Effectiveness of Phototherapy With and Without Probiotics

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

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.

Study Overview

• Status: Completed
• Conditions: Hyperbilirubinemia, Neonatal
• Intervention / Treatment: Other: LED phototherapy

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 Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Lahore, Pakistan, 54780
    • Humaira Waseem

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Phototherapy group; LED phototherapy (430-470nm)	Other: LED phototherapy; LED phototherapy (430-470nm) alone will be applied.
Experimental: phototherapy with probiotics group; 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; LED phototherapy (430-470nm) alone will be applied.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fatima Jinnah Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): October 10, 2022
• Study Completion (Actual): January 15, 2023

Study Registration Dates

• First Submitted: December 7, 2023
• First Submitted That Met QC Criteria: December 14, 2023
• First Posted (Estimated): December 18, 2023

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infant, Newborn, Diseases; Hyperbilirubinemia; Hyperbilirubinemia, Neonatal
• Other Study ID Numbers: KAU-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: when results are compiled

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No