Comparison of the effect of probiotics vs. placebo in decreasing hospitalization duration in infants with hyperbilirubinaemia: a randomized clinical trial
The aim of the present study is to evaluate the effectiveness of probiotics in decreasing hospitalization duration in infants with hyperbilirubinaemia. So infants with gestational age of more than 35 weeks, birth weight more than 2500 gr and bilirubin level of more than 15 will be randomly assigned into two groups by a computer-generated randomization list; one with probiotics and other with placebo as well as common therapeutic methods like phototherapy. Afterward the effect of probiotics in decreasing hospitalization duration will be assessed in comparison with placebo. Septic and ill infants and those less than 2 days old will be excluded from study. Parents and nurse who was responsible for drug prescription were not informed about the ingredients of drugs and that which one are placebo and which ones are not.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015021817413N11
Registration date:2015-09-16, 1394/06/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-09-16, 1394/06/25
Registrant information
Name
Hamidreza Karimi-Sari
Name of organization / entity
Student Research Committee, Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8126 4354
Email address
hrkarimisari@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Baqiyatallah University of Medical Sciences, Deputy of Research
Expected recruitment start date
2015-07-10, 1394/04/19
Expected recruitment end date
2015-09-23, 1394/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of probiotics vs. placebo in decreasing hospitalization duration in infants with hyperbilirubinaemia: a randomized clinical trial
Public title
Use of probiotics in icter
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Gestational age of more than 35 weeks; birth weight of more than 2500 gr; serum level of bilirubin more than 15 mg/dL; direct bilirubin of less than 1.5 mg/dL. Exclusion criteria: Infants less than 2 days of age; ill and septic patients; infants with positive Coombs test; those undergoing blood exchange or IVIG and phenobarbital therapy; patients needing serum therapy.
Age
From 2 days old to 28 days old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Baqiyatallah University of Medical Sciences, Ethics Committee
Street address
Baqiyatallah University of Medical Sciences, South Sheykh Bahaei, Mollasadra st., Vanaq sq., Tehran, IR Iran
City
Tehran
Postal code
Approval date
2015-04-11, 1394/01/22
Ethics committee reference number
IR.BMSU.REC.1394.87
Health conditions studied
1
Description of health condition studied
Physiologic Jaundice
ICD-10 code
p59.9
ICD-10 code description
Physiological jaundice (intense)(prolonged) NOS
Primary outcomes
1
Description
Hospitalization duration
Timepoint
after beginning treatment till discharge
Method of measurement
Days Hospitalized after treatment
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: will be treated by a half capsule of Prokid probiotic once a day before breast feeding till discharge.
Category
Treatment - Drugs
2
Description
Control group: will use placebo, which is half capsule filled with probiotic-free formula with the same color as the Prokid probiotic, once a day before breast feeding till discharge.