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NCT06173856 Clinical Trial

Effectiveness of Phototherapy With and Without Probiotics

Hyperbilirubinemia, Neonatal Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06173856
Other study ID # KAU-1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 10, 2022
Est. completion date January 15, 2023

Study information
Verified date December 2023
Source Fatima Jinnah Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 76
Est. completion date January 15, 2023
Est. primary completion date October 10, 2022
Accepts healthy volunteers No
Gender All
Age group 0 Hours to 1 Week
Eligibility 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

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Pakistan Humaira Waseem Lahore

Sponsors (1)
Lead Sponsor Collaborator
Fatima Jinnah Medical University

Country where clinical trial is conducted

Pakistan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
See also
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Completed NCT01763632 - Development of TcB Nomogram to Identify Neonatal Hyperbilirubinemia in Term and Late-preterm Infants N/A
Completed NCT01762189 - The Incidence and Risk Factors of Neonatal Hyperbilirubinemia in Term and Late-preterm Chinese Infants N/A