Administration of Arginine Supplementation in Preterm Infants

NCT01336998 | Unknown DMC

• 1 other identifier: ALEXANDRA 9159
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Necrotizing Enterocolitis

Keywords

necrotizing enterocolitis; arginine supplementation; calprotectin

Outcome Measures

Primary Outcomes (1)

• fecal calprotectin levels

  first 28 days of life

Secondary Outcomes (1)

• necrotizing enterocolitis

  first 3 months of life

Interventions

arginine DIETARY_SUPPLEMENT

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

Also known as: L-arginine Nutricia

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• preterm neonates born at Alexandra hospital during the study period
• \< 34 weeks gestational age
• \< 1500gr birth weight

You may not qualify if:

• major congenital abnormalities
• inborn errors of metabolism
• parents not consent

Sponsors & Collaborators

• Alexandra Hospital, Athens, Greece: lead
• University of Athens: collaborator

Study Sites (1)

Alexandra Hospital

Athens, Athens, 11528, Greece

Location

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Interventions

Arginine

Condition Hierarchy (Ancestors)

Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Essential

Study Officials

• Kostalos Chistos, MD Phd

  Alexandra Hospital neonatal intensive care unit

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 15, 2011
• First Posted: April 18, 2011
• Study Start: June 1, 2009
• Primary Completion: June 1, 2011
• Last Updated: April 18, 2011

Record last verified: 2011-04

Locations

GR (1)