Status:
COMPLETED
Neuroprotective Effects of Hypothermia Combined With Inhaled Xenon Following Perinatal Asphyxia
Lead Sponsor:
Imperial College London
Collaborating Sponsors:
University College London Hospitals
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Hypoxic Ischaemic Encephalopathy
Eligibility:
All Genders
1-12 years
Phase:
NA
Brief Summary
This is a randomised controlled trial in newborn infants with perinatal asphyxial encephalopathy assessing whether a combination of hypothermia and inhaled xenon preserve cerebral metabolism and struc...
Detailed Description
The study hypothesis is that: Following perinatal asphyxia treatment with a combination of hypothermia and inhaled xenon preserves cerebral metabolism and structure. Following informed parental consen...
Eligibility Criteria
Inclusion
- Infants will be eligible for enrolment into the trial if each of the following criteria is fulfilled:
- Infants 36 to 43 weeks gestation with at least one of the following:
- Apgar score of \<5 at 10 minutes after birth;
- Continued need for resuscitation, including endotracheal or mask ventilation, at 10 minutes after birth;
- Acidosis defined as pH \<7.00 and/or base deficit \>15 mmol/L in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood).
- 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 HIE will be assessed by Thompson encephalopathy score, and modified Sarnat score.
- At least 30 minutes duration of amplitude integrated EEG (aEEG) recording that shows moderately abnormal or suppressed background aEEG activity or seizures
Exclusion
- If treatment with hypothermia is delayed beyond 6 hours, or infants are expected to be \>12 hours of age at the time of randomisation; Infants with ventilatory oxygen requirement \> 70%; Attending clinician considers infant not suitable to participate because of other serious congenital abnormalities, or the infant's condition appears terminal.
Key Trial Info
Start Date :
February 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2014
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT00934700
Start Date
February 1 2012
End Date
September 1 2014
Last Update
April 21 2022
Active Locations (1)
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1
Imperial College Academic Healthcare Trust
London, United Kingdom, W12 0HS