Dettagli per singolo studio

DEC-NET Serial number FR350

Published online	14/02/2005 10.51.00
Last updated	04/12/2006 11.48.26

Other protocol ID number
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	DISORDERS RELATING TO OTHER PRETERM INFANTS UNSPEC
Experimental drug
lactobacillus GG Treatment regimen (dosage and duration) The probiotics added at the begining of the meal. This supplement contains 100.000.000 bacteria and administrate 4 times per day and is continued up to the weight of 1800 g.
Bifidobacterium longum Treatment regimen (dosage and duration) The probiotics added at the begining of the meal. This supplement contains 100.000.000 bacteria and administrate 4 times per day and is continued up to the weight of 1800 g.
Gender	Both
Age (range)	term lower or equal to 34 week's amenorrhea
Eligibility criteria
Inclusion criteria
- Preterm infants(less than 15 days of life) - Birth weight lower than 1250g and higher than 500g - No disease apart from prematurity and related complications - Either breastfeeding or artificial feeding (milk for prematures) - Informed and written parental consent
Exclusion criteria
- Preterm infants aged more than 15 days - Concomitant disease contra-indicating enteral nutrition - Gestational age over 34 weeks of amenorrhea - Birthweight higher than 1250g and lower than 500g - Absence of parental consent
Trial design/methodology
Phase	4
Kind of study	Efficacy
Design	Controlled Randomised Blinded Double blind
Purpose of study
To determine the influence of early supplementation by probiotics (Bifidobacterium longum and Lactobacillus GG) on the development of the digestive flora of preterm infants.
Primary outcomes
Patients with 50% of food supply by the oral route at the postnatal age of 14 days.
Secondary outcomes
- Posttnatal age (in days) when the babies will receive more than 50% of caloric intake by the enteral route - Weight, volume of ingested milk - Intestinal flora and changes with time - Calprotectin and urinary citrulline content
Summary of study design, objectives, and ongoing research findings
The administration of probiotics (versus a placebo) aims to reduce the incidence of gastrointestinal complications and to improve the nutritional status of premature babies less than 34 weeks gestation.