EUCTR2013-004478-80-GB进行中（未招募）不适用
XENON AND COOLING THERAPY IN BABIES AT HIGH RISK OF BRAIN INJURY FOLLOWING POOR CONDITION AT BIRTH: A RANDOMISED OUTCOME STUDY (COOLXENON3 STUDY) - CoolXenon3
niversity Hospital Bristol NHS Foundation Trust0 个研究点目标入组 52 人开始时间: 2014年4月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
- •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
排除标准
- •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.
研究者
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