Indirect Hyperbilirubinemia
Conditions
Keywords
Neonatal jaundice, Indirect hyperbilirubinemia, Phototherapy, Probiotics
Brief 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.
Detailed description
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.
Interventions
Standard phototherapy and oral Bifidobacterium animalis subsp. lactis (1 × 10⁹ CFU/day; 6 drops once daily)
Standard phototherapy without probiotic supplementation.
Sponsors
Can Tho University of Medicine and Pharmacy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 28 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of phototherapy | From time of initiation of phototherapy until discontinuation of phototherapy, assessed up to 28 days of age | The total duration of phototherapy, measured in hours |
| Change in serum total bilirubin level | At baseline and day 3 of treatment | The difference between serum total bilirubin levels measured before treatment initiation and at day 3 of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospitalization | From date of hospital admission until the date of hospital discharge, assessed up to 28 days of age | The total length of hospitalization, measured in days |
| Adverse events | From time of initiation of phototherapy until discontinuation of phototherapy, assessed up to 28 days of age | The occurrence of adverse events during treatment, including diarrhea, papular rash, dry skin with desquamation, hyperthermia, dehydration, and irritability |
| Rate of Hospital readmission | At 28 days, 3 months, and 6 months of age | The proportion of participants who were readmitted to the hospital after discharge |
| Number of Hospital readmissions | At 28 days, 3 months, and 6 months of age | Total number of hospital readmissions per participant |
Countries
Vietnam
Contacts
CONTACTTam Thi Ngan Hua, MD
CONTACTDuc Long Tran, PhD
PRINCIPAL_INVESTIGATORTam Thi Ngan Hua, MD
Can Tho University of Medicine and Pharmacy
Outcome results
None listed