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Phototherapy in ELBW newborns: does it work? Is it safe? The evidence from randomized clinical trials
Cody Arnold1, Claudia Pedroza1, Jon E Tyson1
1Department of Pediatrics, Center for Clinical Research & Evidence-Based Medicine, University of Texas Health Science Center at Houston Medical School, Houston, TX.
Insights
Phototherapy for extremely low-birth-weight infants shows mixed results. While it lowers bilirubin and reduces impairment, it may increase mortality risk in the smallest infants.
Area of Science:
- Neonatal Medicine
- Pediatric Phototherapy Research
- Infant Health Outcomes
Background:
- Phototherapy is a common treatment for jaundice in newborns.
- Its safety and efficacy in extremely low-birth-weight (ELBW) infants require critical evaluation.
- Previous trials have yielded conflicting evidence regarding neurodevelopmental outcomes.
Purpose of the Study:
- To critically assess evidence from randomized trials on phototherapy for ELBW infants.
- To evaluate the risk-benefit ratio of phototherapy in this vulnerable population.
- To identify potential strategies for optimizing phototherapy's safety and effectiveness.
Main Methods:
- Systematic review and critical appraisal of randomized controlled trials.
- Analysis of data from the Collaborative Phototherapy Trial and the Neonatal Network Trial.
- Bayesian statistical analysis of subgroup data from the Neonatal Network Trial.
Main Results:
- Phototherapy reduced serum bilirubin levels in both trials.
- Aggressive phototherapy significantly reduced profound impairment in ELBW infants.
- Both trials indicated a potential increased risk of death associated with phototherapy in the smallest infants.
Conclusions:
- Phototherapy's benefits in reducing impairment must be weighed against the increased mortality risk in ELBW infants.
- Conservative Bayesian analyses suggest a high probability of increased deaths with aggressive phototherapy in infants under 751g.
- Further research is needed to optimize phototherapy strategies, such as using lowered irradiance or light-emitting diodes, to improve the risk/benefit ratio.
Abstract:
Phototherapy is assumed to be both effective and safe for extremely low-birth-weight infants. Our objective was to critically assess the relevant evidence from randomized trials. In the decades-old Collaborative Phototherapy Trial, phototherapy reduced serum bilirubin but not neurodevelopmental impairments. In the recent and larger Neonatal Network Trial, aggressive phototherapy compared to conservative phototherapy reduced both peak serum bilirubin (7.0 vs. 9.8mg/dL) and profound impairment at 18-22 months adjusted age (relative risk = 0.68). However, both trials suggested that phototherapy increased deaths among the smallest infants. Conservative Bayesian analyses of ventilator-treated infants under 751g birth weight in the Network trial identified a 99% probability of increased deaths and 99% probability of reduced profound impairment with aggressive phototherapy. Potential strategies to optimize the risk/benefit ratio in achieving low serum bilirubin levels, e.g., use of lowered irradiance levels, light-emitting diode phototherapy units, cycled phototherapy, and/or porphyrin compounds, deserve rigorous evaluation.
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