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
Verified date | April 2011 |
Source | Alexandra Hospital, Athens, Greece |
Contact | n/a |
Is FDA regulated | No |
Health authority | Greece: Ethics Committee |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Greece | Alexandra Hospital | Athens |
Lead Sponsor | Collaborator |
---|---|
Alexandra Hospital, Athens, Greece | University of Athens |
Greece,
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 |
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