europrotective effects of hypothermia combined with inhaled xenon following perinatal asphyxia

Not Applicable

Completed

• Conditions: Perinatal asphyxia with hypoxic-ischaemic encephalopathy; Pregnancy and Childbirth; Birth asphyxia

• Registration Number: ISRCTN08886155
• Lead Sponsor: Imperial College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-30
• Last Update Posted: 18 April 2017

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 92

Inclusion Criteria

1. Infants 36 to 43 weeks gestation (either sex) with at least one of the following:
1.1. Apgar score of less than 5 at 10 minutes after birth
1.2. Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth
1.3. Acidosis defined as pH less than 7.00 and/or base deficit x 16 mmol/L in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood)
2. Moderate to severe encephalopathy consisting of altered state of consciousness (reduced or absent response to stimulation) and hypotonia, and abnormal primitive reflexes (weak or absent suck or Moro response). Clinical severity of hypoxic-ischaemic encephalopathy (HIE) will be assessed by Thompson encephalopathy score, and modified Sarnat score
3. At least 30 minutes duration of amplitude integrated EEG (aEEG) recording that shows moderately abnormal or suppressed background aEEG activity or seizures

Exclusion Criteria

1. If treatment with hypothermia is delayed beyond 6 hours, or infants are expected to be greater than 12 hours of age at the time of randomisation
2. Infants with ventilatory oxygen requirement greater than 70%
3. Attending clinician considers infant not suitable to participate because of other serious congenital abnormalities, or the infant's condition appears terminal

Study & Design

• Study Type: Interventional
• Study Design: Not specified