EUCTR2007-002567-27-DE进行中（未招募）不适用
CLINICAL PHASE III MULTI-CENTRIC, DOUBLE-BLIND, DOUBLE DUMMY, RANDOMISED STUDY TO COMPARE SAFETY AND EFFICACY OF DOPRAM® (DOXAPRAM HYDROCHLORIDE) TO CAFEINE COOPER (CAFFEINE CITRATE) IN THE TREATMENT OF APNOEIC PREMATURE BABIES
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •- premature infants with a corrected gestational age of 25;0 to 30;6 weeks confirmed by early ultrasound done before the 14th week of gestation or calculated from the first day of the last menstruation.
- •- infant has
- •- - either > 3 apnoeic episodes/h* for at least 2 hours
- •- - and/or > 1 severe apnoea requiring ambubagging within 8 hours
- •- - written informed consent of the parents prior to enrolment of their infant into the study.
- •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
- •participation of the mother in another study with any investigational drug within the last 30 days.
- •state after maternal drug consumption
- •treatment with doxapram or caffeine prior to entering the study.
- •concomitant medications or procedures which could interfere with the study or with the study medication (see appendix).
- •medication with potential cardiotoxic side effects (according to SmPC)
- •clinical sepsis, any other serious disease (like infections, lung diseases, metabolic disorders etc.) or other reasons (hypoglycemia, hypo- or hyperthermia etc.) that may be the cause of the apnoeas observed and could interfere with the performance of the study.
- •severe congenital abnormalities as listed in the CRIB Score and refined by the Neo-AG MV (see appendix).
- •intracranial haemorrhage grade 3 or 4, convulsions, cystic periventricular leukomalacia, spontaneous intestinal perforation, or necrotising enterocolitis prior to starting treatment.
- •cardiac arrhythmia (extrasystoles or AV block) or heart failure (necessity of a cardioactive drug with catecholamines or diuretics) prior to starting treatment.
- •QTc > 0.44 seconds at any time during treatment.
- •hypertension (normal values according to Roos [2003], upper limit according to age and current weight (mean value + 2x standard deviation), measured at least 3 times during an 8 h period).
- •any other conditions or therapy which, in the opinion of the physician in charge for the infant, might impose an additional risk to the infant.
研究者
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