Dettagli per singolo studio

DEC-NET Serial number FR347

Published online	31/01/2005 14.36.00
Last updated	27/11/2006 10.20.44

Other protocol ID number
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	Cardiomyopathy
Experimental drug
dinoprostone Treatment regimen (dosage and duration) Prostine intravenously :dose reduction from 0.02 µg/kg/mnto 0.005 µg/kg/mn)with acetaminophen(paracetamol):60 mg/kg/day (IV)x 4 times
Nalbuphine Treatment regimen (dosage and duration) 200 nalpbuphine µg/kg - 6 times /day intravenously acetaminophen (paracetamol):60 mg/kg - 4 times /day
Morphine Treatment regimen (dosage and duration) Morphine : 0.3 - 1 mg/kg/day continous IV associated with acetaminophen (paracetamol):60 mg/kg 4 times/day intravenously 0.3 - 1 Morphine mg/kg/day continous IV
Gender	Both
Age (range)	birth to 28 days of life
Eligibility criteria
Inclusion criteria
Newborn infant : - with congenital ducto-dependent - hospitalized in neonnatal intensive care - treated by prostaglandins (0.02-0.1 µg/kg/min by IV) - with an EDIN score >7 - Signed parental consent
Exclusion criteria
Newborn infant : - with a condition making an urgent surgical indication in the 24 hours - with severe neurological disorders incompatible with the evaluation of EDIN score - with another factor potentially responsible for a painful symptomatology (obstetrical traumatism) - Parental refusal
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety
Design	Randomised
Purpose of study
- Principal : To study the efficacy of different analgesics in reducing the EDIN score by 50% - Secondary : To compare their efficacy and incidence of side effects




Summary of study design, objectives, and ongoing research findings
In order to determine an optimal analgesic strategy, newborn infants are included in one of the 3 groups during 72 hours: 1/ acetaminophen and nalbuphine, 2/acetaminophen and prostaglandin 3/acetaminophen and morphine. The EDIN score and tolerance are evaluated : respiratory side effects, frequency of hyperthermia , method of feeding.