Effectiveness of Phototherapy With and Without Probiotics

Not Applicable

Completed

• Conditions: Hyperbilirubinemia, Neonatal
• Interventions: Other: LED phototherapy

• Registration Number: NCT06173856
• Lead Sponsor: Fatima Jinnah Medical University

Brief Summary

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

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.

Study Timeline

• Study Start: 2022-01-10
• Primary Completion: 2022-10-10
• Study Completion: 2023-01-15
• Status Verified: 2023-12
• Study First Submitted: 2023-12-07
• Study First Submitted QC: 2023-12-14
• Last Update Submitted: 2023-12-14
• Study First Posted: 2023-12-18
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phototherapy group	LED phototherapy	LED phototherapy (430-470nm)
phototherapy with probiotics group	LED phototherapy	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).

Primary Outcome Measures

Name	Time	Method
effectiveness	1 to 2 weeks	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

Trial Locations

Locations (1)

Humaira Waseem; 🇵🇰 Lahore, Pakistan