Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: October 1, 2017

Interventions

  • Drug: Probiotic
    • Probiotics drop

Arms, Groups and Cohorts

  • Active Comparator: Probiotic
    • Routine phototherapy plus probiotic oral drops at the dose of 10 drops daily
  • No Intervention: No probiotic
    • Routine phototherapy

Clinical Trial Outcome Measures

Primary Measures

  • Duration of phototherapy
    • Time Frame: 6 days
    • Duration of phototherapy

Secondary Measures

  • Discharge rate
    • Time Frame: 6 days
    • percentage of infants discharged from the hospital at 2nd, 3rd, 4th, and 5th days of admission

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 2 Days

Maximum Age: 28 Days

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Hormozgan University of Medical Sciences
  • Provider of Information About this Clinical Study
    • Principal Investigator: Hamidreza Mahboobi, Principle Investigator – Hormozgan University of Medical Sciences
  • Overall Official(s)
    • Rakhshaneh Goodarzi, M.D, Principal Investigator, Hormozgan University of Medical Sciences
  • Overall Contact(s)
    • Rakhshaneh Goodarzi, M.D, +989123004060, rakhshanehgoodarzi@yahoo.com

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