- ClinicalTrials.gov ID: NCT01944696
- Not accepting healthy volunteers
- UTSW Principal Investigator: MYRA H WYCKOFF
summary
This is a pragmatic, minimal risk, randomized, clinical trial addressing patient safety and to provide the data needed to change clinical practice if appropriate in accordance with the tenets to 1)first do no harm and to 2) use the lowest effective dose of a therapy to reduce the risk of known or unknown treatment hazards. infants [Less Than]/[?] 750 grams birthweight or [Less Than]27 weeks will be randomized to either agressive phototherapy (continuous photherapy-usual standard of care in most niCus) or cycled phototherapy (15minutes/hour regime.) Hypotheses 1. The [Greater Than]15 min/h cycled phototherapy regimen will control the peak Total Serum Bilirubin (mean [Less Than]8.0 mg/dL)* and reduce total phototherapy hours by [Greater Than]60% in 1st 4 days and [Greater Than]40% in 1st 14 days. 2. Cycled phototherapy is likely to increase survival over that with continuous phototherapy. as estimated in conservative Bayesian analyses (using a neutral prior probability), the (posterior) probability will be [Greater Than]70% that cycled PT increases survival to discharge (1[Degrees]outcome).* 3) Cycled phototherapy will not substantially increase (as indicated by a RR [Less Than]1.10) death or major neonatal morbidity: (severe iCH, PVL, BPD, late onset sepsis, [Greater Than] grade 3 RoP).
objective
The primary outcome of this study is to increase survival to discharge. With secondary outcomes to decrease the mean total hours of phototherapy, the mean peak total serum bilirubin and major neonatal morbidity (severe intracranial hemorrahage, ventricular enlargement of cystic white matter disease, bronchopulmonary dysplasia, late onset sepsis, necrotizing entercolitis or spontaneous intestinal perforation, or [Greater Than]/[?] grade 3 retrolental fibroplasia, patent ductus arteriosus treated with surgery or nSaiDS. Post discharge objectives are a decrease in neurodevelopmental impairment or death.