Hypoxic-ischemic Encephalopathy
Conditions
Keywords
hypoxic-ischemic encephalopathy, hyperbaric oxygen therapy
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.
Interventions
DEVICEhyperbaric 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.
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 7 Days
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Death or Moderate to Severe Disability Which is Graded According to Gross Motor Function Classification System （GMFCS） | 18 months of life | Number of Death or Moderate to Severe Disability Which is Graded According to |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Infants with Brain Magnetic Resonance Imaging Abnormalities | 3 months of Lif | Number of Infants with Brain Magnetic Resonance Imaging Abnormalities |
| Number of Infants with Brain-stem Auditory Evoked Potentials Abnormalities at 3 Months of Life | 3 months of life | Number of Infants with Brain-stem Auditory Evoked Potentials |
| neonatal behavioral neurological assessment | 7,14 and 28 days after birth | neonatal behavioral neurological assessment |
| Number of Infants with abnormal ambulatory electroencephalography monitoring Abnormalities | 3 months of life | Number of Infants with abnormal ambulatory electroencephalography monitoring |
| Gross Motor Function Classification System | 18 months of life | Gross Motor Function Classification System |
| Adverse Events That Are Related to Treatment | 3 months of life | fundus examination by ophthalmofunduscope to evaluate retinopathy of prematurity，chest radiograph to evaluate pneumothorax, and monitoring vital signs by neonatal monitor |
| Bayley Scales of Infant Development | 6,12 and 18 months of life | Bayley Scales of Infant Development |
Countries
China
Contacts
Primary ContactLishan Guo, Doctor
Backup ContactMing Yang, Master
Outcome results
None listed