Randomised outcome study of cooling therapy (standard treatment) versus inhaled xenon gas in combination with cooling, in babies at high risk of brain injury following poor condition at birth.

• Conditions: eonatal hypoxia-ischaemia (HI). There is no exact MedDRA term for this.The closest MedDRA terms matching this are neonatal asphyxia and neonatal hypoxia.; MedDRA version: 16.1Level: PTClassification code 10028923Term: Neonatal asphyxiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; MedDRA version: 16.1Level: HLTClassification code 10028946Term: Neonatal hypoxia and asphyxiaSystem Organ Class: 100000004868; MedDRA version: 16.1Level: PTClassification code 10050081Term: Neonatal hypoxiaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2013-004478-80-GB
• Lead Sponsor: niversity Hospital Bristol NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-04-04
• Last Update Posted: 7 April 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

Infants will be eligible for Xenon if the St Michael’s hospital standard inclusion criteria for cooling are met and additional inclusion criteria for Xenon administration are met.

St Michael’s hospital standard inclusion criteria for cooling
Standard Hypothermia Treatment Criteria for 72 hrs of cooling — all of criteria A, B, and C.
A: Infants = 36.0 weeks gestation (estimated or clinical assessment) with at least ONE of the following:
i.Apgar score of =5 at ten (10) minutes after birth
ii.Continued need for resuscitation, including tracheal or mask ventilation, at ten minutes after birth
iii.Acidosis defined as either umbilical cord pH or any arterial, venous or capillary pH within 60 minutes of birth less < 7.00
iv.Base deficit =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 any of the following:
i.Altered state of consciousness (reduced or absent responses or pathological irritability and hyper responsive and at least ONE or more of the following:
ii.Hypotonia
iii.Abnormal reflexes including oculomotor or pupillary abnormalities
iv.Absent or weak suck
v.Clinical seizures, as recorded by trained personnel
AND
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 30 min section of the aEEG, not the best, or seizures (clinical or electrical) thus meeting ONE of the following:
i.Normal background with some (> 5 min) electrical seizure activity
ii.Moderately abnormal activity (upper margin of trace >10µV and lower margin <5µV)
iii.Suppressed activity (upper margin of trace <10µV and lower margin of trace <5µV)
iv.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 (all must be met):
i.Intubated, ventilated, sedated, being cooled.
ii.=5 hours old
iii.Any seizures under control.
iv.Weight > 2nd centile for gestational age
v.Stable cardiovascular parameters; Mean arterial pressure >40mmHg.
vi.Oxygen requirement via mechanical ventilator < 40%.
vii.Positive End Expiratory Pressure (PEEP) requirement = 8cm H2O
viii.Arterial/capillary/venous pCO2 <7.0kPa (ideally arterial). Venous can be higher if peri-arrest and tissues have been very recently Ischaemic
ix.Postnatal age =5 hours
x.Absence of major congenital abnormalities, imperforate anus and in particular any bowel obstruction, congenital abnormalities suggestive of chromosomal anomaly or other syndromes that include brain dysgenesis. Congenital syndromes affecting the brain should be excluded when diagnosed.

Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

Exclusion criteria for cooling in the CoolXenon3 study
a.Infants expected to be greater than 3 hours of age at the time of starting cooling treatment.
b.Futility. Where prognosis is considered to be hopeless e.g. no cardiac output for 20 minutes.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified