NCT01441427

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 18, 2011

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 27, 2011

Completed
Last Updated

September 27, 2011

Status Verified

September 1, 2011

Enrollment Period

1.2 years

First QC Date

September 18, 2011

Last Update Submit

September 26, 2011

Conditions

Feeding IntoleranceNecrotizing Enterocolitis

Keywords

feeding intolerancerecombinant growth factorsG-CSFEPOnecrotizing enterocolitis

Outcome Measures

Primary Outcomes (4)

  • The times taken to establish quarter, half, three quarters, and full enteral feeding after the drug treatment (at least 150ml/kg/day).

    one month

  • Time to stop parentral nutrition

    one month

  • Day of onset of weight gain

    one month

  • Duration of hospitalization

    2 months

Secondary Outcomes (1)

  • Necrotizing enterocolitis (NEC)stage (if any)

    2 months

Study Arms (4)

G-CSF

EXPERIMENTAL
Drug: rh G-CSF

EPO

EXPERIMENTAL
Drug: rh EPO

G-CSF and EPO

EXPERIMENTAL
Drug: recombinant human G-CSF, and rhEPODrug: rh G-GSF and rh EPO together

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

recombinant human G-CSF, and rhEPODRUG

G-CSF 4.5 microgram /kg/day enteral EPO 88 mIU/kg/day enteral

G-CSF and EPO
rh G-CSFDRUG

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.

G-CSF
rh EPODRUG

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.

EPO
rh G-GSF and rh EPO togetherDRUG

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.

G-CSF and EPO
PlaceboDRUG

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.

Placebo

Eligibility Criteria

AgeUp to 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • premature neonates \< 33 weeks gestational age

You may not qualify if:

  • major congenital anomalies
  • prior use of cytokines

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 25155966DERIVED

MeSH Terms

Conditions

Enterocolitis, Necrotizing

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 18, 2011

First Posted

September 27, 2011

Study Start

January 1, 2010

Primary Completion

April 1, 2011

Study Completion

August 1, 2011

Last Updated

September 27, 2011

Record last verified: 2011-09