The CoolXenon Study

Completed

• Conditions: Topic: Neurological; Subtopic: Neurological (all Subtopics); Disease: Nervous system disorders; Injury, Occupational Diseases, Poisoning; Brain injury

• Registration Number: ISRCTN75602528
• Lead Sponsor: niversity Hospitals Bristol NHS Foundation Trust (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11-26
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

Infants will be eligible for xenon if the St Michael's standard inclusion criteria for cooling are met. Standard Hypothermia Treatment Criteria for 72 hours of cooling - all of criteria A, B, and C:

A: Infants greater than 36.0 weeks gestation (clinical assessment) with at least one of the following:
1. Apgar score of less than 5 at ten (10) minutes after birth
2. Continued need for resuscitation, including endotracheal or mask ventilation, at ten minutes after birth
3. Acidosis defined as either umbilical cord pH or any arterial, venous or capillary pH within 60 minutes of birth less than pH 7.00
4. Base deficit greater than or equal to 16 mmol/L in umbilical cord blood sample or any blood sample within 60 minutes of birth (arterial or venous blood)
If the infant meets criterion A then assess for neurological abnormality using criterion B and C (by trained personnel).

B: Moderate or severe encephalopathy as evidenced by:
1. Altered state of consciousness (reduced or absent responses or pathological irritability and hyper responsive
And at least one or more of the following:
2. Hypotonia
3. Abnormal reflexes including oculomotor or pupillary abnormalities
4. Absent or weak suck
5. Clinical seizures, as recorded by trained personnel

C: At least 30 minutes duration of amplitude integrated electroencephalography (aEEG) recording that shows abnormal background aEEG activity. The decision to cool is based on the worst section of the aEEG, not the best (al Naqeeb, et al, 1999) or seizures (clinical or electrical) thus meeting ONE of the following:
1. Normal background with some electrical seizure activity
2. Moderately abnormal activity (upper margin of trace greater than 10 µV and lower margin less than 5 µV)
3. Suppressed activity (upper margin of trace less than 10 µV and lower margin of trace less than 5 µV)
4. Definite seizure activity

Additional inclusion criteria for xenon:
Before being considered for additional inhaled xenon therapy via the breathing gas mixture, the infant would need to meet further additional entry criteria:
1. Intubated, ventilated, sedated, being cooled
2. Any seizures under control
3. Weight greater than 2.3 kg
4. No evidence of infection
5. Stable cardiovascular parameters - mean arterial pressure greater than 45mmHg
6. Oxygen requirement via mechanical ventilator less than 35%
7. Positive end expiratory pressure (PEEP) requirement less than 6 mmHg
8. Arterial pCO2 within the accepted range (4.5 - 6.5 kPa)
9. Postnatal age less than 18 hours, either sex
10. Major congenital abnormalities, imperforate anus and congenital abnormalities suggestive of chromosomal anomaly or other syndromes that include brain dysgenesis

Exclusion Criteria

1. Infants expected to be greater than 12 hours of age at the time of starting cooling treatment
2. Futility; where prognosis is considered to be hopeless, e.g. no cardiac output for 20 minutes
3. Failure to meet the additional inclusion criteria for xenon

Study & Design

• Study Type: Interventional
• Study Design: Not specified