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

Ain Shams University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Necrotizing Enterocolitis; Feeding Intolerance

Treatments: Drug: Placebo; Drug: rh G-GSF and rh EPO together; Drug: rh EPO; Drug: rh G-CSF; Drug: recombinant human G-CSF, and rhEPO

Study type: Interventional

Funder types: Other

Identifiers

NCT01441427

FMASU 548/2010

Details and patient eligibility

About

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.

Enrollment: 93 patients

Sex: All

Ages: Under 1 month old

Volunteers: No Healthy Volunteers

Inclusion criteria

• premature neonates < 33 weeks gestational age

Exclusion criteria

• major congenital anomalies
• prior use of cytokines

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

93 participants in 4 patient groups, including a placebo group

G-CSF

Experimental group

Treatment:

Drug: rh G-CSF

EPO

Experimental group

Treatment:

Drug: rh EPO

G-CSF and EPO

Experimental group

Treatment:

Drug: rh G-GSF and rh EPO together

Drug: recombinant human G-CSF, and rhEPO

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo