Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 28
SponsorCan Tho University of Medicine and Pharmacy

About this trial

This study aims to evaluate the effectiveness of adjunctive oral Bifidobacterium animalis subsp. lactis in term neonates with indirect hyperbilirubinemia receiving phototherapy. The study will compare the effects of adjunctive probiotics plus standard phototherapy with standard phototherapy alone on the duration of phototherapy, length of hospital stay, serum total bilirubin reduction, phototherapy-related adverse events, and hospital readmission after discharge.

Eligibility criteria

Qualifiers

Age from 0-28 days.

Gestational age 37-42 weeks.

Diagnosed with indirect hyperbilirubinemia according to the AAP 2022 guidelines.

Eligible for phototherapy based on serum total bilirubin levels

Disqualifiers

Direct hyperbilirubinemia (direct bilirubin >2.0 mg/dL and >20% of total serum bilirubin).

Major congenital anomalies or severe concurrent illness (e.g., respiratory failure, intracranial hemorrhage).

Indication for exchange transfusion, intravenous immunoglobulin (IVIG) or phenobarbital according to the AAP 2022 guidelines.

Neonatal sepsis, blood group incompatibility, glucose-6-phosphate dehydrogenase deficiency, red blood cell membrane disorders.

Trial design

Treatments tested in this trial

  • Bifidobacterium animalis subsp. lactis
  • Standard Phototherapy

Treatment groups

90 Participants
are divided into 2 treatment groups