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Effectiveness of Phototherapy With and Without Probiotics

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06173856
Enrollment
76
Registered
2023-12-18
Start date
2022-01-10
Completion date
2023-01-15
Last updated
2023-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperbilirubinemia, Neonatal

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.

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.

Interventions

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

Sponsors

Fatima Jinnah Medical University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
0 Hours to 1 Weeks
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
effectiveness1 to 2 weeksmean 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

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026