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Completed

NCT Number: NCT06173856

Effectiveness of Phototherapy With and Without Probiotics

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.

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Key information

Conditions

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

Age range

0 hour–1 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Humaira Waseem

Lahore, 54780, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LED phototherapy

Other

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

Primary outcomes

  1. effectiveness

    Time frame: 1 to 2 weeks

    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

Sponsors and collaborators

Lead sponsor

Fatima Jinnah Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Dec 18, 2023
Registry last updated
Dec 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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