Effectiveness of Phototherapy With and Without Probiotics

Fatima Jinnah Medical University

Status: Completed

Conditions: Hyperbilirubinemia, Neonatal

Treatments: Other: LED phototherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06173856

KAU-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 patients

Sex: All

Ages: Under 1 week old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

Phototherapy group

Active Comparator group

Description:

LED phototherapy (430-470nm)

Treatment:

Other: LED phototherapy

phototherapy with probiotics group

Experimental group

Description:

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).

Treatment:

Other: LED phototherapy