Clinical Trials in Mexico / NCT03927833
Active, not recruiting
Not applicable
Cycled Phototherapy
NCT03927833 · tracked via the Priya Life Science Mexico tracker
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
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)
| Facility | City | Region | Status |
|---|---|---|---|
| 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 |
More NICHD Neonatal Research Network trials in Mexico
Follow-up Visit of High Risk Infants
Recruiting
The Budesonide in Babies (BiB) Trial
Active, not recruiting
Other trials for the same condition
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