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Does aggressive phototherapy increase mortality while decreasing profound impairment among the smallest and sickest
Insights
Aggressive phototherapy (AgPT) may increase mortality in the smallest, sickest infants, despite reducing impairment. New methods are needed to safely lower bilirubin levels in extremely low-birth-weight (ELBW) infants.
Area of Science:
- Neonatal Medicine
- Pediatric Critical Care
- Neonatal Intensive Care
Background:
- Aggressive phototherapy (AgPT) is a common treatment for hyperbilirubinemia in newborns.
- Its safety and efficacy in the most vulnerable infants, including extremely low-birth-weight (ELBW) infants, require further investigation.
Purpose of the Study:
- To evaluate the benefits and harms of AgPT in ELBW infants (≤ 1000g).
- To compare outcomes between the smallest/sickest ELBW infants (≤ 750g) and other ELBW infants.
Main Methods:
- A randomized trial involving 1974 ELBW infants comparing AgPT to conservative phototherapy.
- Outcomes assessed at 18-22 months corrected age, analyzed by birth weight stratum and illness severity.
- Bayesian analyses were used to assess the probability of benefit and harm.
Main Results:
- Among mechanically ventilated infants ≤ 750g BW, AgPT was associated with increased mortality.
- This increase in mortality offset the observed reductions in impairment and profound impairment.
- Bayesian analysis indicated a 99% probability of increased mortality with AgPT in this subgroup.
Conclusions:
- AgPT may increase mortality in the smallest and sickest ELBW infants.
- While AgPT may reduce impairment, the increased mortality risk necessitates caution.
- Development of novel, safer methods for bilirubin reduction in vulnerable neonates is crucial.
Objective:
Aggressive phototherapy (AgPT) is widely used and assumed to be safe and effective for even the most immature infants. We assessed whether the benefits and hazards for the smallest and sickest infants differed from those for other extremely low-birth-weight (ELBW; ≤ 1000 g) infants in our Neonatal Research Network trial, the only large trial of AgPT.
Study Design:
ELBW infants (n=1974) were randomized to AgPT or conservative phototherapy at age 12 to 36 h. The effect of AgPT on outcomes (death, impairment, profound impairment, death or impairment (primary outcome), and death or profound impairment) at 18 to 22 months of corrected age was related to BW stratum (501 to 750 g; 751 to 1000 g) and baseline severity of illness using multilevel regression equations. The probability of benefit and of harm was directly assessed with Bayesian analyses.
Result:
Baseline illness severity was well characterized using mechanical ventilation and FiO(2) at 24 h age. Among mechanically ventilated infants ≤ 750 g BW (n=684), a reduction in impairment and in profound impairment was offset by higher mortality (P for interaction <0.05) with no significant effect on composite outcomes. Conservative Bayesian analyses of this subgroup identified a 99% (posterior) probability that AgPT increased mortality, a 97% probability that AgPT reduced impairment, and a 99% probability that AgPT reduced profound impairment.
Conclusion:
Findings from the only large trial of AgPT suggest that AgPT may increase mortality while reducing impairment and profound impairment among the smallest and sickest infants. New approaches to reduce their serum bilirubin need development and rigorous testing.
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