Cycled Phototherapy Dose-Finding Study for Extremely Low-Birth-Weight Infants
| Autor: | Ronald J. Wong, Cody Arnold, David K. Stevenson, Robert E. Lasky, Myra H. Wyckoff, Wally Carlo, Claudia Pedroza, Jon E. Tyson, Amir M. Khan, Allison G. Dempsey, Alvaro Moreira, Rafael Fonseca |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Male
Neonatal intensive care unit Birth weight Gestational Age law.invention Randomized controlled trial law Intensive Care Units Neonatal Humans Medicine Original Investigation Retrospective Studies Hematologic Tests business.industry Infant Newborn Postmenstrual Age Infant Gestational age Bilirubin Phototherapy Interim analysis Jaundice Neonatal Low birth weight Infant Extremely Low Birth Weight Relative risk Anesthesia Pediatrics Perinatology and Child Health Female medicine.symptom business Biomarkers Follow-Up Studies |
| Zdroj: | JAMA Pediatr |
| ISSN: | 2168-6203 |
| Popis: | Importance Cycled (intermittent) phototherapy (PT) might adequately control peak total serum bilirubin (TSB) level and avoid mortality associated with usual care (continuous PT) among extremely low-birth-weight (ELBW) infants (401-1000 g). Objective To identify a cycled PT regimen that substantially reduces PT exposure, with an increase in mean peak TSB level lower than 1.5 mg/dL in ELBW infants. Design, Setting, and Participants This dose-finding randomized clinical trial of cycled PT vs continuous PT among 305 ELBW infants in 6 US newborn intensive care units was conducted from March 12, 2014, to November 14, 2018. Interventions Two cycled PT regimens (≥15 min/h and ≥30 min/h) were provided using a simple, commercially available timer to titrate PT minutes per hour against TSB level. The comparator arm was usual care (continuous PT). Main Outcomes and Measures Mean peak TSB level and total PT hours through day 14 in all 6 centers and predischarge brainstem auditory-evoked response wave V latency in 1 center. Mortality and major morbidities were secondary outcomes despite limited power. Results Consent was requested for 452 eligible infants and obtained for 305 (all enrolled) (mean [SD] birth weight, 749 [152] g; gestational age, 25.7 [1.9] weeks; 81 infants [27%] were multiple births; 137 infants [45%] were male; 112 [37%] were black infants; and 107 [35%] were Hispanic infants). Clinical and demographic characteristics of the groups were similar at baseline. After a preplanned interim analysis of 100 infants, the regimen of 30 min/h or more was discontinued, and the study proceeded with 2 arms. Comparing 128 infants receiving PT of 15 min/h or more with 128 infants receiving continuous PT among those surviving to 14 days, mean peak TSB levels were 7.1 vs 6.4 mg/dL (adjusted difference, 0.7; 95% CI, 0.4-1.1 mg/dL) and mean total PT hours were 34 vs 72 (adjusted difference, −39; 95% CI, −45 to −32). Wave V latency adjusted for postmenstrual age was similar in 37 infants receiving 15 min/h or more of PT and 33 infants receiving continuous PT: 7.42 vs 7.32 milliseconds (difference, 0.10; 95% CI, −0.11 to 0.30 millisecond). The relative risk for death was 0.79 (95% CI, 0.40-1.54), with a risk difference of −4.5% (95% CI, −10.9 to 2.0). Morbidities did not differ between groups. Conclusions and Relevance Cycled PT can substantially reduce total PT with little increase in peak TSB level. A large, randomized trial is needed to assess whether cycled PT would increase survival and survival without impairment in small, preterm infants. Trial Registration ClinicalTrials.gov Identifier:NCT01944696 |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|