Clinical Trial: Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Effect of Hyperbaric Oxygen Therapy on Neonatal Hypoxic-Ischemic Encephalopathy

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 Summary: 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.
Sponsor: Nanfang Hospital of Southern Medical University

Current Primary Outcome: Number of Death or Moderate to Severe Disability Which is Graded According to Gross Motor Function Classification System （GMFCS） [ Time Frame: 18 months of life ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Number of Infants with aEEG Abnormalities [ Time Frame: 3 months of life ]
  • Number of Infants with Brain Magnetic Resonance Imaging （MRI） Abnormalities [ Time Frame: 3 months of Lif ]
  • Number of Infants with Brain-stem Auditory Evoked Potentials (BAEP) Abnormalities at 3 Months of Life [ Time Frame: 3 months of life ]
  • neonatal behavioral neurological assessment （NBNA） [ Time Frame: 7,14 and 28 days after birth ]
  • Bayley Scales of Infant Development （BSID） [ Time Frame: 6,12 and 18 months of life ]
  • Gross Motor Function Classification System （GMFCS） [ Time Frame: 18 months of life ]
  • Adverse Events That Are Related to Treatment [ Time Frame: 3 months of life ]
    fundus examination by ophthalmofundoscope to evaluate retinopathy of prematurity，chest radiograph to evaluate pneumothorax, and monitoring vital signs by neonatal monitor


Original Secondary Outcome: Same as current

Information By: Nanfang Hospital of Southern Medical University

Dates:
Date Received: August 26, 2016
Date Started: October 2016
Date Completion: September 2021
Last Updated: November 7, 2016
Last Verified: August 2016