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

ConditionIndirect Hyperbilirubinemia
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Bifidobacterium animalis subsp. lactis

    Drug

    Standard phototherapy and oral Bifidobacterium animalis subsp. lactis (1 × 10⁹ CFU/day; 6 drops once daily)

  • Standard Phototherapy

    Other intervention

    Standard phototherapy without probiotic supplementation.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Phototherapy and ProbioticsExperimental treatment 1 intervention
Group B: PhototherapyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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

Secondary outcomes

1

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
2

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
3

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
4

Number of Hospital readmissions

Total number of hospital readmissions per participant

Time frame
At 28 days, 3 months, and 6 months of age

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Can Tho University of Medicine and Pharmacy

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: