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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:
ClinicalTrials.gov Identifier:
NCT01441427
First Posted: September 27, 2011
Last Update Posted: September 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Rania Ali El-Farrash, Ain Shams University
September 18, 2011
September 27, 2011
September 27, 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 ]
  • 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 ]
Same as current
No Changes Posted
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).
Same as current
Not Provided
Not Provided
 
Enteral Granulocyte Colony Stimulating Factor and Erythropoietin Early in Life Increases Feeding Tolerance in Preterm Infants: A Randomized Controlled Trial
Not Provided
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, 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
El-Ganzoury MM, Awad HA, El-Farrash RA, El-Gammasy TM, Ismail EA, Mohamed HE, Suliman SM. Enteral granulocyte-colony stimulating factor and erythropoietin early in life improves feeding tolerance in preterm infants: a randomized controlled trial. J Pediatr. 2014 Dec;165(6):1140-1145.e1. doi: 10.1016/j.jpeds.2014.07.034. Epub 2014 Aug 23.

*   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
Sexes Eligible for Study: All
up to 1 Month   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01441427
FMASU 548/2010
Not Provided
Not Provided
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