Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy

Hypoxic-ischemic Encephalopathy Clinical Trial

Official title:

Effect of Hyperbaric Oxygen Therapy on Neonatal Hypoxic-Ischemic Encephalopathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02894866
• Other study ID #: NFEC-2016-097
• Status: Recruiting
• Phase: N/A
• First received: August 26, 2016
• Last updated: April 3, 2018
• Start date: October 2016
• Est. completion date: September 2021

Study information

• Verified date: March 2018
• Source: Nanfang Hospital of Southern Medical University
• Contact: Lishan Guo, Doctor
• Phone: +86 13580538496
• Email: nfyygls[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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..

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: September 2021
• Est. primary completion date: September 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 7 Days

Eligibility

• 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.

Related Conditions & MeSH terms

• Brain Diseases
• Brain Ischemia
• Hypoxia
• Hypoxia-Ischemia, Brain
• Hypoxic-ischemic Encephalopathy
• Ischemia

Intervention

Device:
• hyperbaric oxygen
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.

Locations

Country	Name	City	State
China	Hunan Children's hospital	Changsha	Hunan
China	Chengdu Women and Children's central hospital	Chengdu	Sichuan
China	The Maternity and Child Healthcare Hospital of Guangxi Zhuang Autonomous Region	Guangxi	Guangxi
China	Nanfang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The First Hospital of Jilin University	Jilin	Jilin
China	Shenzhen Maternity and Child Healthcare Hospital	Shenzhen	Guangdong
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	Xiamen Maternity and Child Healthcare Hospital	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities	Number of Infants with abnormal ambulatory electroencephalography monitoring	3 months of life
Secondary	Number of Infants with Brain Magnetic Resonance Imaging Abnormalities	Number of Infants with Brain Magnetic Resonance Imaging Abnormalities	3 months of Lif
Secondary	Number of Infants with Brain-stem Auditory Evoked Potentials Abnormalities at 3 Months of Life	Number of Infants with Brain-stem Auditory Evoked Potentials	3 months of life
Secondary	neonatal behavioral neurological assessment	neonatal behavioral neurological assessment	7,14 and 28 days after birth
Secondary	Bayley Scales of Infant Development	Bayley Scales of Infant Development	6,12 and 18 months of life
Secondary	Gross Motor Function Classification System	Gross Motor Function Classification System	18 months of life
Secondary	Adverse Events That Are Related to Treatment	fundus examination by ophthalmofunduscope to evaluate retinopathy of prematurity,chest radiograph to evaluate pneumothorax, and monitoring vital signs by neonatal monitor	3 months of life