Colonization of infants’ sterile intestine starts immediately after birth with harmful and beneficial bacteria. This first colonization changes rapidly under effect of infant diet. Flora microbe in term and preterm infant differs from each other. Beneficial bacteria in preterm infants is less than in term but rather the amount of potentially pathogenic bac.in preterm infant is more than term. Furthermore prescription of antibiotics and admission in NICU increased risk of neonatal infections. Though most serious infections in preterm infants due to CONS from external sources but in many cases serious infections can be developed in results of internal source particularly harmful bacteria of GI.it has been shown that adding lactulose increase flora bifidogenic and reduce pathogenic flora and increase short chain fatty acids. Short chain fatty acids improve intestinal integrity and reduce growth of pathogens and regulate intestinal movements. Based on the above we went on to investigate the effect of adding lactulose on NEC in preterm infant <1500 gr.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020110026N6
Registration date:2015-03-06, 1393/12/15
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-06, 1393/12/15
Registrant information
Name
Amir mohammad Armanian
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1235 5059
Email address
armanian@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, Isfahan, Iran
Expected recruitment start date
2014-01-01, 1392/10/11
Expected recruitment end date
2015-01-20, 1393/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
lactulose effectiveness on incidence of suspected NEC in VLBW infants in Al_zahra and shahid baheshti hospitals in Isfahan
Public title
The effect of Lactolose on premature infants
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: prematurity; birth weight equal and lower than 1500 gr; at the time of beginning milk.
Exclusion criteria: major congenital anomalies; asphyxia; GI anomalies; congenital cyanotic heart disease.
Age
To 30 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Hezar Jerib st.
City
Isfahan
Postal code
Approval date
2013-06-27, 1392/04/06
Ethics committee reference number
392273
Health conditions studied
1
Description of health condition studied
NEC
ICD-10 code
P77
ICD-10 code description
Necrotizing enterocolitis of fetus and newborn
Primary outcomes
1
Description
GI microbial changes
Timepoint
30 days
Method of measurement
Stool exam
2
Description
NEC
Timepoint
30 days
Method of measurement
Patient examination and observation
Secondary outcomes
1
Description
Hospital stay
Timepoint
30 days
Method of measurement
Daily recorded sheets
2
Description
Death
Timepoint
During hospital stay
Method of measurement
Daily recorded sheets
3
Description
Being NPO
Timepoint
30 days
Method of measurement
Daily recorded sheets
4
Description
Milk intolerance
Timepoint
30 days
Method of measurement
Daily recorded sheets
5
Description
Time of becoming full volume
Timepoint
30 days
Method of measurement
Daily recorded sheets
Intervention groups
1
Description
In the lactulose given group after consideration the inclusion and exclusion criteria for premature infant <1500gr that their milk begin lactulose 1%added and it continued on till the milk volume 150 cc/kg per day
Category
Treatment - Drugs
2
Description
In the control group after consideration the inclusion and exclusion criteria for premature infant<1500 gr that their milk begin water injectin added and it cntinues to till the milk volume to 150 cc/kg per day .
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
NICU at Alzahra and Shahid Beheshti hospitals in Isfahan IRAN
Full name of responsible person
Dr. Amir Mohammad Armanian
Street address
Number 133, Shahid Ansari alley, Saeb street, Isfahan, Iran
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Esfandiari
Street address
Faculty of Medicine, Isfahan University of Medical Sciences, Hezar Jerib st.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Elahe Shirani
Position
Resident of pediatrics
Other areas of specialty/work
Street address
Dpartment of pediatrics, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3335 3034
Fax
Email
shirani_elahe@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Amir Mohammad Armanian
Position
Neonatologist
Other areas of specialty/work
Street address
Number 133, Shahid Ansari alley, Saeb street, Isfahan, Iran
City
Isfahan
Postal code
8184757851
Phone
+98 31 3235 5059
Fax
Email
armanian@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Amir Mohammad Armanian
Position
Assistant professor of neonatology
Other areas of specialty/work
Street address
Number 133, Shahid Ansari alley, Saeb street, Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 3235 5059
Fax
Email
armanian@med.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)