Feeding in premature infants is faced with many challenges. Conventional feeding in premature infants is 20 cc/kg/day that begins within 7 to 10 days until to reach full enteral feeding (150 cc / kg / day). In this study, daily milk volumes will be increased up to 30 cc/kg/day (in interventional arm) and neonatal outcomes will be assessed in scheduled intervals in both interventional and non-interventional arms.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013041512803N2
Registration date:2015-10-03, 1394/07/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-03, 1394/07/11
Registrant information
Name
Sadroddin Mahdipour
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 1324 6963
Email address
smb1355@gmail.com
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-07-27, 1393/05/05
Expected recruitment end date
2015-05-22, 1394/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of outcome with different volumes feeding in preterm neonates in alzahra hospital in rasht city in 2014
Public title
Comparison of outcome with different volumes feeding in preterm neonates in alzahra hospital in rasht city in 2014
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: neonates without chromosomal anomaly, congenital heart disease and IUGR.
Exclusion criteria: necrotizing entric colitis (NEC); parental unwillingness to continue study.
Age
From 1 day old to 31 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Sciences
Street address
Guilan University of Medical Sciences, Gas Square
City
Rasht
Postal code
Approval date
2014-11-17, 1393/08/26
Ethics committee reference number
1930382801
Health conditions studied
1
Description of health condition studied
Preterm infant
ICD-10 code
P07.3
ICD-10 code description
28 completed weeks or more but less than 37 completed weeks (196 completed days but less than 259 completed days) of gestation.
Primary outcomes
1
Description
Mean weight
Timepoint
First week
Method of measurement
Weiting of infant by scale
Secondary outcomes
1
Description
Admittion time
Timepoint
Hospital discharge time
Method of measurement
Medical records
Intervention groups
1
Description
breast feeding or formula with 30 cc/kg/day in interventional group
Category
Other
2
Description
breast feeding or formula with 20cc/kg/day in control group
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Sadreddin Mahdipour
Street address
Alzahra Hospital
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr. Abtin Heidarzade
Street address
Guilan University of Medical Sciences, Gas Square
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan University of Medical Sciences
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
Guilan University of Medical Sciences
Full name of responsible person
Sadroddin Mahdipour
Position
Pediatrician
Other areas of specialty/work
Street address
Pediatric Disease Research Center, Alzahra hospital, Guilan University of Medical Sciences
City
Rasht
Postal code
Phone
+98 13 3336 9002
Fax
Email
s.mahdipour@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Sadroddin Mahdipour
Position
Neonatologist
Other areas of specialty/work
Street address
Pediatric Disease Research Center, Alzahra hospital, Guilan University of Medical Sciences
City
Rasht
Postal code
Phone
+98 13 3336 9002
Fax
Email
smb1355@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Sadreddin Mahdipour
Position
Pediatrician
Other areas of specialty/work
Street address
Pediatric Disease Research Center, Alzahra hospital, Guilan University of Medical Sciences
City
Rasht
Postal code
Phone
+98 13 3336 9002
Fax
Email
s.mahdipour@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)