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:
Ain Shams University
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
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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 May 16, 2013