Investigation of the Optimal Cooling period for hypothermic treatment of Hypoxic Ischemic Encephalopathy (HIE) in term neonates (OCHIE)

Not Applicable

Recruiting

• Conditions: Hypoxic Ischemic Encephalopathy; Neurological - Other neurological disorders; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12614000728639
• Lead Sponsor: Mercy Hospital for Women

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Near-term or term infants born at 36 weeks' gestation or more with birth weight of >1.8kgs that have had hypothermia treatment started within 6 hours of birth because they have been clinically assessed and deemed suitable for the treatment because there was:
* Evidence of acute event around the time of birth Apgar
score of 5 or less at 10 minutes after birth, severe acidosis, defined as pH level of less than 7 or base deficit of 16 mmol/L or less (cord blood or any blood gas obtained within 1 h of birth), continued need for resuscitation at 10 minutes after birth and
* Evidence of moderate to severe encephalopathy at birth - clinically determined (at least 3 of the following:
lethargy, stupor, or coma; abnormal tone or posture; abnormal reflexes [suck, grasp, Moro, gag, stretch reflexes];
decreased or absent spontaneous activity; autonomic dysfunction [including bradycardia, abnormal pupils,
apneas]; and clinical evidence of seizures, moderately or severely abnormal amplitudeintegrated electroencephalography (aEEG) background or seizures (CoolCap and TOBY)

Exclusion Criteria

Less than 36 weeks gestation or hypothermia treatment not initiated within 6 hours of birth.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
aEEG activity - measured as the duration of abnormal activity as a percentage of time in relation to normal activity, and number and duration of seizures[0-4 days of age (before, during cooling and re-warming and immediately after treatment)];Resistance Index (RI) as measured in the anterior and middle cerebral arteries significantly lower (more than one standard deviation) lower than in normal neonates[0-5 days of age (during and immediately following hypothermia treatment).]

Secondary Outcome Measures

Name	Time	Method
Severe disability as defined as motor and/or cognitive delay as determined by Paediatrician at 2 year developmental review. [2 years of age]