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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01441427
Other study ID # FMASU 548/2010
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received September 18, 2011
Last updated September 26, 2011
Start date January 2010
Est. completion date August 2011

Study information

Verified date September 2011
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority Egypt: Ministry of Health, Drug Policy and Planning Center
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 93
Est. completion date August 2011
Est. primary completion date April 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Month
Eligibility Inclusion Criteria:

- premature neonates < 33 weeks gestational age

Exclusion Criteria:

- major congenital anomalies

- prior use of cytokines

Study Design

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


Intervention

Drug:
recombinant human G-CSF, and rhEPO
G-CSF 4.5 microgram /kg/day enteral EPO 88 mIU/kg/day enteral
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.
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.
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
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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Outcome

Type Measure Description Time frame Safety issue
Primary The times taken to establish quarter, half, three quarters, and full enteral feeding after the drug treatment (at least 150ml/kg/day). one month No
Primary Time to stop parentral nutrition one month No
Primary Day of onset of weight gain one month No
Primary Duration of hospitalization 2 months No
Secondary 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). 2 months Yes
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