Overview

This trial is active, not recruiting.

Condition necrotizing enterocolitis
Treatment arginine
Sponsor Alexandra Hospital, Athens, Greece
Collaborator University of Athens
Start date June 2009
End date June 2011
Trial size 80 participants
Trial identifier NCT01336998, ALEXANDRA 9159

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention

Primary Outcomes

Measure
fecal calprotectin levels
time frame: first 28 days of life

Secondary Outcomes

Measure
necrotizing enterocolitis
time frame: first 3 months of life

Eligibility Criteria

Male or female participants up to 3 days old.

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

Additional Information

Official title Administration of Arginine Supplementation in Preterm Infants and Measurement of Fecal Calprotectin as an Inflammatory Marker of the Intestine
Trial information was received from ClinicalTrials.gov and was last updated in April 2011.
Information provided to ClinicalTrials.gov by Alexandra Hospital, Athens, Greece.