Cycled Phototherapy: A Safer Effective Treatment for Small Premature Infants?
1 other identifier
interventional
210
1 country
6
Brief Summary
Cycled (intermittent) phototherapy will be compared to continuous (uninterrupted) phototherapy in the treatment of hyperbilirubinemia (newborn jaundice) in extremely low birth weight newborns in a pilot randomized controlled trial. Hypothesis: Cycled phototherapy (PT) will provide the same benefits as continuous phototherapy in extremely low birth weight (ELBW) infants without the risks that have been associated with continuous phototherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2014
Longer than P75 for not_applicable
6 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
September 12, 2013
CompletedFirst Posted
Study publicly available on registry
September 18, 2013
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2018
CompletedJune 16, 2016
June 1, 2016
2.8 years
September 12, 2013
June 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain stem auditory evoked response wave V latency
a measure of transient or permanent bilirubin neurotoxicity
35 wks postmenstrual age or discharge
Secondary Outcomes (1)
Peak Total Serum Bilirubin (tsb)
14 days from birth
Other Outcomes (2)
Neurodevelopmental status
2 years adjusted age
Survival
Before discharge from the neonatal ICU and at 2 years adjusted age
Study Arms (2)
continuous (uninterrupted) phototherapy
ACTIVE COMPARATORstandard phototherapy
15 minute per hour cycled phototherapy
EXPERIMENTAL15 minute per hour cycled phototherapy
Interventions
Cycled versus continuous phototherapy during the first 2 wks after birth, both administered at bilirubin thresholds used in the NICHD Neonatal Network Phototherapy trial .
Eligibility Criteria
You may qualify if:
- birth weight 401-1000 grams
- age less than or equal to 24 hours
You may not qualify if:
- hemolytic disease
- major anomaly
- overt nonbacterial infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Texas Health Science Center, Houstonlead
- Stanford Universitycollaborator
- Lucile Packard Children's Hospitalcollaborator
Study Sites (6)
University of Alabama at Birmingham School of Medicine - UAB Hospital
Birmingham, Alabama, 35233, United States
Stanford University - Lucile Packard Children's Hospital
Palo Alto, California, 94304, United States
University of Cincinnati College of Medicine - Good Samaritan Hospital
Cincinnati, Ohio, 45220, United States
The University of Texas Southwestern Medical School - Clements University Hospital
Dallas, Texas, 75390, United States
The University of Texas Health Science Center at Houston; Memorial Hermann-TMC-NICU
Houston, Texas, 77030, United States
The University of Texas Health Science Center at San Antonio - University Hospital
San Antonio, Texas, 78229, United States
Related Publications (3)
Tyson JE, Pedroza C, Langer J, Green C, Morris B, Stevenson D, Van Meurs KP, Oh W, Phelps D, O'Shea M, McDavid GE, Grisby C, Higgins R; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Does aggressive phototherapy increase mortality while decreasing profound impairment among the smallest and sickest newborns? J Perinatol. 2012 Sep;32(9):677-84. doi: 10.1038/jp.2012.64. Epub 2012 May 31.
PMID: 22652561BACKGROUNDHintz SR, Stevenson DK, Yao Q, Wong RJ, Das A, Van Meurs KP, Morris BH, Tyson JE, Oh W, Poole WK, Phelps DL, McDavid GE, Grisby C, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Is phototherapy exposure associated with better or worse outcomes in 501- to 1000-g-birth-weight infants? Acta Paediatr. 2011 Jul;100(7):960-5. doi: 10.1111/j.1651-2227.2011.02175.x. Epub 2011 Feb 25.
PMID: 21272067BACKGROUNDArnold C, Tyson JE, Pedroza C, Carlo WA, Stevenson DK, Wong R, Dempsey A, Khan A, Fonseca R, Wyckoff M, Moreira A, Lasky R. Cycled Phototherapy Dose-Finding Study for Extremely Low-Birth-Weight Infants: A Randomized Clinical Trial. JAMA Pediatr. 2020 Jul 1;174(7):649-656. doi: 10.1001/jamapediatrics.2020.0559.
PMID: 32338720DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jon E Tyson, MD
The University of Texas Health Science Center, Houston
- PRINCIPAL INVESTIGATOR
David K Stevenson, MD
Stanford School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Vice Dean for Clinical Research and Healthcare Quality
Study Record Dates
First Submitted
September 12, 2013
First Posted
September 18, 2013
Study Start
March 1, 2014
Primary Completion
January 1, 2017
Study Completion
January 1, 2018
Last Updated
June 16, 2016
Record last verified: 2016-06