Premature infants with a corrected gestational age of 25
Conditions
Interventions
Trade Name: Dopram®
Pharmaceutical Form: Injection*
INN or Proposed INN: Doxapramhydrochlorid 1 H2O
CAS Number: 7081-53-0
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
C
Sponsors
RIEMSER Arzneimittel AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the efficacy and safety of Dopram® (test drug) in comparison to Cafeine Cooper (reference drug, authorised in France) in the treatment of apnoea in premature infants with the aim to investigate the equivalence (non-inferiority) of Dopram®;Secondary Objective: ;Primary end point(s): primary variable under consideration is the rate of patients with “success” under therapy, where “success” is defined as at least a 50% reduction in apnoea episodes, during the second 24 hours after start of treatment compared to the number of apnoea episodes during the last 24 hours before start of treatment (baseline) with Dopram® and Cafeine Cooper, respectively | — |
Countries
Germany
Outcome results
None listed