Hydrogen In Neonatal Encephalopathy (HIE) Trial
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
AgeUp to 2
SponsorBoston Children's Hospital
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Infants born ≥36 weeks gestation.
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)
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Hydrogen Gas (H2)
DrugPatients 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.
Treatment groups
54 Participants
are divided into 2 treatment groupsGroup A: Hydrogen Gas (H2) InterventionExperimental treatment 1 intervention
Group B: Standard of CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Hydrogen Gas Adminstration Safety
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.
Time frame
30 days post randomization2
Hydrogen Gas Adminstration Feasibility
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
Time frame
72 hours post randomizationSecondary outcomes
1
Evidence of Brain Injury on Clinically Ordered Imaging
Using brain imaging collected after therapeutic hypothermia has completed, we will assess if H2 therapy minimizes ischemic changes
Time frame
3-7 days post randomization2
Markers of Ischemic Injury
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.
Time frame
0, 1, 2, 3, and 4 days post randomization3
Survival
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.
Time frame
post-randomization through 6 months of age4
Neurodevelopmental Outcome
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.
Time frame
24-36 months of ageLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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