ACTIVE_NOT_RECRUITING

Cycled Phototherapy

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Conditions

Hyper BilirubinemiaPremature InfantInfant, Newborn, DiseasesPhototherapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Cycled phototherapy (PT) is likely to increase survival over that with continuous PT among extremely premature infants (\< 750 g BW or \<27 weeks GA).

Official Title

Cycled Phototherapy: A Safer Effective Method to Control the Serum Bilirubin Of Extremely Premature Infants?

Quick Facts

Study Start:2020-07-16
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03927833

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

Contacts and Locations

Principal Investigator

Jon Tyson, MD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: NICHD Neonatal Research Network

  • Jon Tyson, MD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-16
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2020-07-16
Study Completion Date2025-07-31

Terms related to this study

Keywords Provided by Researchers

  • Infant, Newborn, Diseases
  • Phototherapy

Additional Relevant MeSH Terms

  • Hyper Bilirubinemia
  • Premature Infant