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.
Eligible term neonates with indirect hyperbilirubinemia requiring phototherapy will be randomly assigned to either the intervention group or the control group. Neonates in the intervention group will receive oral Bifidobacterium animalis subsp. lactis (1 × 10⁹ CFU/day) in addition to standard phototherapy from the initiation of phototherapy until its discontinuation. Neonates in the control group will receive standard phototherapy alone according to the hospital protocol. All participants will undergo clinical evaluation and serum total bilirubin measurement before treatment and at day 3 of phototherapy. During hospitalization, the duration of phototherapy, length of hospital stay, serum bilirubin levels, and phototherapy-related adverse events will be recorded. Hospital readmission, including the occurrence, number, and primary reason for readmission, will be assessed at 28 days, 3 months, and 6 months of age.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
90
Standard phototherapy and oral Bifidobacterium animalis subsp. lactis (1 × 10⁹ CFU/day; 6 drops once daily)
Standard phototherapy without probiotic supplementation.
Can Tho University of Medicine and Pharmacy
Can Tho, Vietnam
Duration of phototherapy
The total duration of phototherapy, measured in hours
Time frame: From time of initiation of phototherapy until discontinuation of phototherapy, assessed up to 28 days of age
Change in serum total bilirubin level
The difference between serum total bilirubin levels measured before treatment initiation and at day 3 of treatment
Time frame: At baseline and day 3 of treatment
Length of hospitalization
The total length of hospitalization, measured in days
Time frame: From date of hospital admission until the date of hospital discharge, assessed up to 28 days of age
Adverse events
The occurrence of adverse events during treatment, including diarrhea, papular rash, dry skin with desquamation, hyperthermia, dehydration, and irritability
Time frame: From time of initiation of phototherapy until discontinuation of phototherapy, assessed up to 28 days of age
Rate of Hospital readmission
The proportion of participants who were readmitted to the hospital after discharge
Time frame: At 28 days, 3 months, and 6 months of age
Number of Hospital readmissions
Total number of hospital readmissions per participant
Time frame: At 28 days, 3 months, and 6 months of age
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