Objectives :To assess the effect of probiotics on intestinal feeding tolerance in preterm infants hospitalized in 17 Shahrivar hospital of Rasht, Design: A double blind controlled clinical trial,
Participants including major eligibility criteria: 68 preterm infants with gestational age less than 36 weeks and 1000 - 2500 gram birth weight. Neonates with congenital malformations will be excluded from the study, Intervention: Eligible neonates will be assessed in two groups of treatment (oral probiotics) and control (normal saline), main outcome measures (variables): Mean duration of reaching full enteral feeding will be compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201706129075N2
Registration date:2017-09-11, 1396/06/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-11, 1396/06/20
Registrant information
Name
Seyyedeh Zohreh Jalali
Name of organization / entity
Guilan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 13 1324 5126
Email address
z_jalali@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
The Vice Chancellor of Research of Guilan University of Medical Sciences
Expected recruitment start date
2017-08-01, 1396/05/10
Expected recruitment end date
2018-04-01, 1397/01/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of probiotics on intestinal feeding tolerance in preterm infants hospitalized in 17 shahrivar hospital of Rasht
Public title
Assessing the effect of probiotics on intestinal feeding tolerance in preterm infants hospitalized in 17 shahrivar hospital of Rasht
Purpose
Supportive
Inclusion/Exclusion criteria
Main inclusion criteria: Preterm infants with gestational age less than 36 weeks; Birth weight between 1000 and 2500 gram; Age less than or equal to two weeks with enteral feeding. Main exclusion criteria: Neonates with congenital malformations (congenital heart diseases; gastrointestinal obstruction; omphalocele; gastroschisis); congenital metabolism errors; Grade two and three of asphyxia; newborns of addicted mothers; age more than two weeks.
Age
From 1 day old to 28 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
68
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Guilan University of Medical Sciences
Street address
Gaz Square
City
Rasht
Postal code
Approval date
2017-04-29, 1396/02/09
Ethics committee reference number
IR.GUMS.REC.1396.40
Health conditions studied
1
Description of health condition studied
preterm birth
ICD-10 code
P07.3
ICD-10 code description
Other preterm infants
Primary outcomes
1
Description
Mean duration of reaching full enteral feeding
Timepoint
at the discharge
Method of measurement
day
Secondary outcomes
empty
Intervention groups
1
Description
In the intervention group, administering oral probiotics with a dose of 1 drop/ kg diluted with up to 0.5 cc saline solution
Category
Rehabilitation
2
Description
In the control group, 0.5 cc of the normal saline solution will be administered every 12 hours and will be continued to reach 120 cc / kg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
17 Shahrivar Hospital
Full name of responsible person
Dr Seyyedeh Zohre Jalali
Street address
Siadati Street
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The Vice Chancellor of Resrach of Guilan niversity of Medical Sciences
Full name of responsible person
Dr Shadman Nemati
Street address
Gaz Square
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The Vice Chancellor of Resrach of Guilan niversity 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
Dr Seyyedeh Zohre Jalali
Position
Assistant Professor
Other areas of specialty/work
Street address
Siadati Street
City
Rasht
Postal code
Phone
+98 133369002
Fax
Email
z_jalali@gums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
Dr Seyyedeh Zohreh Jalali
Position
Assistant Professor
Other areas of specialty/work
Street address
Shahid Siadati Street
City
Rasht
Postal code
Phone
+98 13 3336 9002
Fax
Email
z_jalali@gums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University Of Medical Sciences
Full name of responsible person
Dr Seyyedeh Zohre Jalali
Position
Assistant Professor
Other areas of specialty/work
Street address
Siadati Street
City
Rasht
Postal code
Phone
+98 13 3336 9002
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)