Effect of dietary supplementation of probiotic Lactobacillus reuteri on gastrointestinal complications of enteral feeding in premature infants with low birth weight
This is a triple blind randomized clinical trial was performed on 60 premature infants. The study population were preterm infants (34-28 weeks gestation), weighing 1800 to 1000 gr admitted in neonatal intensive care unit of the Shahid Sadoghi hospital's . 25 people numbers were calculated for each group of infants were randomly allocated to either the intervention group (taking a probiotic) or control (placebo). For the experimental group were given probiotic supplements orally every 12 hours at a rate of one drop per kilogram of body weight was diluted with 0.5 ml distilled water. For the placebo group was given 0.5 ml of distilled water every 12 hours. Treatment was continued until reaching full enteral feeding.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014030716870N1
Registration date:2014-04-17, 1393/01/28
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-04-17, 1393/01/28
Registrant information
Name
Khadije Nasiriani
Name of organization / entity
Yazd Shahid Sadoughi University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 1824 1755
Email address
nasiriani@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Medical College of Ali Ibn Abeetaleb
Expected recruitment start date
2012-08-22, 1391/06/01
Expected recruitment end date
2013-03-19, 1391/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of dietary supplementation of probiotic Lactobacillus reuteri on gastrointestinal complications of enteral feeding in premature infants with low birth weight
Public title
Effect of probiotic Lactobacillus reuteri on enteral feeding in premature infants
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: prematurity with birth weight 1000-1800 g.
Exclusion criteria: digestive obstruction; abdominal distension; gastrointestinal bleeding; gastroschisis, emphalocele; withdrawal syndrome; clinical or proven sepsis; congenital heart diseases and II and III degree of asphyxia.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ali ibn Abi Talib College of Medicine
Street address
Professor Hesabi Blv, Medical College of Ali Ibn Abee, Islamic Azad University,Yazd
City
Yazd
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
2883
Health conditions studied
1
Description of health condition studied
Premature infant
ICD-10 code
P07.3
ICD-10 code description
28 completed weeks or more but less than 37 completed weeks
Primary outcomes
1
Description
Enteral feeding hang time
Timepoint
Daily
Method of measurement
Daily milk volume of 120 ml / kg/day
Secondary outcomes
empty
Intervention groups
1
Description
probiotic group was prescribedone 1drop/kg probiotic supplemental orally with 0.5 ml distilled water every 12 hours.
Category
Treatment - Drugs
2
Description
The placebo group was received 0.5 ml of distilled water every 12 hours and cure was continued to reach full enteral
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Sadoughi Hospital
Full name of responsible person
Khadijeh Nasiriani
Street address
School of Nursing & Midwifery, Buali street, Safaieh, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ali ibn Abi Talib College of Medicine
Full name of responsible person
Dr. Shajari
Street address
Professor Hesabi Blv, Medical College of Ali Ibn Abee, Islamic Azad University, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ali ibn Abi Talib College of Medicine
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 Sadoughi University of Medical Sciences
Full name of responsible person
Khadijeh Nasiriani
Position
PhD in Nursing
Other areas of specialty/work
Street address
School of Nursing & Midwifery, Buali st, Safaieh, Yazd