Cycled Phototherapy Study (CPT)

The Cycled Phototherapy Study aims to compare two different doses of phototherapy (continuous and cycled) in extremely preterm infants, focusing on babies ≤ 750g birthweight or gestational age < 27 weeks gestational age. Phototherapy, or light therapy, is a commonly used treatment to reduce bilirubin levels in the blood, which can cause brain damage if the bilirubin levels become too high.

Continuous phototherapy, where the treatment is administered continuously (60 mins per hour), has remained the standard approach in neonatal care for nearly five decades. However, recent studies have raised concerns about its safety, particularly in extremely premature infants, with continuous phototherapy increasing the risk of death in this population. These infants would normally undergo development in a dark environment within the womb for several more months before birth, making them potentially more vulnerable to the effects of continuous exposure to bright lights.

Cycled phototherapy offers an alternative approach to minimize unnecessary exposure to phototherapy lights among small, sick preterm babies. In this treatment, babies receive phototherapy for 15 minutes each hour, with the duration increased to 30 or 60 minutes only if needed to maintain bilirubin levels within a safe range.

By comparing continuous phototherapy with cycled phototherapy in this study, we aim to assess whether cycled phototherapy is effective in managing bilirubin levels while potentially reducing the risk of adverse effects associated with continuous exposure to phototherapy lights. This study may have significant future implications for the care and management of extremely preterm infants at risk of developing high bilirubin levels.

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Purpose & Aim

Population of the study: Extremely preterm infants <27 weeks’ gestation; or ≤750 grams birthweight
Intervention: Cycled Phototherapy for the treatment of elevated bilirubin
Control (Usual care in our hospital): Continuous Phototherapy
Outcome: Survival to discharge

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Trial Information

Target Enrollment: 1700
Funder: NIH NICHD Neonatal Research Network (NRN)
Duration of Study: June 2020 – September 2025

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Study Principal Investigator

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Links

ClinicalTrials.gov