drugset / Trial / NCT01441427

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

NCT01441427

Phase 1/2 Completed 93 enrolled Ain Shams University
RandomizedParallel-groupTriple-blindPrevention

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.

Timeline

Start
2010-01
Primary completion
2011-04
Completion
2011-08

Drugs

EvaluationDrugModalityDoseRoute
Subject filgrastim Protein / enzyme biologic 4.5 ug/kg Other
Subject rhEPO Protein / enzyme biologic 88 iu/kg Other