Administration of Arginine Supplementation in Preterm Infants

Necrotizing Enterocolitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01336998
• Other study ID #: ALEXANDRA 9159
• Status: Active, not recruiting
• Phase: N/A
• First received: April 15, 2011
• Last updated: April 15, 2011
• Start date: June 2009

Study information

• Verified date: April 2011
• Source: Alexandra Hospital, Athens, Greece
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

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

Locations

Country	Name	City	State
Greece	Alexandra Hospital	Athens

Sponsors (2)

Lead Sponsor	Collaborator
Alexandra Hospital, Athens, Greece	University of Athens

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fecal calprotectin levels		first 28 days of life	No
Secondary	necrotizing enterocolitis	the incidence of necrotizing enterocolitis in the study group	first 3 months of life	No