EUCTR2011-005696-17-ES进行中（未招募）不适用
Multicenter, randomized, blinded clinical study comparing early use of total body moderate hypothermia plus topiramate or placebo in asphyxiated newborn infants evolving to moderate-to-severe hypoxic ischemic encephalopathy
Instituto de Investigacion Sanitaria La Fe0 个研究点开始时间: 2013年3月21日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •Signed informed consent by parents or legal guardians.
- •? Term near term gestation (?36weeks)
- •? Birth weight ? 2000g
- •? Significant moderate to severe Hypoxic Ischemic Encephalopathy, estimated with the modified Sarnat classification (see Annex 2)
- •? Evident signs of asphyxia during labor: meconium and/or alteration of fetal heart rate.
- •? Inborn in referral center or arrival to referral center within the acceptable timeframe for initiating hypothermia (6 hours after birth).
- •? The patient must meet at least, one criteria of A and one of B:
- •A. Existence of perinatal data compatible with peripartum hypoxic ischemia:
- •- Non-reassuring fetal status during fetal monitoring
- •- Pathological scalp pH (<7.2)
- •- Hypoxic-ischemic sentinel signs (cord prolapse, placenta abruptio, uterine rupture, severe fetal hemorrhage); dystocia during delivery.
- •B. Objective status of perinatal affectation:
- •- Apgar score ? 5 at 5 minutes after birth
- •- Need of resuscitation with positive pressure ventilation (with mask or E.T.) at 10 minutes from birth.
- •pH ? 7 estimated at worse gasometry during the first 60 minutes (cordon, arterial, venous or capilar blood)
- •- Base Deficit (BE) ? 16 mmol/L estimated at worse gasometry during the first 60 minutes (cordon, arterial, venous or capilar blood)
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 152
- •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
- •? Gestational age <36weeks? gestation
- •? Birth weight < 2000g
- •? Any pathology requiring surgery prior to discharge
- •? Major congenital malformations
- •? Imminent death
- •? Chromosomopathies
- •? Rejection to participate or to sign inform consent
- •? Erroneous or impossibility for randomization
- •? Incapability of initiating active or passive hypothermia (rectal temperature ? 34ºC) within the 6 hours timeframe
- •? Use of another investigational agent
研究者
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