT Number: NCT07411911

Hydrogen In Neonatal Encephalopathy (HIE) Trial

Despite advances in neonatal care, moderate-to-severe acute perinatal HIE in late preterm and term infants remains a cause of mortality, neurological injury, and long-term neurodevelopmental disability. The current standard of care includes therapeutic hypothermia for 72 hours, but 40-50% of infants will die or suffer significant neurodevelopmental impairment. It has been shown that administration of hydrogen gas (H2) significantly diminishes ischemic injury in swine, and that H2 administration at the dose and duration proposed herein is well-tolerated in healthy adults. The purpose of this project is to test the feasibility and safety of H2 administration as an adjunct to therapeutic hypothermia in infants with HIE. Under exemption from informed consent, infants with severe, acute brain injury at birth will be randomized to standard therapy with or without the administration of 2% hydrogen in gases administered via the ventilator, non-invasive ventilation, or nasal cannula for 72 hours.

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Key information

Conditions

HIE Brain Diseases Brain Injuries Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Craniocerebral Trauma Hypoxia Hypoxia, Brain Hypoxia-Ischemia, Brain Hypoxic-Ischemic Encephalopathy Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Respiratory Trauma, Nervous System Vascular Diseases Wounds and Injuries

Age range

Up to 2 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Infants born ≥36 weeks gestation.
  • Any one of the following:
  • sentinel event prior to delivery, such as uterine rupture, profound fetal bradycardia, or cord prolapse
  • low Apgar scores (≤ 5 at 10 minutes of life)
  • prolonged resuscitation at birth (chest compressions and/or intubation and/or mask ventilation at 10 minutes)
  • severe acidosis (pH < 7.0 from cord or neonate blood gas within 60 minutes of birth)
  • abnormal base excess (≤ -16 mEq/L from cord gas or neonate blood gas within 60 minutes of birth)
  • Moderate or severe encephalopathy present in the first 2 hours of life.
  • Intubated and mechanically ventilated at the time of enrollment.

Exclusion criteria

  • Enrollment in the opt-out program.
  • Presence of known cyanotic congenital heart disease.
  • Presence of known or suspected genetic/chromosomal syndrome or multiple congenital anomalies.
  • 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.
  • Presence of antenatally diagnosed central nervous system malformation, including hemorrhage, hydrocephalus, or structural anomaly of the brain (eg. polymicrogyria).
  • Need for high frequency ventilation (HFV) at time of enrollment.
  • Patients receiving respiratory support via Drager Babylog ventilators.
  • Study enrollment and randomization after 2 hours of age

Treatment and study plan

Hydrogen Gas (H2)

Drug

Patients randomized to the hydrogen group will receive 2% hydrogen gas incorporated into all gas mixtures for 72 hours. The hydrogen gas will be administered via the ventilator, non-invasive ventilation, or nasal cannula.

Primary outcomes

  1. Hydrogen Gas Adminstration Safety

    Time frame: 30 days post randomization

    The incidence rate of Study AEs per day during the first 30 days post-randomization that have been classified as treatment-related or possibly treatment-related will be tracked.

  2. Hydrogen Gas Adminstration Feasibility

    Time frame: 72 hours post randomization

    To establish the feasibility of H2 administration in infants with HIE, we will compute the percentage of the first 72 hours (starting at the time of randomization) in which H2 gas was administered

Secondary outcomes

  1. Evidence of Brain Injury on Clinically Ordered Imaging

    Time frame: 3-7 days post randomization

    Using brain imaging collected after therapeutic hypothermia has completed, we will assess if H2 therapy minimizes ischemic changes

  2. Markers of Ischemic Injury

    Time frame: 0, 1, 2, 3, and 4 days post randomization

    Clinically ordered laboratory values will be analyzed in order to explore whether H2 therapy diminishes changes in routine laboratory markers of ischemic injury after HIE.

  3. Survival

    Time frame: post-randomization through 6 months of age

    Participant survival to hospital discharge, as well as NICU and hospital lengths of stay will be tracked in order to assess whether H2 therapy improves overall survival rate.

  4. Neurodevelopmental Outcome

    Time frame: 24-36 months of age

    The Bayley Scales of Infant and Toddler Development-4 (Bayley-4) will be used to explore whether H2 therapy improves neurodevelopmental outcome. Neurodevelopmental impairment Bayley-4 cognitive or motor score of less than 90.

Study contacts

Contact information is provided by the study sponsor or research team.

Rylee Kerper, MPH

CONTACT

[email protected]

617-919-7355

Vanessa Young, MS, BA, RN

CONTACT

[email protected]

617-355-8330

Sponsors and collaborators

Lead sponsor

Boston Children's Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2031
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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