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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Hyperbilirubinemia, Neonatal

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