Dettagli per singolo studio

DEC-NET Serial number FR588

Published online	12/10/2006 11.15.00
Last updated	11/07/2006 16.41.46

Other protocol ID number	N/A
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	DISORDERS RELATING TO OTHER PRETERM INFANTS 1500-1
Experimental drug
N(2)-L-alanyl-L-glutamine Treatment regimen (dosage and duration) Parenteral and enteral nutrition enriched with glutamine (0.7 g/kg per day)
Gender	Both
Age (range)	up to 10 days
Eligibility criteria
Inclusion criteria
-Premature neonates aged 30-33 weeks of gestational age -Aged at least 2 days and no more 10 days -Free of acute illness -Written informed consent is obtained from the parent prior to enrolment
Exclusion criteria
-Premature infants with respiratory (FiO2 > 30%),or cardiovascular, liver, intestinal or acute diseases -Premature infants with congenital syndrome
Trial design/methodology
Phase	4
Kind of study	Efficacy Prophylaxis
Design	Controlled Randomised Blinded Double blind
Purpose of study
Primary: Gastric emptying of enteral nutrition enriched by glutamine or isonitrogenous product. Secondary: Intestinal transit of enteral nutrition enriched by glutamine or isonitrogenous product; date and duration of arrest of nutrition if necessary; age of total enteral nutrition; age at the end of hospitalization; variation of cholescystokinine and gastrine postprandial concentration at day 0 and day 14
Primary outcomes
-Emptying gastric rate
Secondary outcomes
-intestinal transit
Summary of study design, objectives, and ongoing research findings
Forty neonates, aged at least 2 days and free of acute illness participate in a prosppective study, randomised, double-blind study. This study investigate the effects of enterally supplied glutamine on gastric emptying, intestinal transit, age of total enteral nutrition and age at the end of hospitalisation. All fed with parenteral and enteral nutrition enriched with glutamine (0.7 g kg per day, group 1) or isonitrogenous control (group2). Gastric emptying is analysed by sequential measure of intragastric residue by diluted PEG 4000.Intestinal transit is analysed by Rouge Carmin test.