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

• Register: IRCT
• Last refreshed on: 22 February 2018
• Main ID: IRCT2016051427886N1
• Date of registration: 2016-07-22
• Prospective Registration: Yes
• Primary sponsor: Neonatal Research Center
• Public title: Effect of enteral Granulocyte-Colony Stimulating Factor(G-CSF) in very low birth weight infants.
• Scientific title: Evaluation of feeding tolerance in very low birth weight infants given enteral Granulocyte-Colony Stimulating Factor(G-CSF) compared to historical controlled group.
• Date of first enrolment: 2016-07-22
• Target sample size: 293
• Recruitment status: Complete
• URL: http://en.irct.ir/trial/22754
• Study type: interventional
• Study design: Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
• Phase: N/A

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Dr. Seyed Abolfazl Afjeh
• Affiliation: Shahid Beheshti University of Medical Science

• Name: Dr Seyed Hossein Fakhraee
• Affiliation: Shahid Beheshti University of Medical Science

Key inclusion & exclusion 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:

Age minimum: no limit
Age maximum: 28 days
Gender: Both

Health Condition(s) or Problem(s) studied

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

Reactions and intoxications due to drugs administered to fetus and newborn

Feeding problem of newborn, unspecified

Intervention(s)

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 breast milk if available, and progress by 10-20 mL/kg/day for as long as tolerate (as judge by the attending neonatologist). This feeding policy don't alter during this study.

Treatment - Drugs

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 (Filgrastim 300 micg/.5mL) concurrent with feeding started. The daily dose for each patient dilutes in sterile distilled water and administrates through the orogastric/nasogastric tube with milk feedings for 7 days.
The unit’s feeding policy is same as historical control group including to start early trophic feeding with 10-20 mL/kg/day and progress by 10-20 mL/kg/day for as long as tolerate. Intervention 2: 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 breast milk if available, and progress by 10-20 mL/kg/day for as long as tolerate (as judge by the attending neonatologist). This feeding policy don't alter during this study.

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) concurrent with feeding started. The daily dose for each patient dilutes in sterile distilled water and administrates through the orogastric/nasogastric tube with milk feedings for 7 days.
The unit’s feeding policy is same as historical control group including to start early trophic feeding with 10-20 mL/kg/day and progress by 10-20 mL/kg/day for as long as tolerate.

Primary Outcome(s)

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

Secondary Outcome(s)

Antibiotic use. Timepoint: daily. Method of measurement: antibiotic use dates.

Duration of parenteral nutrition. Timepoint: since birth day to discotinue parenteral nutrition. Method of measurement: parenteral nutrition dates.

Rate of necrotizing enterocolitis. Timepoint: daily. Method of measurement: times of occurance.

Hospital stay duration. Timepoint: since birth day to discharge date. Method of measurement: hospitalized date.

Death. Timepoint: daily. Method of measurement: numbers of occurance.

Source(s) of Monetary Support

Neonatal Research Center

Ethics review

Status: Approved
Approval date:
Contact:

Shahid Beheshti University of Medical Science