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Active, not recruiting Not applicable

Cycled Phototherapy

NCT03927833 · tracked via the Priya Life Science Mexico tracker
Phase
Not applicable
Started
2020-07-16
Last updated
2026-06-17

Condition(s) studied

Hyper BilirubinemiaPremature Infant

Investigational drug(s) / intervention(s)

Phototherapy lights

Phototherapy lights: Phototherapy lights used continuously or timed, following an algorithm based upon TSB levels.

Study 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).

Eligibility

Sex
ALL
Min age
22 Weeks
Max age
27 Weeks
Healthy volunteers
No
Inclusion Criteria: 1. Infants is inborn 2. Infant is ≤ 750 grams at birth and/or \< 27 weeks gestation at birth by best OB estimate 3. Infant is 12-36 hours of age. Exclusion Criteria: 1. Unable to enroll infant by 36 hours of age 2. Previous phototherapy 3. Known hemolytic disease 4. TSB reported as \>6.0 mg/dL before 12 hours age 5. Major anomaly 6. Overt nonbacterial infection 7. 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.

Primary outcome measure(s)

  • Number of participants survival to discharge — Birth to hospital discharge, up to 120 days of life
    Number of Participants discharged from hospital alive, after birth.

Trial sites (19)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama
Stanford University Palo Alto California
Sharp Mary Birch Hospital for Women & Newborns San Diego California
Emory University Atlanta Georgia
Northwestern Lurie Children's Hospital of Chicago Chicago Illinois
University of Iowa Iowa City Iowa
University of Mississippi Medical Center - Children's of Mississippi Jackson Mississippi
University of New Mexico Albuquerque New Mexico
University of Rochester Rochester New York
RTI International Durham North Carolina
Duke University Durham North Carolina
Cincinnati Children's Medical Center Cincinnati Ohio
Case Western Reserve University, Rainbow Babies and Children's Hospital Cleveland Ohio
Research Institute at Nationwide Children's Hospital Columbus Ohio
Univeristy of Pennsylvania Philadelphia Pennsylvania
Brown University - Women and Infants Hospital of Rhode Island Providence Rhode Island
University of Texas Southwestern Medical Center at Dallas Dallas Texas
University of Texas Health Science Center at Houston Houston Texas
University of Utah Salt Lake City Utah
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03927833 on ClinicalTrials.gov ↗ ← All trials in Mexico