Enteral Granulocyte Colony Stimulating Factor and Erythropoietin Early in Life Increases Feeding Tolerance in Preterm Infants: A Randomized Controlled Trial
Primary Purpose
Feeding Intolerance, Necrotizing Enterocolitis
Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
recombinant human G-CSF, and rhEPO
rh G-CSF
rh EPO
rh G-GSF and rh EPO together
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Feeding Intolerance focused on measuring feeding intolerance, recombinant growth factors, G-CSF, EPO, necrotizing enterocolitis
Eligibility Criteria
Inclusion Criteria:
- premature neonates < 33 weeks gestational age
Exclusion Criteria:
- major congenital anomalies
- prior use of cytokines
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
G-CSF
EPO
G-CSF and EPO
Placebo
Arm Description
Outcomes
Primary Outcome Measures
The times taken to establish quarter, half, three quarters, and full enteral feeding after the drug treatment (at least 150ml/kg/day).
Time to stop parentral nutrition
Day of onset of weight gain
Duration of hospitalization
Secondary Outcome Measures
Necrotizing enterocolitis (NEC)stage (if any)
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).
Full Information
NCT ID
NCT01441427
First Posted
September 18, 2011
Last Updated
September 26, 2011
Sponsor
Ain Shams University
1. Study Identification
Unique Protocol Identification Number
NCT01441427
Brief Title
Enteral Granulocyte Colony Stimulating Factor and Erythropoietin Early in Life Increases Feeding Tolerance in Preterm Infants: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feeding Intolerance, Necrotizing Enterocolitis
Keywords
feeding intolerance, recombinant growth factors, G-CSF, EPO, necrotizing enterocolitis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
93 (Actual)
8. Arms, Groups, and Interventions
Arm Title
G-CSF
Arm Type
Experimental
Arm Title
EPO
Arm Type
Experimental
Arm Title
G-CSF and EPO
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
recombinant human G-CSF, and rhEPO
Intervention Description
G-CSF 4.5 microgram /kg/day enteral EPO 88 mIU/kg/day enteral
Intervention Type
Drug
Intervention Name(s)
rh G-CSF
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
rh EPO
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
rh G-GSF and rh EPO together
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
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
Title
Time to stop parentral nutrition
Time Frame
one month
Title
Day of onset of weight gain
Time Frame
one month
Title
Duration of hospitalization
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Necrotizing enterocolitis (NEC)stage (if any)
Description
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).
Time Frame
2 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Month
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
premature neonates < 33 weeks gestational age
Exclusion Criteria:
major congenital anomalies
prior use of cytokines
12. IPD Sharing Statement
Citations:
PubMed Identifier
25155966
Citation
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.
Results Reference
derived
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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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