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NCT07773012
Efficacy of Bifidobacterium Animalis Subsp. Lactis in the Treatment of Indirect Hyperbilirubinemia in Term Neonates
Conditions: Indirect Hyperbilirubinemia
Sex: All
Ages: N/A – 28 Days
Healthy volunteers: No
Phase: NA
Enrollment: 90
Sponsor: Can Tho University of Medicine and Pharmacy
Location: Can Tho University of Medicine and Pharmacy Can Tho
Summary
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
Inclusion Criteria:
* 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
* Informed consent obtained from a parent or legal guardian.
Exclusion Criteria:
* 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.
* Suspected gastrointestinal obstruction.
* Unable to tolerate oral feeding.
Source: ClinicalTrials.gov (NCT07773012). StuddyBuddy aggregates publicly available trial information.