EUCTR2009-014260-19-GB进行中（未招募）1 期
A feasibility study of adding xenon to cooling therapy in babies at high risk of brain injury following poor condition at birth - Feasibility study of adding xenon to cooling therapy in neonates
niversity Hospital Bristol NHS Foundation Trust0 个研究点目标入组 14 人开始时间: 2010年3月17日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 14
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
入选标准
- •Infants will be eligible for xenon if the St Michael’s standard inclusion criteria for cooling are met
- •Standard Hypothermia Treatment Criteria for 72 hrs of cooling — all of criteria A, B, and C.
- •A Infants > 36.0 weeks gestation (clinical assessment) with at least ONE of the following:
- •1 Apgar score of <5 at ten (10) minutes after birth
- •2 Continued need for resuscitation, including endotracheal or mask ventilation, at ten minutes after birth
- •3Acidosis defined as either umbilical cord pH or any arterial, venous or capillary pH within 60 minutes of birth less than pH 7.00
- •4Base 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):
- •BModerate or Severe encephalopathy as evidenced by any of the following --
- •1Altered state of consciousness (reduced or absent responses or pathological irritability and hyper responsive and at least ONE or more of the following:
- •3Abnormal reflexes including oculomotor or pupillary abnormalities
- •4Absent or weak suck
- •5Clinical seizures, as recorded by trained personnel
- •CAt 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:
- •1Normal background with some electrical seizure activity
- •2Moderately abnormal activity (upper margin of trace >10µV and lower margin <5µV)
- •3Suppressed activity (upper margin of trace <10µV and lower margin of trace <5µV)
- •4Definite 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 > 2.3 kg.
- •4)No evidence of infection.
- •5)Stable cardiovascular parameters; Mean arterial pressure >45mmHg.
- •6)Oxygen requirement via mechanical ventilator < 35%.
- •7)Positive End Expiratory Pressure (PEEP) requirement < 6mmHg
- •8)Arterial pCO2 within the accepted range (4.5-6.5 kPa)
- •9)Postnatal age <18 hours
- •10)Major congenital abnormalities, imperforate anus and congenital abnormalities suggestive of chromosomal anomaly or other syndromes that include brain dysgenesis.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria for cooling
- •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.
- •Failure to meet the 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 > 2.3 kg.
- •4)No evidence of infection.
- •5)Stable cardiovascular parameters; Mean arterial pressure >45mmHg.
- •6)Oxygen requirement via mechanical ventilator < 35%.
- •7)Positive End Expiratory Pressure (PEEP) requirement < 6mmHg
- •8)Arterial pCO2 within the accepted range (4.5-6.5 kPa)
- •9)Postnatal age <18 hours
- •10)Major congenital abnormalities, imperforate anus and congenital abnormalities suggestive of chromosomal anomaly or other syndromes that include brain dysgenesis.
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