Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

Phase 3

• Conditions: Hyperbilirubinemia, Neonatal
• Interventions: Drug: Probiotic

• Registration Number: NCT03266913
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-08
• Study Start: 2017-08-01
• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-08-29
• Last Update Submitted: 2017-08-29
• Study First Posted: 2017-08-30
• Last Update Posted: 2017-08-30
• Primary Completion: 2017-10-01
• Study Completion: 2017-11-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 126

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic	Routine phototherapy plus probiotic oral drops at the dose of 10 drops daily

Primary Outcome Measures

Name	Time	Method
Duration of phototherapy	6 days	Duration of phototherapy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children hospital; 🇮🇷 Bandar Abbas, Hormozgan, Iran, Islamic Republic of