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Cycled Phototherapy Dose-Finding Study for Extremely Low-Birth-Weight Infants: A Randomized Clinical Trial
Cody Arnold1, Jon E Tyson1, Claudia Pedroza1
1McGovern Medical School, University of Texas, Houston.
Insights
Cycled phototherapy (PT) significantly reduces treatment time for extremely low-birth-weight infants with minimal increase in bilirubin levels. Further research is needed to confirm if this method improves survival rates.
Area of Science:
- Neonatal care
- Pediatric intensive care
- Bilirubin metabolism
Background:
- Jaundice is common in extremely low-birth-weight (ELBW) infants.
- Continuous phototherapy (PT) is standard but associated with mortality risks.
- Intermittent or cycled PT may offer a safer alternative.
Purpose of the Study:
- To find a cycled PT regimen for ELBW infants.
- Reduce PT exposure while limiting peak total serum bilirubin (TSB) increase.
- Assess safety and efficacy compared to continuous PT.
Main Methods:
- Dose-finding randomized clinical trial involving 305 ELBW infants.
- Compared two cycled PT regimens (15 min/h and 30 min/h) against continuous PT.
- Measured peak TSB levels, total PT hours, and auditory brainstem responses.
Main Results:
- Cycled PT (15 min/h) reduced total PT hours by approximately 50% (34 vs 72 hours).
- Mean peak TSB levels showed a small, non-significant increase (7.1 vs 6.4 mg/dL).
- No significant differences in mortality or major morbidities were observed.
Conclusions:
- Cycled PT is effective in reducing treatment duration for ELBW infants.
- Minimal increase in peak TSB suggests safety.
- Larger trials are necessary to confirm survival benefits and long-term outcomes.
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.
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