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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
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - 1 Month (Child)All SexesDoes not accept healthy volunteers

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

    First Posted
    September 18, 2011
    Last Updated
    September 26, 2011
    Sponsor
    Ain Shams University
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    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

    Learn more about this trial

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

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