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

Overview

No summary available.

Registry

who.int

Start Date

May 11, 2009

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- 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

•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.