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Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03266913
Recruitment Status : Unknown
Verified August 2017 by Hamidreza Mahboobi, Hormozgan University of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : August 30, 2017
Last Update Posted : August 30, 2017
Information provided by (Responsible Party):
Hamidreza Mahboobi, Hormozgan University of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Hyperbilirubinemia, Neonatal Drug: Probiotic Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : October 1, 2017
Estimated Study Completion Date : November 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Jaundice

Arm Intervention/treatment
Active Comparator: Probiotic
Routine phototherapy plus probiotic oral drops at the dose of 10 drops daily
Drug: Probiotic
Probiotics drop
Other Name: PediLact

No Intervention: No probiotic
Routine phototherapy

Primary Outcome Measures :
  1. Duration of phototherapy [ Time Frame: 6 days ]
    Duration of phototherapy

Secondary Outcome Measures :
  1. Discharge rate [ Time Frame: 6 days ]
    percentage of infants discharged from the hospital at 2nd, 3rd, 4th, and 5th days of admission

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03266913

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Contact: Rakhshaneh Goodarzi, M.D +989123004060

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Iran, Islamic Republic of
Children hospital Recruiting
Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 763
Contact: Rakhshaneh Goodarzi    +989123004060   
Sponsors and Collaborators
Hormozgan University of Medical Sciences
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Principal Investigator: Rakhshaneh Goodarzi, M.D Hormozgan University of Medical Sciences

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Responsible Party: Hamidreza Mahboobi, Principle Investigator, Hormozgan University of Medical Sciences Identifier: NCT03266913     History of Changes
Other Study ID Numbers: 4889
First Posted: August 30, 2017    Key Record Dates
Last Update Posted: August 30, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Hyperbilirubinemia, Neonatal
Pathologic Processes
Infant, Newborn, Diseases