Administration of Arginine Supplementation in Preterm Infants
NCT ID: NCT01336998
Last Updated: 2011-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
80 participants
INTERVENTIONAL
2009-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* \< 34 weeks gestational age
* \< 1500gr birth weight
Exclusion Criteria
* inborn errors of metabolism
* parents not consent
3 Days
ALL
No
Sponsors
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University of Athens
OTHER
Alexandra Hospital, Athens, Greece
OTHER
Responsible Party
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Alexandra Hospital Athens Greece
Principal Investigators
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Kostalos Chistos, MD Phd
Role: STUDY_CHAIR
Alexandra Hospital neonatal intensive care unit
Locations
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Alexandra Hospital
Athens, Athens, Greece
Countries
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Other Identifiers
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ALEXANDRA 9159
Identifier Type: -
Identifier Source: org_study_id
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