Cycled phototherapy for extremely premature infants
Cycled Phototherapy: A Safer Effective Method to Control the Serum Bilirubin Of Extremely Premature Infants?
This study is testing if giving breaks during light treatment can help extremely premature babies stay healthy while lowering the risks linked to constant bright light exposure.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1700 (estimated) |
| Ages | 22 Weeks to 27 Weeks |
| Sex | All |
| Sponsor | NICHD Neonatal Research Network Research network |
| Locations | 19 sites (Birmingham, Alabama and 18 other locations) |
| Trial ID | NCT03927833 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of cycled phototherapy (PT) compared to continuous PT in extremely premature infants weighing less than 750 grams or born before 27 weeks of gestation. The approach aims to minimize potential adverse effects associated with uninterrupted exposure to bright light, which may include photo-oxidative injury and reduced blood flow. By utilizing a regimen of cycled PT, the study seeks to reduce the total hours of treatment while maintaining bilirubin levels within safe limits. The trial will enroll inborn infants aged 12-36 hours who meet specific weight and gestational criteria.
Who should consider this trial
Good fit: Ideal candidates for this study are inborn infants weighing 750 grams or less at birth and/or born before 27 weeks of gestation, aged between 12 to 36 hours.
Not a fit: Patients who may not benefit include those with known hemolytic disease, major anomalies, or those who are likely to expire soon.
Why it matters
Potential benefit: If successful, this approach could improve survival rates and reduce complications for extremely premature infants undergoing treatment for hyperbilirubinemia.
How similar studies have performed: Previous studies have shown success with cycled phototherapy in reducing treatment hours and maintaining bilirubin levels, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Birmingham, Alabama and 18 other locations
- University of Alabama at Birmingham — Birmingham, Alabama, United States (Recruiting)
- Stanford University — Palo Alto, California, United States (Recruiting)
- Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States (Recruiting)
- Emory University — Atlanta, Georgia, United States (Recruiting)
- Northwestern Lurie Children's Hospital of Chicago — Chicago, Illinois, United States (Not_yet_recruiting)
- University of Iowa — Iowa City, Iowa, United States (Recruiting)
- University of Mississippi Medical Center - Children's of Mississippi — Jackson, Mississippi, United States (Not_yet_recruiting)
- University of New Mexico — Albuquerque, New Mexico, United States (Recruiting)
- University of Rochester — Rochester, New York, United States (Active_not_recruiting)
- RTI International — Durham, North Carolina, United States (Active_not_recruiting)
- Duke University — Durham, North Carolina, United States (Recruiting)
- Cincinnati Children's Medical Center — Cincinnati, Ohio, United States (Recruiting)
- Case Western Reserve University, Rainbow Babies and Children's Hospital — Cleveland, Ohio, United States (Recruiting)
- Research Institute at Nationwide Children's Hospital — Columbus, Ohio, United States (Active_not_recruiting)
- Univeristy of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Brown University - Women and Infants Hospital of Rhode Island — Providence, Rhode Island, United States (Active_not_recruiting)
- University of Texas Southwestern Medical Center at Dallas — Dallas, Texas, United States (Recruiting)
- University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
- University of Utah — Salt Lake City, Utah, United States (Recruiting)
Study contacts
- Principal investigator: Jon Tyson, MD — The University of Texas Health Science Center, Houston
- Study coordinator: Jon Tyson, MD
- Email: Jon.E.Tyson@uth.tmc.edu
- Phone: 713-500-5790
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.