The design of an experimental study is to investigate the effect of probiotics on the duration of treatment of neonatal jaundice in gestational age of 37-42 weeks. Infants with infections, thyroid problems, and history of any blood product injection are excluded from the study.The study population was infants admitted to NICU1 and NICU2 in Kamali hospital, Karaj, Iran. The sample size was 45 in each intervention and control group. In the first step, the neonate bilirubin is checked using a serum sample in the laboratory. Then, they are randomly divided into two groups of intervention and control (paired up / individual). In the intervention group, 1 cc of probiotic lactoasidophilus is added to the two daily meals. Bilirubin is checked daily and recorded in a table. Then, the collected data are analyzed using statistical tests. Finally, the results are compared with the amount of bilirubin changes in the two groups, as well as the duration of hospitalization of these infants.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017042733661N1
Registration date:2017-06-30, 1396/04/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-06-30, 1396/04/09
Registrant information
Name
Alireza Jashnimotlagh
Name of organization / entity
Alborz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3222 2021
Email address
dr.jashnimotlagh@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Alborz University of Medical Sciences
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Probiotics in duration of treatment of neonetal jaundice with 42-37 weeks gestational age
Public title
The effect of Probiotics in treatment of neonetal jaundice
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: gestational age (42-37 weeks); jaundice (physiological and non-physiological).
Exclusion criteria:Infection; SEPSIS; Hypothyroidism; History the blood transfusion.
Age
From 1 day old to 28 days old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Alborz University of Medical Science
Street address
Alborz University of Medical Science, Office Park, Taleghani Square, Azimieh
City
Karaj
Postal code
-
Approval date
2016-12-24, 1395/10/04
Ethics committee reference number
Abzums.rec.1395.48
Health conditions studied
1
Description of health condition studied
Neonatal Jaundice
ICD-10 code
P00
ICD-10 code description
Newborn/ Neonatal Diagnoses
2
Description of health condition studied
Neonatal Jaundice
ICD-10 code
P96
ICD-10 code description
Newborn/ Neonatal Diagnosis
Primary outcomes
1
Description
Neonatal Jaundice
Timepoint
Dqily
Method of measurement
Blood test
Secondary outcomes
1
Description
Duration of treatment of Neonatal Jaundice
Timepoint
Discharge Time
Method of measurement
The number of days of hospitalization records
Intervention groups
1
Description
Intervention group: 1 cc Probiotics will be added totwice of the milk of their daily milk( Lactobacillus with 10*9 colonies).