Subject: Efficacy of probiotic with phototherapy in compare to phototherapy for treatment of hyperbilirubinemia in fullterm neonates admitted to shahid Madani hospital in Khorramabad
inclusion criteria: gestational age 37-40 weeks; birth weight 2500-4000 gram; apgar score 8-10 in first and fifth minute.
exclusion criteria: sepsis; G6PD deficiency; congenital anomaly; asphyxia; heart disease ;IUGR; contraindication for probiotic therapy.
Volume:35 neonates in each group.
Interventions: neonates would be divided into two groups as intervention and control. Control group are treated with phototherapy as routine therapy and the next group is treated with phototherapy and probiotic 5 drops orally every day. Serum bilirubin would be checked every day until it receives to less than 11mg/dl and neonate be discharged.
Time: 22.12.2015 to 21.05.2016.
Primary outcome: bilirubin
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015112925287N1
Registration date:2015-12-18, 1394/09/27
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-12-18, 1394/09/27
Registrant information
Name
Shokufe Ahmadipour
Name of organization / entity
Lorestan Univercity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 66 3341 1439
Email address
ahmadipour.sh@lums.ac.ir
Recruitment status
Recruitment complete
Funding source
Lorestan University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of probiotic with phototherapy in compare to phototherapy for treatment of hyperbilirubinemia in fullterm infants
Public title
Efficacy of probiotic in jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: gestational age 37-40 weeks; birth weight 2500-4000 gram; apgar score 8-10 in first and fifth minute.
exclusion criteria: sepsis; G6PD deficiency; congenital anomaly; asphyxia; heart disease ;IUGR; contraindication for probiotic therapy.
Age
From 2 days old to 7 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
Lorestan University of Medical Sciences
Street address
Kamalvand campus, Khorramabad
City
Khorramabad
Postal code
Approval date
2015-09-01, 1394/06/10
Ethics committee reference number
LUMS.REC.1394.17
Health conditions studied
1
Description of health condition studied
hyperbilirubinemia
ICD-10 code
p59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
bilirubin
Timepoint
before intervention-every day after intervention
Method of measurement
lab test-milligram per desiliter
Secondary outcomes
1
Description
weight
Timepoint
before intervention-every day after intervention
Method of measurement
balance-gram
Intervention groups
1
Description
intervention group: in addition to phototherapy neonates will be treated by 5 drops of probiotic (pedilact) once a day till discharge.
Category
Treatment - Drugs
2
Description
control group: during hospitalization only receive phototherapy
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
shahid Madani hospital
Full name of responsible person
dr Shokufe Ahmadipour
Street address
City
Khorramabad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
dr Morovat Taheri kalani
Street address
research center
City
Khorramabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Lorestan 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
Lorestan University of Medical Sciences
Full name of responsible person
Shokufe Ahmadipour
Position
Pediatricians
Other areas of specialty/work
Street address
shahid Madani hospital
City
Khorramabad
Postal code
Phone
+98 66 3341 1439
Fax
Email
ahmadipour_sh@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
dr Shokufe Ahmadipour
Position
Pediatricians
Other areas of specialty/work
Street address
shahid Madani hospital
City
Khorramabad
Postal code
Phone
+98 66 3341 1439
Fax
Email
ahmadipour.sh@yahoo.comzm.sabzevari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Lorestan University of Medical Sciences
Full name of responsible person
dr Shokufe Ahmadipour
Position
Pediatricians
Other areas of specialty/work
Street address
shahid Madani hospital
City
Khorramabad
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)