Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

NCT ID: NCT03266913

Last Updated: 2017-08-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2017-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Hyperbilirubinemia, Neonatal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Probiotic

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

Group Type ACTIVE_COMPARATOR

Probiotic

Intervention Type DRUG

Probiotics drop

No probiotic

Routine phototherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Probiotic

Probiotics drop

Intervention Type DRUG

Other Intervention Names

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PediLact

Eligibility Criteria

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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
Minimum Eligible Age

2 Days

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hormozgan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Hamidreza Mahboobi

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rakhshaneh Goodarzi, M.D

Role: PRINCIPAL_INVESTIGATOR

Hormozgan University of Medical Sciences

Locations

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Children hospital

Bandar Abbas, Hormozgan, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Rakhshaneh Goodarzi, M.D

Role: CONTACT

+989123004060

Facility Contacts

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Rakhshaneh Goodarzi

Role: primary

+989123004060

Other Identifiers

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4889

Identifier Type: -

Identifier Source: org_study_id

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