Efficacy and Safety of Probiotics in Neonatal Hyperbilirubinemia

Hormozgan University of Medical Sciences

Status and phase: Unknown; Phase 3

Conditions: Hyperbilirubinemia, Neonatal

Treatments: Drug: Probiotic

Study type: Interventional

Funder types: Other

Identifiers

NCT03266913

4889

Details and patient eligibility

About

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.

Enrollment: 126 estimated patients

Sex: All

Ages: 2 to 28 days old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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126 participants in 2 patient groups

Probiotic

Active Comparator group

Description:

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

Treatment:

Drug: Probiotic

No probiotic

No Intervention group

Description:

Routine phototherapy