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

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ClinicalTrials.gov Identifier: NCT01441427
Recruitment Status : Completed
First Posted : September 27, 2011
Last Update Posted : September 27, 2011
Sponsor:
Information provided by (Responsible Party):
Rania Ali El-Farrash, 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.

Condition or disease Intervention/treatment Phase
Feeding Intolerance Necrotizing Enterocolitis Drug: recombinant human G-CSF, and rhEPO Drug: rh G-CSF Drug: rh EPO Drug: rh G-GSF and rh EPO together Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : January 2010
Actual Primary Completion Date : April 2011
Actual Study Completion Date : August 2011

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U.S. FDA Resources

Arm Intervention/treatment
Experimental: G-CSF 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.
Experimental: EPO 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.
Experimental: G-CSF and EPO Drug: recombinant human G-CSF, and rhEPO
G-CSF 4.5 microgram /kg/day enteral EPO 88 mIU/kg/day enteral
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.
Placebo Comparator: Placebo 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.



Primary Outcome Measures :
  1. 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 ]
  2. Time to stop parentral nutrition [ Time Frame: one month ]
  3. Day of onset of weight gain [ Time Frame: one month ]
  4. Duration of hospitalization [ Time Frame: 2 months ]

Secondary Outcome Measures :
  1. Necrotizing enterocolitis (NEC)stage (if any) [ Time Frame: 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).



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Ages Eligible for Study:   up to 1 Month   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • premature neonates < 33 weeks gestational age

Exclusion Criteria:

  • major congenital anomalies
  • prior use of cytokines

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rania Ali El-Farrash, Principal investigator, Ain Shams University
ClinicalTrials.gov Identifier: NCT01441427     History of Changes
Other Study ID Numbers: FMASU 548/2010
First Posted: September 27, 2011    Key Record Dates
Last Update Posted: September 27, 2011
Last Verified: September 2011

Keywords provided by Rania Ali El-Farrash, Ain Shams University:
feeding intolerance
recombinant growth factors
G-CSF
EPO
necrotizing enterocolitis

Additional relevant MeSH terms:
Enterocolitis
Enterocolitis, Necrotizing
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Lenograstim
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs