Administration of Arginine Supplementation in Preterm Infants
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Administration of Arginine Supplementation in Preterm Infants and Measurement of Fecal Calprotectin as an Inflammatory Marker of the Intestine|
- fecal calprotectin levels [ Time Frame: first 28 days of life ] [ Designated as safety issue: No ]
- necrotizing enterocolitis [ Time Frame: first 3 months of life ] [ Designated as safety issue: No ]the incidence of necrotizing enterocolitis in the study group
|Study Start Date:||June 2009|
|Estimated Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
Dietary Supplement: arginine
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336998
|Athens, Greece, 11528|
|Study Chair:||Kostalos Chistos, MD Phd||Alexandra Hospital neonatal intensive care unit|