Enteral Granulocyte Colony Stimulating Factor and Erythropoietin Early in Life Increases Feeding Tolerance in Preterm Infants: A Randomized Controlled Trial

Phase 1

Completed

• Conditions: Feeding Intolerance; Necrotizing Enterocolitis
• Interventions: Drug: Placebo; Drug: rh G-CSF; Drug: rh EPO; Drug: recombinant human G-CSF, and rhEPO; Drug: rh G-GSF and rh EPO together

• Registration Number: NCT01441427
• Lead Sponsor: Ain Shams University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2011-04
• Study Completion: 2011-08
• Status Verified: 2011-09
• Study First Submitted: 2011-09-18
• Study First Submitted QC: 2011-09-26
• Last Update Submitted: 2011-09-26
• Study First Posted: 2011-09-27
• Last Update Posted: 2011-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

• premature neonates < 33 weeks gestational age

Exclusion Criteria

• major congenital anomalies
• prior use of cytokines

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
G-CSF	rh G-CSF	-
EPO	rh EPO	-
G-CSF and EPO	recombinant human G-CSF, and rhEPO	-
G-CSF and EPO	rh G-GSF and rh EPO together	-

Primary Outcome Measures

Name	Time	Method
Duration of hospitalization	2 months
Time to stop parentral nutrition	one month
Day of onset of weight gain	one month
The times taken to establish quarter, half, three quarters, and full enteral feeding after the drug treatment (at least 150ml/kg/day).	one month

Secondary Outcome Measures

Name	Time	Method
Necrotizing enterocolitis (NEC)stage (if any)	2 months	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).