Cycled Phototherapy for Premature Infants
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants must stop taking their current medications.
What data supports the effectiveness of cycled phototherapy for premature infants?
How does cycled phototherapy differ from other treatments for premature infants?
Cycled phototherapy, also known as intermittent phototherapy, involves alternating periods of light exposure and darkness, which may help improve health outcomes in premature infants by mimicking natural day-night cycles. This approach is different from continuous phototherapy, which provides constant light exposure, and may offer practical benefits like improved feeding and bonding.678910
What is the purpose of this trial?
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (\< 750 g BW or \<27 weeks GA).
Research Team
Jon E. Tyson, MD MPH
Principal Investigator
The University of Texas Health Science Center, Houston
Eligibility Criteria
This trial is for extremely premature infants who weigh ≤ 750 grams or are born before 27 weeks of gestation. They must be between 12-36 hours old and born at the hospital conducting the study. Infants with previous phototherapy, certain blood conditions, infections, major anomalies, or those critically ill aren't eligible.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either cycled or continuous phototherapy based on randomization
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term follow-up
Participants are assessed for neurodevelopmental impairment
Treatment Details
Interventions
- Cycled Phototherapy
Cycled Phototherapy is already approved in United States, European Union for the following indications:
- Neonatal jaundice (hyperbilirubinemia) in extremely low birth weight infants
- Neonatal jaundice (hyperbilirubinemia) in preterm infants
Find a Clinic Near You
Who Is Running the Clinical Trial?
NICHD Neonatal Research Network
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator