The effect of probiotics in preventing the increase of bilirubin in neonates weighting less than 2500 grams
Design
Clinical trial with control group, with parallel groups, one-way blind, randomized, phase 2 and 3 per 100 patients. Excel software rand function was used for randomization.
Settings and conduct
In neonates admitted to the intensive care unit with inclusion criteria in the study. The intervention group received 5 drops of pedilact daily for 3 days from the first day and the probiotic control group was not given. Bilirubin levels are measured daily through the skin every 24 hours for 7 days
Participants/Inclusion and exclusion criteria
Inclusion criteria: Do not have heart failure and respiratory failure;
Exclusion criteria: Critical neonates
Intervention groups
The intervention group will receive 5 drops of pedilact daily for 3 days from the first day and the probiotic control group will not be given.
Main outcome variables
Level of bilirubin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20081021001378N13
Registration date:2021-12-29, 1400/10/08
Registration timing:registered_while_recruiting
Last update:2021-12-29, 1400/10/08
Update count:0
Registration date
2021-12-29, 1400/10/08
Registrant information
Name
Ahmadshah Farhat
Name of organization / entity
Neonatal Research Center of Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 1121
Email address
farhata@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-06, 1399/10/17
Expected recruitment end date
2022-01-07, 1400/10/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of probiotics against bilirubin increase in neonates below 2500 gram.
Public title
Effects of probiotics in bilirubin increase
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Neonate weighting less than 2,500 grams are not in critical condition
Do not have krenictrose
Do not have ventilation
Do not have heart failure
Do not have asphyxia and no history of Rh incompatibility
Do not have icterus
Exclusion criteria:
Critical neonates
Phototherapy
Age
From 1 day old to 28 days old
Gender
Both
Phase
2-3
Groups that have been masked
Care provider
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of infants will be done using block methods. A random sequence will be generated using four blocks of sealedenvelope.com. The envelopes will be printed by the researcher after randomization and will be placed inside the envelopes and the envelope lids will be closed. Envelopes are numbered in random order. Then, we first explain the purpose of the study to the person and he / she will sign the informed consent and receive the intervention based on the envelope number and the order specified in it.
Blinding (investigator's opinion)
Single blinded
Blinding description
Considering that the babies do not have the necessary knowledge in this regard and the mothers have not been informed about this study, the study is therefore one-way blind and only the researcher who is performing the study knows.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
Ghoreshi Bul, Daneshgah St, Mashhad,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Approval date
2019-06-12, 1398/03/22
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1399.576
Health conditions studied
1
Description of health condition studied
hyperbilirubinemia
ICD-10 code
P59.0
ICD-10 code description
Neonatal jaundice associated with preterm delivery
Primary outcomes
1
Description
bilirubin
Timepoint
Daily for 7 days
Method of measurement
Through the surface of the skin
2
Description
Hospitalization period
Timepoint
Daily
Method of measurement
Number of days
Secondary outcomes
1
Description
Weight gain
Timepoint
Daily
Method of measurement
Balance
Intervention groups
1
Description
Intervention group: 5 drop pedilact zist takhmir probiotic .co. Iran daily for 3 days 5 ml/g from first day. And bilirubin level is measured every 24 hours for 7 days.
Category
Treatment - Drugs
2
Description
Control group: No pedilactzisttakhmir probiotic
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Nazli Parizadeh
Street address
Ibn Sina Ave, Imam Reza Hospital, Mashhad,Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
parizadehnazli@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Ghoreshi Bul, Daneshgah St, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
Parizadehnazli@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Nazli Parizadeh
Position
Resident of Pediatrics
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Ibn Sina Ave, Imam Reza Hospital, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98-051-385211121
Email
parizadehnazli@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nazli Parizadeh
Position
Resident pediatirics
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Ibn Sina Ave, Imam Reza Hospital, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3852 1121
Email
parizadehnazli@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Nazli Parizadeh
Position
Resident of Pediatrics
Latest degree
Specialist
Other areas of specialty/work
Pediatrics
Street address
Ibn Sina Ave, Imam Reza Hospital, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
91379133169
Phone
+98 51 3852 1121
Email
Parizadehnazli@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
All data can be shared after patients are made unidentified
When the data will become available and for how long
data can be accessible 6 months after results are published
To whom data/document is available
Data can be accessible through an email to the corresponding author
Under which criteria data/document could be used
data will be available for researchers in universities and other scientific institution
From where data/document is obtainable
After sending a request email to the corresponding author , data will be sent in 1 month.
What processes are involved for a request to access data/document