IRCT | Therapeutic effects of Synbiotics plus phototherapy on decreasing bilirubin level in 3-14 day old icteric Neonates with gestational age >35 weeks and comparison with only phototherapy theraputic effect

Protocol summary

Study aim: Our objective is evaluation of therapeutic effects of Synbiotics plus routine phototherapy on decreasing bilirubin and duration of admission and defecation numbers in term icteric neonates with > 35 weeks GA and compare the results with icteric neonates under routine phototherapy without Synbiotic adminstration.
Design: Our study is a randomized, double-blind trial. 194 neonates participate in our study ( 97 neonates in each group). The patients are randomly divided in to two groups through block randomization using blocks of size 4. Intervention group will be treated by 5 drops of pedilact in addition to daily phototherapy. Control group will be given 5 drops of placebo every day in addition to phototherapy. The level of bilirubin will be measured daily until the day of discharge. The frequency of defecation and any complication will be recorded.
Settings and conduct: Our double blind randomized study will be done at Rasht 17 Shahrivar hospital, after obtaining informed consent from parents. Patients and parents will be unaware of the type of prescribed drug.
Participants/Inclusion and exclusion criteria: Inclusion Criteria: Gestational age > 35 weeks; being at the age of 3-14 days; weight > 2500 gr; total Bilirubin between 15-22; exclusive breast feeding Exclusion criteria: Sepsis; underlying disease; diabetes in mother; treated by phenobarbital or bilinaster; family history of immune deficiency; treated by antibiotics.
Intervention groups: Intervention group will be treated with daily Synbiotic (Pedi-lact) oral drop and routine phototherapy. The control group will only receive phototherapy (without Synbiotics).
Main outcome variables: Bilirubin Level in Admission Day and Daily to Discharge.Defecation Number and stool consistency ;Duration of Phototherapy And Admission.

General information

Reason for update
Acronym
IRCT registration information: IRCT registration number: IRCT20180228038895N1

Registration date: 2018-09-26, 1397/07/04

Registration timing: prospective

Last update: 2018-09-26, 1397/07/04

Update count: 0
Registration date: 2018-09-26, 1397/07/04

Registrant information: Name

Seyedeh Azadeh Hosseini Nouri

Name of organization / entity

Country

Iran (Islamic Republic of)

Phone

+98 13 3336 9026

Email address

dr.azadehoseini@gums.ac.ir

Recruitment status: Recruitment complete
Funding source

Expected recruitment start date: 2018-10-12, 1397/07/20
Expected recruitment end date: 2019-10-12, 1398/07/20
Actual recruitment start date: empty
Actual recruitment end date: empty
Trial completion date: empty

Scientific title: Therapeutic effects of Synbiotics plus phototherapy on decreasing bilirubin level in 3-14 day old icteric Neonates with gestational age >35 weeks and comparison with only phototherapy theraputic effect

Public title: Effect of Synbiotics on Neonatal hyperbilirubinemia
Purpose: Treatment
Inclusion/Exclusion criteria: Inclusion criteria:

Age between 3-14 days Total bilirubin between 15-22 mg/dl and direct bill <1.5 Exclusive breast feeding Without underlying disease Weight>2500gr

Exclusion criteria:

Sepsis Cephalhematoma ABO incompatibility G6PD deficiency Underlying disease Parental dissatisfaction Polycythemia RH incompatibility Formula feeding Treated by Phenobarbital .billinaster.etc... Transfer to NICU Down Syndrome Family history of Immune deficiency Blood exchange Treated by Antibiotics Serum therapy Hemolysis Diabetes in Mother
Age: From 3 days old to 14 days old
Gender: Both

Phase

3

Groups that have been masked

Participant
Investigator
Outcome assessor
Data analyser

Sample size

Target sample size: 194

Randomization (investigator's opinion)

Randomized

Randomization description

Random assignment will be based on random blocks of size 4

Blinding (investigator's opinion)

Double blinded

Blinding description

In this Study, the parents of participants are unaware of the type of drug used (synbiotic or placebo).The main investigator is blind. One of the personnel is reponsible for prescribe and secretly record the type of medication.Residents and other nurses are responsible for collecting data.The data analyst also announces the results in terms of group A, B. The person who evaluate effect of Synbiotic also has no information on the type of prescription drug in every patient.

