Administration of Arginine Supplementation in Preterm Infants
Administration of Arginine Supplementation in Preterm Infants and Measurement of Fecal Calprotectin as an Inflammatory Marker of the Intestine
Lead Sponsor: Alexandra Hospital, Athens, Greece
Collaborator: University of Athens
|Source||Alexandra Hospital, Athens, Greece|
Calprotectin is a cytosolic component of neutrophils .Fecal calprotectin(FC) is a useful marker for exacerbation of inflammatory bowel disease in children .FC may be a useful marker for necrotizing enterocolitis (NEC).
NEC is one of the most common ,deadliest and enigmatic intestinal problems encountered mostly in premature infants. The precise pathophysiology of NEC is unclear ,but major factors thought to play an important role include an immature intestine ,an inflammatory response to intestinal microbes,enteral feedings and intestinal ischemia-reperfusion injury.Diagnosis of NEC is not easy clinically and up to now there is not a simple laboratory test to differentiate NEC at an early stage from other conditions in the neonate.
Arginine is the substrate for NO production in the gut and its deficiency may cause vasoconstriction and gut injury and thus predispose to NEC. In previous studies arginine supplementation was found to reduce the incidence of NEC in premature infants but more studies are needed for the use of arginine supplementation for the prevention of NEC.
The investigators aim is to measure the fecal calprotectin in very low birth weight (VLBW) infants during the first month of life as an inflammatory marker of the bowel and evaluate whether premature infants receiving arginine supplements had lower calprotectin values compared to the premature infants that did not .
The investigators hypothesize that arginine supplementation in preterm infants reduces the inflammation of the gut which will be shown by the lower fecal calprotectin values of the premature infants receiving arginine supplementation.
|Overall Status||Unknown status|
|Start Date||June 2009|
|Primary Completion Date||June 2011|
Intervention Type: Dietary Supplement
Intervention Name: arginine
Description: oral L-arginine supplementation 261mg/kg/day (1,5mmol/kg/day), one dose daily ,from the 3rd day of life until the 28th day of life
Other Name: L-arginine Nutricia
Inclusion Criteria: - preterm neonates born at Alexandra hospital during the study period - < 34 weeks gestational age - < 1500gr birth weight Exclusion Criteria: - major congenital abnormalities - inborn errors of metabolism - parents not consent
- preterm neonates born at Alexandra hospital during the study period
- < 34 weeks gestational age
- < 1500gr birth weight
- major congenital abnormalities
- inborn errors of metabolism
- parents not consent
Minimum Age: N/A
Maximum Age: 3 Days
Healthy Volunteers: No
Name Title: Elena Polycarpou/ MD, Pediatrician
Organization: Alexandra Hospital Athens Greece
|Has Expanded Access||No|
|Study Design Info||
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)