Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy
Effect of Hyperbaric Oxygen Therapy on Neonatal Hypoxic-Ischemic Encephalopathy
1 other identifier
interventional
250
1 country
10
Brief Summary
The purpose of this study is to to evaluate the safety and efficacy of hyperbaric oxygen in term gestation newborn infants with hypoxic-ischemic encephalopathy..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2016
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 26, 2016
CompletedFirst Posted
Study publicly available on registry
September 9, 2016
CompletedStudy Start
First participant enrolled
October 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2021
CompletedApril 5, 2018
March 1, 2018
3.9 years
August 26, 2016
April 3, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Death or Moderate to Severe Disability Which is Graded According to Gross Motor Function Classification System （GMFCS）
Number of Death or Moderate to Severe Disability Which is Graded According to
18 months of life
Secondary Outcomes (7)
Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities
3 months of life
Number of Infants with Brain Magnetic Resonance Imaging Abnormalities
3 months of Lif
Number of Infants with Brain-stem Auditory Evoked Potentials Abnormalities at 3 Months of Life
3 months of life
neonatal behavioral neurological assessment
7,14 and 28 days after birth
Bayley Scales of Infant Development
6,12 and 18 months of life
- +2 more secondary outcomes
Study Arms (2)
hyperbaric oxygen
EXPERIMENTALNewborns with hypoxic ischemic encephalopathy treated with intensive care and hyperbaric oxygen
control
NO INTERVENTIONNewborns with hypoxic ischemic encephalopathy treated with intensive care only
Interventions
The hyperbaric oxygen treatment will be administered for 60 min in a baby hyperbaric oxygen chamber pressured with 100% oxygen to 1.5 to 1.8 atm absolute (ATA) and a constant oxygen flow was given to maintain the oxygen. concentration in the chamber at 80% or greater.The treatment will be administered once a day within 7 days after birth, 7 days is a course of treatment, at least for 4 courses.
Eligibility Criteria
You may qualify if:
- Newborn infants whose gestational age ≥37 weeks' gestation, weighing over 2500 g ;
- Acute perinatal event (e.g., late or variable decelerations, cord prolapse, cord rupture, uterine rupture, maternal trauma, hemorrhage, or cardiorespiratory arrest)
- With an Apgar score ≤ 3 at one minute and ≤5 at five minutes, and/or a potential of hydrogen of 7.0 or less or a base deficit of 16 mmol per liter or more in a sample of umbilical-cord blood or any blood during the first hour after birth.
- Having moderate-to-severe encephalopathy (indicated by lethargy, stupor, or coma) and either hypotonia, abnormal reflexes (including oculomotor or pupillary abnormalities), an absent or weak suck, or clinical seizures, and/or have abnormal background activity of at least 20 minutes' duration or seizures on amplitude integrated electroencephalography
You may not qualify if:
- A congenital and the hereditary disease, a chromosome abnormalities, and a congenital abnormality.
- During the acute phases of intracranial and (or) fundus hemorrhage. o
- Intracranial infection.
- Pneumothorax.
- Infants who have been received hypothermia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Xiamen Maternity and Child Healthcare Hospital
Xiamen, Fujian, 361003, China
Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, 510000, China
The Third Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
Shenzhen Maternity and Child Healthcare Hospital
Shenzhen, Guangdong, 518000, China
Shenzhen People's Hospital
Shenzhen, Guangdong, 518000, China
The Maternity and Child Healthcare Hospital of Guangxi Zhuang Autonomous Region
Guangxi, Guangxi, 530000, China
Hunan Children's hospital
Changsha, Hunan, 410007, China
The First Hospital of Jilin University
Jilin, Jilin, 130000, China
Chengdu Women and Children's central hospital
Chengdu, Sichuan, 610000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Weimin Huang, Doctor
Nanfang Hospital, Southern Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 26, 2016
First Posted
September 9, 2016
Study Start
October 1, 2016
Primary Completion
September 1, 2020
Study Completion
September 1, 2021
Last Updated
April 5, 2018
Record last verified: 2018-03
Data Sharing
- IPD Sharing
- Will not share