The aim of this study was to evaluate the effect of probiotics in preventing necrotizing enterocolitis in preterm infants under 1500 grams,
Including criteria, stable neonate that began feeding.
Population of study, hospitalize infant under 1500gr in Hafez Hospital that 83 cases and 83 control were considered. After starting probiotict drop they follow clinically exam daily.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014072618591N1
Registration date:2014-09-17, 1393/06/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-09-17, 1393/06/26
Registrant information
Name
Seyed Mostajab Razavi
Name of organization / entity
Shiraz University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 71 3612 5479
Email address
razavimo@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University Of Medical Science
Expected recruitment start date
2014-05-22, 1393/03/01
Expected recruitment end date
2014-11-22, 1393/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of probiotic in prevention of Necroziting Entrocolitis in preterm infants in Hafez hospital
Public title
Effect of probiotic in prevention of Necroziting Entrocolitis in preterm infants in Hafez hospital
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: premature neonate with 1500 gr and below that stable and tolerate (10cc/kg/day) formula or breast milk.
exclusion criteria: decline to participate; sever congenital anomaly; death
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
166
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
Shiraz University Of Medical Science
Street address
Building of Shiraz University Of Medical Science, Zand street, Shiraz
City
Shiraz
Postal code
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
CT-P-9367-6757
Health conditions studied
1
Description of health condition studied
Necrotizing enterocolitis
ICD-10 code
A09.0
ICD-10 code description
Other and unspecified gastroenteritis and colitis of infectious origin
Primary outcomes
1
Description
sign and symptom of NEC
Timepoint
daily examination
Method of measurement
clinical evaluation
Secondary outcomes
1
Description
feeding tolerant
Timepoint
daily examination
Method of measurement
clinical follow up
Intervention groups
1
Description
Intervention group: add probiotics (Probiotic drops Pedilact Manufacturing zist takhmir) milk at the rate of 0/1cc/kg/day until hospital
Category
Treatment - Drugs
2
Description
control group: The control group was used as control and did not receive drug
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hafez Hosoital
Full name of responsible person
Dr. Fazel Makvandi
Street address
Hafez Hospital, chamran street, Shiraz
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Dean Of Research Of Shiraz University Of Medical Science
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
7th Floor dean of research, Building of University Of Medical Science, Zand street, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Dean Of Research Of Shiraz University Of Medical Science
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
Neonatology research center, Shiraz University Of Medical Science
Full name of responsible person
Dr.Shahnaz Pourarian
Position
Professor of Neonatology
Other areas of specialty/work
Street address
Neonatology research center,Neonatal department, Namazi Hospital, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3612 5479
Fax
Email
porarish@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Neonatology Research Center, Shiraz University Of Medical Science
Full name of responsible person
Dr.Seyed Mostajab Razavi
Position
Associated Professor of Neonatalogy
Other areas of specialty/work
Street address
Neonatal Research Center, Neonatal Department, Namazi Hospital, Zand Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3612 5479
Fax
Email
razavimo@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University Of Medical Science
Full name of responsible person
Dr.Fazel Makvandi
Position
Flowship of neonatal
Other areas of specialty/work
Street address
Neonatal Research Center, Neonatal Department, Nemazee Hospital, Zand Street, Shiraz
City
Shiraz
Postal code
Phone
+98 71 3612 5479
Fax
Email
fazelmakvandi21@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)