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
  Purpose

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 Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Ain Shams University:

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 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 ]

Secondary Outcome Measures:
  • 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).


Enrollment: 93
Study Start Date: January 2010
Study Completion Date: August 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   up to 1 Month
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • premature neonates < 33 weeks gestational age

Exclusion Criteria:

  • major congenital anomalies
  • prior use of cytokines
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: September 18, 2011
Last Updated: September 26, 2011
Health Authority: Egypt: Ministry of Health, Drug Policy and Planning Center

Keywords provided by 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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014