Administration of Arginine Supplementation in Preterm Infants
Primary Purpose
Necrotizing Enterocolitis
Status
Unknown status
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
arginine
Sponsored by
About this trial
This is an interventional prevention trial for Necrotizing Enterocolitis focused on measuring necrotizing enterocolitis, arginine supplementation, calprotectin
Eligibility 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
Sites / Locations
- Alexandra Hospital
Outcomes
Primary Outcome Measures
fecal calprotectin levels
Secondary Outcome Measures
necrotizing enterocolitis
the incidence of necrotizing enterocolitis in the study group
Full Information
NCT ID
NCT01336998
First Posted
April 15, 2011
Last Updated
April 15, 2011
Sponsor
Alexandra Hospital, Athens, Greece
Collaborators
University of Athens
1. Study Identification
Unique Protocol Identification Number
NCT01336998
Brief Title
Administration of Arginine Supplementation in Preterm Infants
Official Title
Administration of Arginine Supplementation in Preterm Infants and Measurement of Fecal Calprotectin as an Inflammatory Marker of the Intestine
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Alexandra Hospital, Athens, Greece
Collaborators
University of Athens
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Necrotizing Enterocolitis
Keywords
necrotizing enterocolitis, arginine supplementation, calprotectin
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
arginine
Other Intervention Name(s)
L-arginine Nutricia
Intervention Description
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
Primary Outcome Measure Information:
Title
fecal calprotectin levels
Time Frame
first 28 days of life
Secondary Outcome Measure Information:
Title
necrotizing enterocolitis
Description
the incidence of necrotizing enterocolitis in the study group
Time Frame
first 3 months of life
10. Eligibility
Sex
All
Maximum Age & Unit of Time
3 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kostalos Chistos, MD Phd
Organizational Affiliation
Alexandra Hospital neonatal intensive care unit
Official's Role
Study Chair
Facility Information:
Facility Name
Alexandra Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
12. IPD Sharing Statement
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Administration of Arginine Supplementation in Preterm Infants
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