NCT02894866

Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy

Effect of Hyperbaric Oxygen Therapy on Neonatal Hypoxic-Ischemic Encephalopathy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 7 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Hypoxic-ischemic Encephalopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-01
• Primary completion: 2020-09-01
• Completion: 2021-09-01
• First posted: 2016-09-09
• Last updated: 2018-04-05

Locations

10 sites across 1 country: China