---
title: Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy
nct_id: NCT02894866
overall_status: UNKNOWN
phase: NA
sponsor: Nanfang Hospital, Southern Medical University
study_type: INTERVENTIONAL
primary_condition: Hypoxic-ischemic Encephalopathy
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02894866.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02894866"
ct_last_update_post_date: 2018-04-05
last_seen_at: "2026-05-12T06:22:26.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Hyperbaric Oxygen Therapy Improves Outcome of Hypoxic-Ischemic Encephalopathy

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

**NCT ID:** [NCT02894866](https://clinicaltrials.gov/study/NCT02894866)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 250
- **Lead Sponsor:** Nanfang Hospital, Southern Medical University
- **Conditions:** Hypoxic-ischemic Encephalopathy
- **Start Date:** 2016-10
- **Completion Date:** 2021-09
- **CT.gov Last Update:** 2018-04-05

## 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 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.

## Eligibility

- **Maximum age:** 7 Days
- **Sex:** ALL
- **Healthy Volunteers:** No

```
* 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.
```

## Arms

- **hyperbaric oxygen** (EXPERIMENTAL) — Newborns with hypoxic ischemic encephalopathy treated with intensive care and hyperbaric oxygen
- **control** (NO_INTERVENTION) — Newborns with hypoxic ischemic encephalopathy treated with intensive care only

## Interventions

- **hyperbaric oxygen** (DEVICE) — 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.

## Primary Outcomes

- **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)_ — Number of Death or Moderate to Severe Disability Which is Graded According to

## Secondary Outcomes

- **Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities** _(time frame: 3 months of life)_
- **Number of Infants with Brain Magnetic Resonance Imaging Abnormalities** _(time frame: 3 months of Lif)_
- **Number of Infants with Brain-stem Auditory Evoked Potentials Abnormalities at 3 Months of Life** _(time frame: 3 months of life)_
- **neonatal behavioral neurological assessment** _(time frame: 7,14 and 28 days after birth)_
- **Bayley Scales of Infant Development** _(time frame: 6,12 and 18 months of life)_
- **Gross Motor Function Classification System** _(time frame: 18 months of life)_
- **Adverse Events That Are Related to Treatment** _(time frame: 3 months of life)_

## Locations (10)

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.xiamen maternity and child healthcare hospital|xiamen|fujian|china` — added _(2026-05-12)_
- `locations.nanfang hospital of southern medical university|guangzhou|guangdong|china` — added _(2026-05-12)_
- `locations.the third affiliated hospital of guangzhou medical university|guangzhou|guangdong|china` — added _(2026-05-12)_
- `locations.zhujiang hospital of southern medical university|guangzhou|guangdong|china` — added _(2026-05-12)_
- `locations.shenzhen maternity and child healthcare hospital|shenzhen|guangdong|china` — added _(2026-05-12)_
- `locations.shenzhen people's hospital|shenzhen|guangdong|china` — added _(2026-05-12)_
- `locations.the maternity and child healthcare hospital of guangxi zhuang autonomous region|guangxi|guangxi|china` — added _(2026-05-12)_
- `locations.hunan children's hospital|changsha|hunan|china` — added _(2026-05-12)_
- `locations.the first hospital of jilin university|jilin|jilin|china` — added _(2026-05-12)_
- `locations.chengdu women and children's central hospital|chengdu|sichuan|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT02894866*  
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