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Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

Primary Purpose

Hyperbilirubinemia, Neonatal

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Probiotic
Sponsored by
Hormozgan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperbilirubinemia, Neonatal

Eligibility Criteria

2 Days - 28 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Between 2 and 28 days old
  • Having jaundice
  • Gestational age between 35-42 weeks

Exclusion Criteria:

  • Less than 2 days or more than 28 days old
  • Gestational age out of the range of 35-42 weeks
  • Infants whose parents refused to cooperate
  • Patients with sepsis and other comorbid conditions

Sites / Locations

  • Children hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Probiotic

No probiotic

Arm Description

Routine phototherapy plus probiotic oral drops at the dose of 10 drops daily

Routine phototherapy

Outcomes

Primary Outcome Measures

Duration of phototherapy
Duration of phototherapy

Secondary Outcome Measures

Discharge rate
percentage of infants discharged from the hospital at 2nd, 3rd, 4th, and 5th days of admission

Full Information

First Posted
August 28, 2017
Last Updated
August 29, 2017
Sponsor
Hormozgan University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT03266913
Brief Title
Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia
Official Title
Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
October 1, 2017 (Anticipated)
Study Completion Date
November 1, 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hormozgan University of Medical Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Neonatal Jaundice occurs in 60% of term infants and 80% of premature infants. Although it is transient, it is associated with high rate of readmission of patients in the first week of infancy. Neonatal jaundice can cause neurological complications and kernicterus. Considering the fact that there have been a lot of studies on probiotic role in management of necrotizing enterocolitis (NEC) and few studies on their role in neonatal jaundice, we carried out this study to determine the efficacy and safety of probiotics in neonatal hyperbilirubinemia in infants hospitalized in children hospital in Bandar Abbas.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperbilirubinemia, Neonatal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Active Comparator
Arm Description
Routine phototherapy plus probiotic oral drops at the dose of 10 drops daily
Arm Title
No probiotic
Arm Type
No Intervention
Arm Description
Routine phototherapy
Intervention Type
Drug
Intervention Name(s)
Probiotic
Other Intervention Name(s)
PediLact
Intervention Description
Probiotics drop
Primary Outcome Measure Information:
Title
Duration of phototherapy
Description
Duration of phototherapy
Time Frame
6 days
Secondary Outcome Measure Information:
Title
Discharge rate
Description
percentage of infants discharged from the hospital at 2nd, 3rd, 4th, and 5th days of admission
Time Frame
6 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Days
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between 2 and 28 days old Having jaundice Gestational age between 35-42 weeks Exclusion Criteria: Less than 2 days or more than 28 days old Gestational age out of the range of 35-42 weeks Infants whose parents refused to cooperate Patients with sepsis and other comorbid conditions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rakhshaneh Goodarzi, M.D
Phone
+989123004060
Email
rakhshanehgoodarzi@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakhshaneh Goodarzi, M.D
Organizational Affiliation
Hormozgan University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children hospital
City
Bandar Abbas
State/Province
Hormozgan
ZIP/Postal Code
763
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rakhshaneh Goodarzi
Phone
+989123004060
Email
rakhshanehgoodarzi@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

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