---
title: "Enteral Granulocyte Colony Stimulating Factor and Erythropoietin Early in Life Increases Feeding Tolerance in Preterm Infants: A Randomized Controlled Trial"
nct_id: NCT01441427
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: Ain Shams University
study_type: INTERVENTIONAL
primary_condition: Feeding Intolerance
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01441427.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01441427"
ct_last_update_post_date: 2011-09-27
last_seen_at: "2026-05-12T07:02:53.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Enteral Granulocyte Colony Stimulating Factor and Erythropoietin Early in Life Increases Feeding Tolerance in Preterm Infants: A Randomized Controlled Trial

**NCT ID:** [NCT01441427](https://clinicaltrials.gov/study/NCT01441427)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 93
- **Lead Sponsor:** Ain Shams University
- **Conditions:** Feeding Intolerance, Necrotizing Enterocolitis
- **Start Date:** 2010-01
- **Completion Date:** 2011-08
- **CT.gov Last Update:** 2011-09-27

## 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.

## Eligibility

- **Maximum age:** 1 Month
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* premature neonates \< 33 weeks gestational age

Exclusion Criteria:

* major congenital anomalies
* prior use of cytokines
```

## Arms

- **G-CSF** (EXPERIMENTAL)
- **EPO** (EXPERIMENTAL)
- **G-CSF and EPO** (EXPERIMENTAL)
- **Placebo** (PLACEBO_COMPARATOR)

## Interventions

- **recombinant human G-CSF, and rhEPO** (DRUG) — G-CSF 4.5 microgram /kg/day enteral EPO 88 mIU/kg/day enteral
- **rh G-CSF** (DRUG) — Dosage: 4.5 µg/ kg (diluted into 1 ml distilled water) administered once daily by an orogastric tube till the enteral intake reached 100 mL/kg of milk, or after a maximum of seven days.
- **rh EPO** (DRUG) — Dosage: 88 IU/ kg once daily (diluted into 1 ml distilled water) administered by an orogastric tube till the enteral intake reached 100 mL/kg of milk, or after a maximum of seven days.
- **rh G-GSF and rh EPO together** (DRUG) — EPO dosage: 88 IU/ kg once daily i.e 88000 mU/kg/day (diluted into 1 ml distilled water) administered by an orogastric tube till the enteral intake reached 100 mL/kg of milk, or after a maximum of seven days.G-CSF dosage: 4.5 µg/ kg (diluted into 1 ml distilled water) administered once daily by an orogastric tube till the enteral intake reached 100 mL/kg of milk, or after a maximum of seven days.
- **Placebo** (DRUG) — distilled water :1 ml distilled water administered by an orogastric tube till the enteral intake reached 100 mL/kg of milk, or after a maximum of seven days.

## Primary Outcomes

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

## Secondary Outcomes

- **Necrotizing enterocolitis (NEC)stage (if any)** _(time frame: 2 months)_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01441427.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01441427*  
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