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

September 18, 2011
September 26, 2011
January 2010
April 2011   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01441427 on ClinicalTrials.gov Archive Site
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).
Same as current
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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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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.

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Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
  • Feeding Intolerance
  • Necrotizing Enterocolitis
  • 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.
  • 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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
93
August 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • premature neonates < 33 weeks gestational age

Exclusion Criteria:

  • major congenital anomalies
  • prior use of cytokines
Both
up to 1 Month
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01441427
FMASU 548/2010
Not Provided
Rania Ali El-Farrash, Ain Shams University
Ain Shams University
Not Provided
Not Provided
Ain Shams University
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP