Clinical trial NCT02894866: Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy
Official title: Effect of Hyperbaric Oxygen Therapy on Neonatal Hypoxic-Ischemic Encephalopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypoxic-ischemic Encephalopathy
Keywords: hypoxic-ischemic encephalopathy
hyperbaric oxygen therapy
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 250
Sex: ALL
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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..

Detailed description: Hypoxic-ischemic encephalopathy (HIE) remains a major cause of neonatal death and long term disabilities. Data from animal studies have shown protective effects of hyperbaric oxygen therapy to impaired brain. Recently research priorities have moved from bench to bedside. Several studies have shown a trend for brain protection of hyperbaric oxygen therapy has emerged as a promising treatment for HIE. Therefore,the investigators organized a multi-centered randomized controlled trial of hyperbaric oxygen therapy in HIE newborn infants.

Eligibility criteria: * Inclusion Criteria:

  * 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
* Exclusion Criteria:

  * 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.

Primary outcomes:
measure: Number of Death or Moderate to Severe Disability Which is Graded According to Gross Motor Function Classification System （GMFCS）
timeFrame: 18 months of life
Secondary outcomes:
measure: Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities
timeFrame: 3 months of life
measure: Number of Infants with Brain Magnetic Resonance Imaging Abnormalities
timeFrame: 3 months of Lif
measure: Number of Infants with Brain-stem Auditory Evoked Potentials Abnormalities at 3 Months of Life
timeFrame: 3 months of life
measure: neonatal behavioral neurological assessment
timeFrame: 7,14 and 28 days after birth
measure: Bayley Scales of Infant Development
timeFrame: 6,12 and 18 months of life
measure: Gross Motor Function Classification System
timeFrame: 18 months of life
measure: Adverse Events That Are Related to Treatment
timeFrame: 3 months of life
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Maternity and Child Healthcare Hospital
state: Fujian
city: Guangzhou
country: China
facility: Nanfang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Zhujiang Hospital of Southern Medical University
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen Maternity and Child Healthcare Hospital
state: Guangdong
city: Shenzhen
country: China
facility: Shenzhen People's Hospital
state: Guangdong
city: Guangxi
country: China
facility: The Maternity and Child Healthcare Hospital of Guangxi Zhuang Autonomous Region
state: Guangxi
city: Changsha
country: China
facility: Hunan Children's hospital
state: Hunan
city: Jilin
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Chengdu
country: China
facility: Chengdu Women and Children's central hospital
state: Sichuan
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Weimin Huang, Doctor
role: STUDY_CHAIR
References: