Cycled Phototherapy
20 other identifiers
interventional
1,700
1 country
19
Brief Summary
Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (\< 750 g BW or \<27 weeks GA).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2020
Longer than P75 for not_applicable
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 18, 2019
CompletedFirst Posted
Study publicly available on registry
April 25, 2019
CompletedStudy Start
First participant enrolled
July 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 4, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2027
ExpectedDecember 18, 2025
December 1, 2025
5.3 years
April 18, 2019
December 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants survival to discharge
Number of Participants discharged from hospital alive, after birth.
Birth to hospital discharge, up to 120 days of life
Secondary Outcomes (14)
Number of hours of Phototherapy
Start until the end of intervention period (duration of 2 weeks)
Number of irradiance hours
Start until the end of intervention period (duration of 2 weeks)
Peak Concentration of Total Serum Bilirubin
Start until the end of intervention period (duration of 2 weeks)
Concentration of Total Serum Bilirubin
Start until the end of intervention period (duration of 2 weeks)
Number of Participants with Major neonatal morbidity
Birth to hospital discharge, up to 120 days of life
- +9 more secondary outcomes
Study Arms (2)
Continuous Phototherapy
ACTIVE COMPARATORContinuous phototherapy
Cycled Phototherapy
EXPERIMENTALCycled phototherapy at timed intervals, dependent upon total serum bilirum (TSB) levels.
Interventions
Phototherapy lights used continuously or timed, following an algorithm based upon TSB levels.
Eligibility Criteria
You may qualify if:
- Infants is inborn
- Infant is ≤ 750 grams at birth and/or \< 27 weeks gestation at birth by best OB estimate
- Infant is 12-36 hours of age.
You may not qualify if:
- Unable to enroll infant by 36 hours of age
- Previous phototherapy
- Known hemolytic disease
- TSB reported as \>6.0 mg/dL before 12 hours age
- Major anomaly
- Overt nonbacterial infection
- Infant is likely to expire soon: Limiting or withdrawal of intensive care is being recommended to the parents, the parents are requesting withdrawal of care, or the pH is \< 6.80 or persistent bradycardia with hypoxemia for \>2h.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Stanford University
Palo Alto, California, 94304, United States
Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123, United States
Emory University
Atlanta, Georgia, 30303, United States
Northwestern Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
University of Iowa
Iowa City, Iowa, 52242, United States
University of Mississippi Medical Center - Children's of Mississippi
Jackson, Mississippi, 39216, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
University of Rochester
Rochester, New York, 14642, United States
RTI International
Durham, North Carolina, 27705, United States
Duke University
Durham, North Carolina, 27710, United States
Cincinnati Children's Medical Center
Cincinnati, Ohio, 45267, United States
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106, United States
Research Institute at Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
Univeristy of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Brown University - Women and Infants Hospital of Rhode Island
Providence, Rhode Island, 02905, United States
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
University of Texas Health Science Center at Houston
Houston, Texas, 77030, United States
University of Utah
Salt Lake City, Utah, 84108, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon Tyson, MD
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NETWORK
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 18, 2019
First Posted
April 25, 2019
Study Start
July 16, 2020
Primary Completion
November 4, 2025
Study Completion (Estimated)
July 31, 2027
Last Updated
December 18, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
NIH has had a long-standing policy to share and make available to the public the results and accomplishments of the activities that it funds. The NRN plans to share de-identified data after final publication in an NIH supported data repository such as the NICHD Data and Specimen Hub (https://dash.nichd.nih.gov)