Evaluation of feeding tolerance in very low birth weight infants given enteral Granulocyte-Colony Stimulating Factor(G-CSF) compared to historical controlled group.
We want to evaluate effect of enteral Granulocyte-Colony Stimulating Factor(G-CSF) on feeding tolerance in very low birth weight infants .
This non- randomized clinical trial study performs on preterm infants (≤1500gr birth weight) without any major anomaly. Two groups of neonates include in the study by sequential admissions.
In historical control group (n=220) the enteral feeding begin and advance with our unit’s feeding policy. In trial group (n=73) the neonates so feed with unit’s feeding policy and receive enteral G-CSF daily concurrent with feeding started and continue for 7 days.
The following outcome data will record: duration of hospital stay; mortality; time to establish one-half, two-thirds, and full enteral feedings; duration of total parenteral nutrition ; time of weight gain started; the in rate of necrotizing enterocolitis ; and adverse effects of enteral feeding and treatment (vomiting, increased gastric residual, abdominal distention, diarrhea, bloody stool, skin rash)
General information
Acronym
(G-CSF): Granulocyte-Colony Stimulating Factor
IRCT registration information
IRCT registration number:IRCT2016051427886N1
Registration date:2016-07-22, 1395/05/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-07-22, 1395/05/01
Registrant information
Name
Mahmoud Soltani
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 7020
Email address
doctorsoltani@yahoo.com
Recruitment status
Recruitment complete
Funding source
Neonatal Research Center , Shahid Beheshti University of Medical Sciences.
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
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.
Public title
Effect of enteral Granulocyte-Colony Stimulating Factor(G-CSF) in very low birth weight infants.
Purpose
Treatment
Inclusion/Exclusion 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
Reactions and intoxications due to drugs administered to fetus and newborn
Primary outcomes
1
Description
feeding tolerance
Timepoint
since start of feeding until full feeding
Method of measurement
ml/kg/day
Secondary outcomes
1
Description
hospital stay duration
Timepoint
since birth day to discharge date
Method of measurement
hospitalized date
2
Description
duration of parenteral nutrition
Timepoint
since birth day to discotinue parenteral nutrition
Method of measurement
parenteral nutrition dates
3
Description
antibiotic use
Timepoint
daily
Method of measurement
antibiotic use dates
4
Description
rate of necrotizing enterocolitis
Timepoint
daily
Method of measurement
times of occurance
5
Description
death
Timepoint
daily
Method of measurement
numbers of occurance
Intervention groups
1
Description
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.
Category
Treatment - Drugs
2
Description
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.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Mahdieh Hospital
Full name of responsible person
Dr. Seyed Abolfazl Afjeh
Street address
Fadaian Islam St
City
Tehran
2
Recruitment center
Name of recruitment center
Mofid Children Hospital
Full name of responsible person
Dr, Seyed Hossein Fakhraee
Street address
Shariati St.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neonatal Research Center
Full name of responsible person
Dr. Mohammad Kazemian
Street address
Mofid Children Hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neonatal Research Center
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Dr. Seyed Abolfazl Afjeh
Position
Attend
Other areas of specialty/work
Street address
Mahdieh Hospital
City
Tehran
Postal code
Phone
+98 55062628
Fax
Email
a.afjehi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Dr Seyed Hossein Fakhraee
Position
Attend
Other areas of specialty/work
Street address
Mofid Children Hospital , Shariati St.
City
Tehran
Postal code
Phone
+98 21 2225 1736
Fax
Email
fakhraee5@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Dr. Mahmoud Soltani
Position
Neonatal sub-specialty fello
Other areas of specialty/work
Street address
Mahdieh and Mofid Hospitals
City
Tehran
Postal code
Phone
+98 35 3720 5468
Fax
Email
doctorsoltani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)