In this controlled randomized clinical trail, 140 preterm infants are enrolled in Tabriz Alzahra Hospital in a 6 month period of time. They will be randomly assigned in three groups; feeding of milk advanced at 20 ml/kg/day (group one, 60 neonates), feeding of milk advanced at 24 ml/kg/day (group two, 40 neonates), and feeding of milk advanced at 30 ml/kg/day (group three, 40 neonates). Main study outcome is “Process of determining weight gain in premature infants” and “hospitalization days” is the study secondary outcome. Outcomes will be compared between the three groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904284417N1
Registration date:2011-06-12, 1390/03/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-06-12, 1390/03/22
Registrant information
Name
Fazileh Bashar Hashemi
Name of organization / entity
Tabriz medical university
Country
Iran (Islamic Republic of)
Phone
+98 41 1334 0062
Email address
fhashemi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2010-10-07, 1389/07/15
Expected recruitment end date
2011-04-04, 1390/01/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing outcomes of different feeding volume in preterm infants
Public title
Comparing outcomes of different feeding volume in preterm infants
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: gestational age (30-34wk), birth weight ( 1000-2000 gr) ,
Exclusion criteria: congenital anomalous, gastrointestinal obstruction, septicemia, intraventricular hemorrhage grade 3 and more, congenital heart disease.
Age
To 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
140
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
Tabriz University of Medical Sciences Ethics Committee
Street address
Golgasht Avenue, Kamarbandi Street
City
Tabriz
Postal code
Approval date
2009-10-03, 1388/07/11
Ethics committee reference number
5/4/4894
Health conditions studied
1
Description of health condition studied
Feeding premature infants
ICD-10 code
p07
ICD-10 code description
Disorders related to short gestation and low birth weight, not elsewhere classified
Primary outcomes
1
Description
Process of determining weight gain in premature infants
Timepoint
1 to 2 weeks
Method of measurement
Scale
Secondary outcomes
1
Description
Hospitalization duration
Timepoint
1 to 2 weeks
Method of measurement
Day
Intervention groups
1
Description
Intervention group 1: Milk volume of 20 ml/kg/day in 60 preterm infants
Category
Other
2
Description
Intervention group 2: Milk volume of 24 ml/kg/day in 60 preterm infants
Category
Other
3
Description
Intervention group 3: Milk volume of 30 ml/kg/day in 60 preterm infants
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Hospital
Full name of responsible person
Fazileh Bashar Hashemi
Street address
No 132, Atebba Alley, Emam Street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Golgasht Avenue, Kamarbandi Street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Science
Full name of responsible person
Fazileh Bashar Hashemi
Position
PhD - Head of neonatalogy ward
Other areas of specialty/work
Street address
No 132, Atebba Alley, Emam Street
City
Tabriz
Postal code
5154988931
Phone
+98 41 1334 0062
Fax
Email
fazileh.hashemi@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Science
Full name of responsible person
Fazileh Bashar Hashemi
Position
PhD - Neonatalogist
Other areas of specialty/work
Street address
No 132, Atebba Alley, Emam Street
City
Tabriz
Postal code
5154988931
Phone
+98 41 1334 0062
Fax
Email
fazileh.hashemi@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz Univercity of Medical Sciences
Full name of responsible person
Fazileh Bashar Hashemi
Position
PhD - Neonatologist
Other areas of specialty/work
Street address
No 132, Atebba Alley, Emam Street
City
Tabriz
Postal code
5154988931
Phone
+98 41 1334 0062
Fax
Email
fazileh.hashemi@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)