Placebo

Used

Assignment

Parallel

Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee: Name of ethics committee

Ethics committee of Guilan University Of Medical Sciences

Street address

Siadati Ave, Namjoo Blvd

City

Rasht

Province

Guilan

Postal code

441774349
Approval date: 2018-07-26, 1397/05/04
Ethics committee reference number: IR.GUMS.REC.1397.196

Health conditions studied

1

Description of health condition studied: neonatal hyperbilirubinemia and symbiotic effect on its treatment
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description: Bilirubin level
Timepoint: Measurement of Bilirubin in admission day and daily until discharge(8 AM)
Method of measurement: Measurement of serum bilirubin in laboratory by Pars Azmoon kits

Secondary outcomes

1

Description: daily defecation numbers
Timepoint: Daily at 8 AM until discharge
Method of measurement: Question from parents

Intervention groups

1

Description: Intervention group will receive 5 drops of oral Pedilact before breast feeding, once a day, until the day of discharge in addition to routine phototherapy,. Pedilact is a Synbiotic and contains three types of probiotic including Lactobacillus rotieri, Lactobacillus romansus and Bifidobacterium infantis and a prebiotic. It is produced by Iran zist takhmir Company
Category: Treatment - Drugs

2

Description: Control group will receive five drops of diluted formulas once a day as placebo before breastfeeding until the day of discharge in addition to routine phototherapy.
Category: Placebo

Recruitment centers

1

Recruitment center: Name of recruitment center

17 Shahrivar Hospital.

Full name of responsible person

Seyedeh Azadeh Hosseini Nouri

Street address

Siadati Alley, Namjoo St, Gaz Square

City

Rasht

Province

Guilan

Postal code

000000000000

Phone

+98 13 3336 9026

Email

dr.azadehoseini@gums.ac.ir

1

Sponsor: Name of organization / entity

Rasht University of Medical Sciences

Full name of responsible person

Shadman Nemati

Street address

Research Deputy, Siadati Alley. Namjoo Street. Gaz Square

City

Rasht

Province

Guilan

Postal code

00000000000000000000

Phone

+98 13 3336 9026

Email

dr.azadehoseini@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?: Yes
Title of funding source: Rasht 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

Rasht University of Medical Sciences

Full name of responsible person

Seyedeh Azadeh Hosseini Nouri

Position

Assistant Professor of Medical University

Latest degree

Specialist

Other areas of specialty/work

Pediatrics

Street address

Siadati Alley. Namjoo Street. Gaz Square

City

Rasht

Province

Guilan

Postal code

000000000000

Phone

+98 13 3336 9026

Email

dr.azadehoseini@gums.ac.ir

Person responsible for scientific inquiries

Contact: Name of organization / entity

Rasht University of Medical Sciences

Full name of responsible person

Seyedeh Azadeh Hosseini Nouri

Position

Assistant Professor of Medical University

Latest degree

Specialist

Other areas of specialty/work

Pediatrics

Street address

Siadati Alley. Namjoo Street. Gaz Square

City

Rasht

Province

Guilan

Postal code

0000000000

Phone

+98 13 3336 9026

Email

dr.azadehoseini@gums.ac.ir

Person responsible for updating data

Contact: Name of organization / entity

Rasht University of Medical Sciences

Full name of responsible person

Seyedeh Azadeh Hosseini Nouri

Position

Assistant Professor of Medical University

Latest degree

Specialist

Other areas of specialty/work

Pediatrics

Street address

Siadati Alley. Namjoo Street. Gaz Square

City

Rasht

Province

Guilan

Postal code

000000000

Phone

+98 13 3336 9026

Email

dr.azadehoseini@gums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD): Undecided - It is not yet known if there will be 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: Undecided - It is not yet known if there will be 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

Therapeutic effects of Synbiotics plus phototherapy on decreasing bilirubin level in 3-14 day old icteric Neonates with gestational age >35 weeks and comparison with only phototherapy theraputic effect