Effectiveness of Phototherapy With and Without Probiotics

NCT06173856 | Completed

• 1 other identifier: KAU-1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperbilirubinemia, Neonatal

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Phototherapy group

ACTIVE COMPARATOR

LED phototherapy (430-470nm)

Other: LED phototherapy

phototherapy with probiotics group

EXPERIMENTAL

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

Interventions

LED phototherapy OTHER

LED phototherapy (430-470nm) alone will be applied.

Phototherapy group; phototherapy with probiotics group

Eligibility Criteria

• Age: 0 Hours - 1 Week
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• All the Neonates with indirect hyperbilirubinemia,
• Born at ;37 weeks of gestation
• Both male and female neonates were included in the study

You may not qualify if:

• Neonates with sepsis,
• bilirubin level in exchange transfusion range
• direct hyperbilirubinemia
• Neonates with respiratory distress syndrome, severe birth asphyxia, intubated and critically sick

Sponsors & Collaborators

• Fatima Jinnah Medical University: lead

Study Sites (1)

Humaira Waseem

Lahore, 54780, Pakistan

Location

MeSH Terms

Conditions

Hyperbilirubinemia, Neonatal

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperbilirubinemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 7, 2023
• First Posted: December 18, 2023
• Study Start: January 10, 2022
• Primary Completion: October 10, 2022
• Study Completion: January 15, 2023
• Last Updated: December 18, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)