Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

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 Overview

• Status: Unknown
• Conditions: Hyperbilirubinemia, Neonatal
• Intervention / Treatment: Drug: Probiotic

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Phase 3

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Hormozgan
    • Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 763
      • Recruiting
      • Children Hospital
      • Contact: Rakhshaneh Goodarzi; Phone Number: +989123004060; Email: rakhshanehgoodarzi@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Probiotic; Routine phototherapy plus probiotic oral drops at the dose of 10 drops daily	Drug: Probiotic; Probiotics drop; Other Names: PediLact
No Intervention: No probiotic; Routine phototherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of phototherapy	Duration of phototherapy	6 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hormozgan University of Medical Sciences
• Investigators: Principal Investigator: Rakhshaneh Goodarzi, M.D, Hormozgan University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Anticipated): October 1, 2017
• Study Completion (Anticipated): November 1, 2017

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 29, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): August 30, 2017
• Last Update Submitted That Met QC Criteria: August 29, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: 4889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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