Effectiveness of Phototherapy With and Without Probiotics

Study Overview
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Brief Summary
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Raised serum bilirubin levels can cause kernicterus and premature infants are at increased risk due to metabolic immaturity. The standard treatment for neonatal jaundice is phototherapy but probiotics along with it can reduce the duration of phototherapy and hospitalization stay, secondarily can reduce the risk of nosocomial infection.

Detailed Description
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Raised serum bilirubin levels can cause kernicterus and premature infants are at increased risk due to metabolic immaturity. The comparative analytical study was conducted after the ethical approval for one year (Jan 2022-Jan 2023) in the neonatal unit of The University of Lahore Teaching Hospital, Lahore, Pakistan. 76 preterm neonates fulfilling the selection criteria were included in the study and divided into two groups. Standard phototherapy was applied in both groups and group A probiotic (Saccharomyces boulardii) 125mg, twice daily, orally (in 5cc of milk whichever the baby was taking) was given till discharge from the hospital. The primary outcome measurements were the duration of phototherapy and the length of hospitalization.

Official Title
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Effectiveness of Phototherapy With and Without Probiotics for the Treatment of Indirect Hyperbilirubinemia in Preterm Neonates

Conditions
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Hyperbilirubinemia, Neonatal

Intervention / Treatment
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* Other: LED phototherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All the Neonates with indirect hyperbilirubinemia, Born at ;37 weeks of gestation Both male and female neonates were included in the study Exclusion Criteria: Neonates with sepsis, bilirubin level in exchange transfusion range direct hyperbilirubinemia Neonates with respiratory distress syndrome, severe birth asphyxia, intubated and critically sick

Ages Eligible for Study
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Minimum Age: 0 Hours
Maximum Age: 1 Week

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Phototherapy group<br>LED phototherapy (430-470nm) | Other: LED phototherapy<br>* LED phototherapy (430-470nm) alone will be applied.<br>|
| Experimental: phototherapy with probiotics group<br>In group B, LED phototherapy (430-470nm) with probiotics (125mg Saccharomyces boulardii, twice a day, orally mixed in 5cc of milk whichever the neonate is taking). | Other: LED phototherapy<br>* LED phototherapy (430-470nm) alone will be applied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effectiveness | mean duration of phototherapy and the mean duration of hospital stay with and without probiotics for treatment of indirect hyerbilirubinemia in preterm neonates probiotics for the treatment of indirect hyperbilirubinemia in preterm neonates | 1 to 2 weeks |