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

Sponsors

Lead Sponsor: Alexandra Hospital, Athens, Greece

Collaborator: University of Athens

Source Alexandra Hospital, Athens, Greece
Brief Summary

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
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
fecal calprotectin levels first 28 days of life
Secondary Outcome
Measure Time Frame
necrotizing enterocolitis first 3 months of life
Enrollment 80
Condition
Intervention

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

Eligibility

Criteria:

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

Gender: All

Minimum Age: N/A

Maximum Age: 3 Days

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Kostalos Chistos, MD Phd Study Chair Alexandra Hospital neonatal intensive care unit
Location
Facility: Alexandra Hospital
Location Countries

Greece

Verification Date

April 2011

Responsible Party

Name Title: Elena Polycarpou/ MD, Pediatrician

Organization: Alexandra Hospital Athens Greece

Keywords
Has Expanded Access No
Condition Browse
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov