Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Hypoxic-ischemic Encephalopathy

Treatments: Device: hyperbaric oxygen

Study type: Interventional

Funder types: Other

Identifiers

NCT02894866

NFEC-2016-097

Details and patient eligibility

About

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..

Full 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.

Enrollment: 250 estimated patients

Sex: All

Ages: Under 7 days old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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250 participants in 2 patient groups

hyperbaric oxygen

Experimental group

Description:

Newborns with hypoxic ischemic encephalopathy treated with intensive care and hyperbaric oxygen

Treatment:

Device: hyperbaric oxygen

control

No Intervention group

Description:

Newborns with hypoxic ischemic encephalopathy treated with intensive care only