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Administration of Arginine Supplementation in Preterm Infants

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by Alexandra Hospital, Athens, Greece.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
University of Athens
Information provided by:
Alexandra Hospital, Athens, Greece
ClinicalTrials.gov Identifier:
NCT01336998
First received: April 15, 2011
Last updated: NA
Last verified: April 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Necrotizing Enterocolitis
 Dietary Supplement: arginine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Administration of Arginine Supplementation in Preterm Infants and Measurement of Fecal Calprotectin as an Inflammatory Marker of the Intestine

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alexandra Hospital, Athens, Greece:

Primary Outcome Measures:
  • fecal calprotectin levels [ Time Frame: first 28 days of life ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • necrotizing enterocolitis [ Time Frame: first 3 months of life ] [ Designated as safety issue: No ]
    the incidence of necrotizing enterocolitis in the study group


Estimated Enrollment: 80
Study Start Date: June 2009
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    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
    Other Name: L-arginine Nutricia
  Eligibility

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01336998

Locations
Greece
Alexandra Hospital
Athens, Greece, 11528
Sponsors and Collaborators
Alexandra Hospital, Athens, Greece
University of Athens
Investigators
Study Chair: Kostalos Chistos, MD Phd Alexandra Hospital neonatal intensive care unit
  More Information

No publications provided

Responsible Party: Elena Polycarpou/ MD, Pediatrician, Alexandra Hospital Athens Greece
ClinicalTrials.gov Identifier: NCT01336998     History of Changes
Other Study ID Numbers: ALEXANDRA 9159
Study First Received: April 15, 2011
Last Updated: April 15, 2011
Health Authority: Greece: Ethics Committee

Keywords provided by Alexandra Hospital, Athens, Greece:
necrotizing enterocolitis
arginine supplementation
calprotectin

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
 Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on May 22, 2013