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
- Conditions
- Premature infants with a corrected gestational age of 250 to 306 weeks with a immature central nervous system resulting in frequent apnoeic episodes
- Registration Number
- EUCTR2007-002567-27-DE
- Lead Sponsor
- RIEMSER Arzneimittel AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
• 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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Evaluation of the efficacy and safety of Dopram® (test drug) in<br>comparison to Cafeine Cooper (reference drug, authorised in France)<br>in the treatment of apnoea in premature infants with the aim to<br>investigate the equivalence (non-inferiority) of Dopram®;Secondary Objective: ;Primary end point(s): primary variable under consideration is the rate of patients with<br>success” under therapy, where success” is defined as at least a 50%<br>reduction in apnoea episodes, during the second 24 hours after start of<br>treatment compared to the number of apnoea episodes during the last<br>24 hours before start of treatment (baseline) with Dopram® and<br>Cafeine Cooper, respectively
- Secondary Outcome Measures
Name Time Method