Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy

Last updated: April 3, 2018
Sponsor: Nanfang Hospital of Southern Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Cerebral Ischemia

Stroke

Cerebral Palsy

Treatment

N/A

Clinical Study ID

NCT02894866
NFEC-2016-097
  • Ages < 7
  • All Genders

Study 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..

Eligibility Criteria

Inclusion

  • 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, cordrupture, uterine rupture, maternal trauma, hemorrhage, or cardiorespiratoryarrest)

  • With an Apgar score ≤ 3 at one minute and ≤5 at five minutes, and/or a potentialof hydrogen of 7.0 or less or a base deficit of 16 mmol per liter or more in asample 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 pupillaryabnormalities), an absent or weak suck, or clinical seizures, and/or haveabnormal background activity of at least 20 minutes' duration or seizures onamplitude integrated electroencephalography

Exclusion

  • Exclusion Criteria:

  • A congenital and the hereditary disease, a chromosome abnormalities, and acongenital abnormality.

  • During the acute phases of intracranial and (or) fundus hemorrhage. o

  • Intracranial infection.

  • Pneumothorax.

  • Infants who have been received hypothermia.

Study Design

Total Participants: 250
Study Start date:
October 01, 2016
Estimated Completion Date:
September 30, 2021

Study 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.

Connect with a study center

  • Xiamen Maternity and Child Healthcare Hospital

    Xiamen, Fujian 361003
    China

    Active - Recruiting

  • Xiamen Maternity and Child Healthcare Hospital

    Xiamen Shi, Fujian 361003
    China

    Site Not Available

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • The Third Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong 510000
    China

    Active - Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong 510280
    China

    Active - Recruiting

  • Shenzhen Maternity and Child Healthcare Hospital

    Shenzhen, Guangdong 518000
    China

    Site Not Available

  • Shenzhen People's Hospital

    Shenzhen, Guangdong 518000
    China

    Active - Recruiting

  • The Maternity and Child Healthcare Hospital of Guangxi Zhuang Autonomous Region

    Guangxi, Guangxi 530000
    China

    Site Not Available

  • Wuhan Women and Children medical care center

    Wuhan, Hubei 430000
    China

    Site Not Available

  • Hunan Children's hospital

    Changsha, Hunan 410007
    China

    Active - Recruiting

  • Xiangya Hospital Central South University

    Xiangya, Hunan 410008
    China

    Site Not Available

  • The First Hospital of Jilin University

    Jilin, Jilin 130000
    China

    Active - Recruiting

  • Chengdu Women and Children's central hospital

    Chengdu, Sichuan 610000
    China

    Active - Recruiting

  • Tianjin Children's hospital

    Tianjin, Tianjin 300000
    China

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.