Administration of Arginine Supplementation in Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01336998
Recruitment Status : Unknown
Verified April 2011 by Alexandra Hospital, Athens, Greece.
Recruitment status was:  Active, not recruiting
First Posted : April 18, 2011
Last Update Posted : April 18, 2011
University of Athens
Information provided by:
Alexandra Hospital, Athens, Greece

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.

Condition or disease Intervention/treatment Phase
Necrotizing Enterocolitis Dietary Supplement: arginine Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : June 2009
Estimated Primary Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. fecal calprotectin levels [ Time Frame: first 28 days of life ]

Secondary Outcome Measures :
  1. necrotizing enterocolitis [ Time Frame: first 3 months of life ]
    the incidence of necrotizing enterocolitis in the study group

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01336998

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

Responsible Party: Elena Polycarpou/ MD, Pediatrician, Alexandra Hospital Athens Greece Identifier: NCT01336998     History of Changes
Other Study ID Numbers: ALEXANDRA 9159
First Posted: April 18, 2011    Key Record Dates
Last Update Posted: April 18, 2011
Last Verified: April 2011

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

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