CTRI/2024/04/065593
Not yet recruiting
Phase 4
To study the efficacy of Probiotics along with Phototherapy and phototherapy alone in neonatal hyperbilirubinemia: A Randomized Controlled Trial
Government Medical College Rajindra Hospital Patiala1 site in 1 country150 target enrollmentStarted: April 26, 2024Last updated:
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Government Medical College Rajindra Hospital Patiala
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- serum bilirubin level lowering efficacy of probiotics along with phototherapy vs phototheray alone in patients of neonatal hyperbilirubinemia
Overview
Brief Summary
This will be a randomized clinical trial including 150 neonates diagnosed with neonatal hyperbilirubinemia. Patients will be randomized to two groups - phototherapy with oral probiotics (Darolac) and phototherapy alone through stratified randomization. Serum Bilirubin Levels (SBL) at the time of intervention, 24, 48, and 72 hours later, duration of phototherapy, duration of hospitalization, and any side effect related to intervention will be assessed and compared in the two groups
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 1.00 Day(s) to 21.00 Day(s) (—)
- Sex
- All
Inclusion Criteria
- •Preterm and term neonates with hyperbilirubinemia (35-40 weeks)
- •Patients with jaundice due to maternal blood type ABO compatibility
- •G6PD deficiency
- •Hypothyroidism 5.
Exclusion Criteria
- •Patients with gestational age less than 35 weeks.
- •Patients with severe cardiopulmonary illness.
- •Patients with birth weight less than 2,000 grams.
- •Patients having signs of perinatal asphyxia.
- •Patients with congenital anomalies.
- •Patients whose parents refuse to give written informed consent.
Outcomes
Primary Outcomes
serum bilirubin level lowering efficacy of probiotics along with phototherapy vs phototheray alone in patients of neonatal hyperbilirubinemia
Time Frame: Day-1, 24 hours, 48 hours and 72 hours
Secondary Outcomes
- change in duration of phototherapy in probiotics along with phototherapy and phototherapy alone treatment group(Day-1, 24 hours, 48 hours and 72 hours)
Investigators
Dr Amanpreet Kaur
Government Medical College & Rajindra Hospital Patiala
Study Sites (1)
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