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Early Prophylactic Hydrocortisone and Bronchopulmonary Dysplasia-Free Survival in Extremely Preterm Infants
Veronica Smedbäck1,2, Lars J Björklund3,4, Anders Flisberg5,6
1Department of Biomedical and Clinical Sciences, Division of Children's and Women's health, Linköping University, Linköping, Sweden.
Insights
Early prophylactic hydrocortisone in extremely preterm infants improved survival without bronchopulmonary dysplasia (BPD). This large-scale study found increased survival rates with no significant rise in severe neonatal morbidities, supporting its clinical use.
Area of Science:
- Neonatal Medicine
- Pediatric Critical Care
- Pharmacology in Neonates
Background:
- Randomized trials suggest early prophylactic hydrocortisone benefits extremely preterm infants, improving survival without bronchopulmonary dysplasia (BPD) with minimal adverse effects.
- Large-scale implementation data are crucial for evaluating the clinical effects and safety of this intervention.
Purpose of the Study:
- To assess the association between early prophylactic hydrocortisone and survival without BPD at 36 weeks' postmenstrual age (PMA) in extremely preterm infants in Sweden.
- To evaluate the safety profile of prophylactic hydrocortisone in this vulnerable population following guideline implementation.
Main Methods:
- A national historical cohort study utilizing prospectively collected data from the Swedish Neonatal Quality register.
- Inclusion of infants born between 22 and 27 weeks' gestation (2018-2023), comparing those who received hydrocortisone prophylaxis (exposed) with those who did not (nonexposed) based on intention-to-treat.
- Primary outcome: survival without BPD at 36 weeks' PMA, analyzed using logistic regression to calculate adjusted odds ratios.
Main Results:
- The study included 1106 infants; 474 received hydrocortisone. Survival without BPD was higher in the exposed group (32.5%) compared to the nonexposed group (29.3%) (adjusted odds ratio, 1.62).
- Bronchopulmonary dysplasia (BPD) rates were lower in the exposed group (49.2%) versus nonexposed (54.6%) (adjusted odds ratio, 0.65).
- While late-onset bacterial infection was more frequent in exposed infants before adjustment, no other significant differences in severe neonatal morbidities were observed between groups.
Conclusions:
- The implementation of prophylactic hydrocortisone in extremely preterm infants was associated with improved survival without BPD.
- The study found no significant increase in severe neonatal morbidities, suggesting a favorable safety profile for this intervention in large-scale clinical practice.
Importance:
In randomized trials, early prophylactic hydrocortisone improved survival without bronchopulmonary dysplasia (BPD) with few adverse effects in extremely preterm infants. Large scale implementation data are needed to evaluate clinical effects and safety.
Objective:
To examine the association between early prophylactic hydrocortisone and survival without BPD at 36 weeks' postmenstrual age (PMA) in extremely preterm infants in Sweden after guideline implementation and to assess treatment safety.
Design, Setting, And Participants:
A national historical cohort study with prospectively collected data from the Swedish Neonatal Quality register from 4 Swedish centers where hydrocortisone prophylaxis was implemented. The study included infants born between 22 and 27 weeks' gestation between 2018 and 2023. Infants were divided into exposed and nonexposed groups according to the intention-to-treat principle.
Exposure:
Hydrocortisone, 1 mg/kg/d, for the first 7 days of life, followed by 0.5 mg/kg/d from days 8 through 10.
Main Outcomes And Measures:
The primary outcome was survival without BPD at 36 weeks' PMA. A predefined statistical analysis plan with logistic regression was used to calculate unadjusted and adjusted odds ratios.
Results:
Among 1106 infants (median [IQR] gestational age, 25 weeks, 6 days [24 weeks, 3 days to 27 weeks]; median [IQR] birth weight, 780 [610-964] g), 474 received hydrocortisone prophylaxis and 632 did not. Survival without BPD occurred in 154 of 474 exposed (32.5%) and 185 of 632 nonexposed (29.3%) infants (adjusted odds ratio, 1.62; 95% CI, 1.16-2.27). BPD occurred in 233 exposed (49.2%) and 345 nonexposed (54.6%) infants (adjusted odds ratio, 0.65; 95% CI, 0.49-0.86). Death before 36 weeks' PMA occurred in 87 exposed (18.4%) and 102 nonexposed (16.1%) infants. Late-onset bacterial infection was more common in exposed infants, but not significant after adjustment. No other severe neonatal morbidities differed significantly between the 2 groups.
Conclusions And Relevance:
In this cohort study of extremely preterm infants, the introduction of prophylactic hydrocortisone was associated with increased survival without BPD, after adjusting for covariates. There was no significant increase in severe neonatal morbidities, except that late-onset bacterial infection was more common in the exposed group before adjustments.
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