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

Ain Shams University93 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Feeding Intolerance Necrotizing Enterocolitis

Interventions

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

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.

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.

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.

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.

Eligibility

Sex: ALLMax age: 1 Month

Medical Language ↔ Plain English

Inclusion Criteria: * premature neonates \< 33 weeks gestational age Exclusion Criteria: * major congenital anomalies * prior use of cytokines

Outcomes

Primary Outcomes

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

Time to stop parentral nutrition

Time frame: one month

Day of onset of weight gain

Time frame: one month

Duration of hospitalization

Time frame: 2 months

Secondary Outcomes

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).

Time frame: 2 months

Data from ClinicalTrials.gov

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