Effect of enteral Granulocyte-Colony Stimulating Factor(G-CSF) in very low birth weight infants.

Evaluation of feeding tolerance in very low birth weight infants given enteral Granulocyte-Colony Stimulating Factor(G-CSF) compared to historical controlled group.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016051427886N1

Enrollment

293

Registered

2016-07-22

Start date

2016-07-22

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: feeding tolerance in newborns. Condition 2: Reactions due to drugs administered to newborn. Feeding problem of newborn, unspecified Reactions and intoxications due to drugs administered to fetus and newborn

Interventions

Intervention 1: The 73 included newborns in trial group receive enteral G-CSF. These neonates feed with the unit’s feeding policy and receive a single daily dose of enteral G-CSF, 5 micg/kg (Filgrasti

Treatment - Drugs

The 73 included newborns in trial group receive enteral G-CSF. These neonates feed with the unit’s feeding policy and receive a single daily dose of enteral G-CSF, 5 micg/kg (Filgrastim 300 micg/.5mL)

In historical control group (n=220) the enteral feeding begin and advance with our unit’s feeding policy. Our unit’s feeding policy is to start early trophic feeding with 10-20 mL/kg/day, preferably b

Eligibility

Sex/Gender

All

Age

No minimum to 28 Days

Inclusion criteria

Inclusion criteria: Inclusion criteria: All preterm newborns with birth weight less than 1500 gram Exclusion criteria : Congenital anomalies of the gastrointestinal tract (such as omphalocele, gastroschisis, tracheoesophageal fistula); Acquired GI disorders such as GI perforation , obstruction and necrotising enterocolitis; Other major anomalies such as congenital cyanotic heart disease, neural tube defect, diaphragmatic hernia and trisomy

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Feeding tolerance. Timepoint: since start of feeding until full feeding. Method of measurement: ml/kg/day.	—

Secondary

Measure	Time frame
Hospital stay duration. Timepoint: since birth day to discharge date. Method of measurement: hospitalized date.;Duration of parenteral nutrition. Timepoint: since birth day to discotinue parenteral nutrition. Method of measurement: parenteral nutrition dates.;Antibiotic use. Timepoint: daily. Method of measurement: antibiotic use dates.;Rate of necrotizing enterocolitis. Timepoint: daily. Method of measurement: times of occurance.;Death. Timepoint: daily. Method of measurement: numbers of occurance.	—

Measure

Time frame

Hospital stay duration. Timepoint: since birth day to discharge date. Method of measurement: hospitalized date.;Duration of parenteral nutrition. Timepoint: since birth day to discotinue parenteral nutrition. Method of measurement: parenteral nutrition dates.;Antibiotic use. Timepoint: daily. Method of measurement: antibiotic use dates.;Rate of necrotizing enterocolitis. Timepoint: daily. Method of measurement: times of occurance.;Death. Timepoint: daily. Method of measurement: numbers of occurance.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Seyed Abolfazl Afjeh

Shahid Beheshti University of Medical Science

a.afjehi@gmail.com+98 55062628

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026