Necrotizing Enterocolitis Clinical Trial
With preterm birth, the ingestion of amniotic fluid containing enterocyte trophic factors ceases abruptly. This likely predisposes them to villous atrophy feeding intolerance and necrotizing enterocolitis(NEC) once feedings are instituted.Granulocyte Colony-Stimulating Factor (G-CSF) and Erythropoietin (EPO) have important non-hematopoietic roles in human developmental biology. Among these roles, they have trophic actions on villous height and bowel length of the developing intestine.The aim of this study is to evaluate the efficacy of enteral recombinant human G-CSF and recombinant human EPO in prevention of feeding intolerance and /or NEC in preterm infants.
Status | Completed |
Enrollment | 93 |
Est. completion date | August 2011 |
Est. primary completion date | April 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 1 Month |
Eligibility |
Inclusion Criteria: - premature neonates < 33 weeks gestational age Exclusion Criteria: - major congenital anomalies - prior use of cytokines |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The times taken to establish quarter, half, three quarters, and full enteral feeding after the drug treatment (at least 150ml/kg/day). | one month | No | |
Primary | Time to stop parentral nutrition | one month | No | |
Primary | Day of onset of weight gain | one month | No | |
Primary | Duration of hospitalization | 2 months | No | |
Secondary | Necrotizing enterocolitis (NEC)stage (if any) | Bell and colleagues proposed a clinical staging system for NEC: infants with suspected NEC (stage I), definite NEC (stage II), or advanced NEC (stage III) (Bell et al., 1978). | 2 months | Yes |
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