Investigating the effectiveness of probiotics in the treatment of jaundice in newborns
Design
Randomized clinical trial without blinded strain on 100 newborns with jaundice under treatment, who are divided into two intervention and control groups, and they differ only in terms of receiving probiotic drops, and to control confounding variables, logistic regression modeling methods were used.
is used
Settings and conduct
Jaundiced newborns admitted to Mufaid Children's Hospital
Participants/Inclusion and exclusion criteria
Exclusion criteria include; Birth weight less than two kilos, birth age less than 35 weeks, physiological jaundice and bilirubin less than 15.Bilirubin is above 25 and requires blood exchange and the presence of co-morbidities in the newborn, as well as the parents' lack of consent
Intervention groups
Accelerating the effect of probiotic drops in the treatment of neonatal jaundice
Main outcome variables
The result of the study is the acceleration of the recovery of neonatal jaundice and no harm has been observed in the treatment with probiotic drops
General information
Reason for update
Acronym
EPN
IRCT registration information
IRCT registration number:IRCT20231020059774N1
Registration date:2023-12-05, 1402/09/14
Registration timing:registered_while_recruiting
Last update:2023-12-05, 1402/09/14
Update count:0
Registration date
2023-12-05, 1402/09/14
Registrant information
Name
Samereh Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 912 495 6577
Email address
samikh1985@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-22, 1402/09/01
Expected recruitment end date
2025-03-20, 1403/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effectiveness of probiotics in the treatment of jaundice in term and near_term newborns
Public title
Investigating the effectiveness of probiotics in the newborns
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A newborn with a birth weight of more than 2 kg
Childbirth age greater than 37 weeks
Non-physiological jaundice and bilirubin more than 15
A newborn with bilirubin less than 25
A newborn doesnot need blood transfusion
A newborn without abnormalities and comorbidities
Parental consent
Exclusion criteria:
A newborn less than 2 days old
Childbirth age less than 35 weeks
Pathological jaundice
A newborn with bilirubin above 20
A newborn with malformations and other co-morbidities
A newborn needs a blood transfusion
Age
From 2 days old to 28 days old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Due to the fact that with the simple randomization method, there was a possibility that the balance between the groups would not be established, the method of examining the random allocation plan will be block randomization (Permuted).
(block randomization
in such a way that 100 people (determined according to the sample size)
Divide into 25 blocks by using blocks of 4 and then as
concealment
will be assigned to study groups. In this study, the main researchers and the patient's parents did not know about the randomization method and random block allocation by
The epidemiologist will do the planning
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid beheshti University of Medical Sciences
Neonatal jaundice from other and unspecified causes
Primary outcomes
1
Description
Rapid decrease in bilirubinا
Timepoint
The beginning of hospitalization and the course of treatment and the time of discharge
Method of measurement
Bilirubin level in blood test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 50 newborns with jaundice will be randomly given 5 drops of (Reuteflor ) probiotic daily and its effect on reducing the duration of hospitalization of infants compared to the control group will be investigated.
Category
Treatment - Drugs
2
Description
Control group: Randomly, 50 hospitalized newborns with jaundice in the control group will not be given probiotics and will only go through the course of treatment for jaundice in the hospital.