Administration of Arginine Supplementation in Preterm Infants

Study Overview
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Brief Summary
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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.

Official Title
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Administration of Arginine Supplementation in Preterm Infants and Measurement of Fecal Calprotectin as an Inflammatory Marker of the Intestine

Conditions
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Necrotizing Enterocolitis

Intervention / Treatment
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* Dietary Supplement: arginine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 3 Days

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: arginine|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fecal calprotectin levels |  | first 28 days of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| necrotizing enterocolitis | the incidence of necrotizing enterocolitis in the study group | first 3 months of life | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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necrotizing enterocolitis, arginine supplementation, calprotectin