Comparison of the effect of phototherapy with phototherapy + probiotic in neonates
with icter in Qazvin Kosar Hospital
Design
44 patients were studied. The first group received usual phototherapy + distilled water and the second group received 5 drops of Pedilact (probiotic) 2 times daily for 3 days in addition to phototherapy, and hospitalization and Bilirubin reduction rates based on gestational age and sex in both groups were compared.
Settings and conduct
Each group has 44 patients. Category
The first group receives usual phototherapy + distilled water and the second group besides phototherapy, Pedilact drops
(Probiotics) 5 drops, given 2 times a day in 3 days by the pediatric resident, The resident unconsciously gives the baby a pedilact drop or distilled water
the pediatric resident not have any
Information about which group of probiotic drop babies with phototherapy and which phototherapy group only
This is done in the neonatal ward of Qazvin Kowsar Hospital.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: Icteric neonates at Kosar Hospital who have no symptoms of Sepsis and respiratory distress are not admitted to the NICU and have no underlying disease.Exclusion criteria: Sepsis, respiratory distress and seizure, pre-term infants 35 weeks, for any reason that the infant becomes critically ill during examination and hospitalization.
Intervention groups
In one group, a probiotic (pedilact drop) study was performed to reduce neonatal jaundice given orally twice daily and five drops daily for three days with phototherapy at Kosar Hospital, the other group only had phototherapy to reduce jaundice.
Main outcome variables
The main variable is bilirubin. In this study the effect of probiotic on bilirubin is investigated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191022045194N1
Registration date:2020-03-29, 1399/01/10
Registration timing:prospective
Last update:2020-03-29, 1399/01/10
Update count:0
Registration date
2020-03-29, 1399/01/10
Registrant information
Name
Hanna Sanandaji
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3334 4157
Email address
hanisndj@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of phototherapy with probiotic + phototherapy alone in neonates with icter in Qazvin Kowsar Hospital
Public title
Comparison of the effect of phototherapy with phototherapy + probiotics only in infants with icter
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Inclusion criteria include: icteric neonates at Kosar Hospital who have no symptoms of Sepsis .
Icteric neonates admitted to Kosar Hospital with no respiratory distress
Icteric neonates hospitalized at Kosar Hospital who are not admitted to the NICU
Icteric neonates admitted to Kosar Hospital with no underlying disease
Exclusion criteria:
Exclusion criteria: For any reason, the baby will be critically ill during the examination and hospitalization
For whatever reason, the baby may develop respiratory distress
For any reason, the baby may have seizures
For whatever reason, the baby will receive medication
Age
From 2 days old to 14 days old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
In each group, 44 patients were studied. The first group received usual phototherapy + distilled water and the second group received 5 drops of Pedilact (probiotic) 2 times daily for 3 days in addition to phototherapy, and hospitalization and Bili reduction rates based on gestational age and sex in both groups were compared. Can be. Also, the method of implementation is to inform the resident of the project by unconsciously examining the reduction of Bili in the two groups and not knowing which groups of probiotic drops infants receive phototherapy and which groups receive phototherapy alone.
Blinding (investigator's opinion)
Double blinded
Blinding description
In each group, 44 patients were studied. The first group received usual phototherapy + distilled water and the second group received 5 drops of Pedilact (probiotic) 2 times daily for 3 days in addition to phototherapy, and hospitalization and Bili reduction rates based on gestational age and sex in both groups were compared. Can be. Also, the method of implementation is to inform the resident of the project by unconsciously examining the reduction of Bili in the two groups and not knowing which groups of probiotic drops infants receive phototherapy and which groups receive phototherapy alone.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Qazvin University of Medical Science
Street address
Qods hospital,Qods sq,Shahidbeheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3415914595
Approval date
2019-05-28, 1398/03/07
Ethics committee reference number
IR.QUMS.REC.1398.041
Health conditions studied
1
Description of health condition studied
neonatal ichter
ICD-10 code
P59.9
ICD-10 code description
Neonatal jaundice, unspecified
Primary outcomes
1
Description
Bilirubin
Timepoint
one week
Method of measurement
Plasma Bilirubin Level
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:Neonates who intake pedilact drop
Category
Treatment - Drugs
2
Description
Control group: Neonates who don not intake any drugs
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kosar Hospital
Full name of responsible person
Hanna Sanandaji
Street address
Qods hospital,Qods Square,Felestin st.
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
+98 28 3333 4807
Email
Hanisndj@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Mahdi Emamjome
Street address
Shahid Bahonar Blv.,Qazvin University of Medical Science
City
Qazvin
Province
Qazvin
Postal code
4595134159
Phone
+98 28 3333 4807
Email
Cgd_rc@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Morteza Habibi
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kowsar hospital,kowsar Ave,Khamenei Blvd
City
Qazvin
Province
Qazvin
Postal code
3415613176
Phone
+98 28 3323 6374
Email
drmhabibi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Morteza Habibi
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Kowsar Hospital,Kowsar Ave,Khamenei Blvd
City
Qazvin
Province
Qazvin
Postal code
3416613176
Phone
+98 28 3323 6374
Email
drmhabibi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Hanna Sanandaji
Position
resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qods hospital,Qods Sq,Shahid beheshti Blvd
City
Qazvin
Province
Qazvin
Postal code
3415914595
Phone
98 28 3334808
Email
hanisndj@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Report data as an article
When the data will become available and for how long
After completing the sampling and analysis of the data interpretation, the information will be published as an article.
To whom data/document is available
In coordination with the supervisor of researchers working in academic institutions
Under which criteria data/document could be used
For writing meta-analysis articles
From where data/document is obtainable
Dr Morteza Habibi,Neonatal specialist .Address:Kowsar Hospital, Kowsar Avn, Khamenei Blvd ,Qazvin. Tel:982833236374
Dr Hanna Sanandaji,Pediatric resident.Address:Qods Hospital, Qods Sq, Shahid beheshti Blvd, Qazvin. Tel:98283334808
What processes are involved for a request to access data/document
Send a formal letter by email or to the address of the project