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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Rania Ali El-Farrash, Ain Shams University

ClinicalTrials.gov Identifier:

NCT01441427

First received: September 18, 2011

Last updated: September 26, 2011

Last verified: September 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	September 18, 2011
Last Updated Date	September 26, 2011
Start Date ^ICMJE	January 2010
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 26, 2011)	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 ] [ Designated as safety issue: No ] Time to stop parentral nutrition [ Time Frame: one month ] [ Designated as safety issue: No ] Day of onset of weight gain [ Time Frame: one month ] [ Designated as safety issue: No ] Duration of hospitalization [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01441427 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 26, 2011)	Necrotizing enterocolitis (NEC)stage (if any) [ Time Frame: 2 months ] [ Designated as safety issue: Yes ] 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).
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Enteral Granulocyte Colony Stimulating Factor and Erythropoietin Early in Life Increases Feeding Tolerance in Preterm Infants: A Randomized Controlled Trial
Official Title ^ICMJE	Not Provided
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 Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Feeding Intolerance Necrotizing Enterocolitis
Intervention ^ICMJE	Drug: recombinant human G-CSF, and rhEPO G-CSF 4.5 microgram /kg/day enteral EPO 88 mIU/kg/day enteral Drug: rh 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. Drug: rh EPO 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. Drug: rh G-GSF and rh EPO together 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. Drug: Placebo 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.
Study Arm (s)	Experimental: G-CSF Intervention: Drug: rh G-CSF Experimental: EPO Intervention: Drug: rh EPO Experimental: G-CSF and EPO Interventions: Drug: recombinant human G-CSF, and rhEPO Drug: rh G-GSF and rh EPO together Placebo Comparator: Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	93
Completion Date	August 2011
Primary Completion Date	April 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: premature neonates < 33 weeks gestational age Exclusion Criteria: major congenital anomalies prior use of cytokines
Gender	Both
Ages	up to 1 Month
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01441427
Other Study ID Numbers ^ICMJE	FMASU 548/2010
Has Data Monitoring Committee	Not Provided
Responsible Party	Rania Ali El-Farrash, Ain Shams University
Study Sponsor ^ICMJE	Ain Shams University
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Ain Shams University
Verification Date	September 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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