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Effect of Prophylaxis for Early Adrenal Insufficiency Using Low-Dose Hydrocortisone in Very Preterm Infants: An
Michele L Shaffer1, Olivier Baud2, Thierry Lacaze-Masmonteil3
1Department of Statistics, University of Washington, Seattle, WA.
Insights
Early low-dose hydrocortisone prophylaxis improves survival without bronchopulmonary dysplasia (BPD) in very preterm infants. This therapy also reduces the need for medical treatment for patent ductus arteriosus and lowers mortality before discharge.
Area of Science:
- Neonatalogy
- Pediatric Critical Care
- Pharmacology
Background:
- Bronchopulmonary dysplasia (BPD) is a significant complication in very preterm infants.
- Early adrenal insufficiency is a concern in this vulnerable population.
- The prophylactic use of low-dose hydrocortisone is being investigated to improve outcomes.
Purpose of the Study:
- To evaluate the effect of low-dose hydrocortisone prophylaxis on survival without BPD in very preterm infants.
- To conduct an individual patient data meta-analysis of randomized controlled trials.
Main Methods:
- An individual patient data meta-analysis was performed on data from eligible randomized controlled trials.
- The primary outcome was survival without BPD at 36 weeks of postmenstrual age.
- Secondary outcomes included medical treatment for patent ductus arteriosus, death before discharge, gastrointestinal perforation, and late-onset sepsis.
Main Results:
- Low-dose hydrocortisone significantly increased survival without BPD (OR, 1.45; P=.007).
- The therapy decreased medical treatment for patent ductus arteriosus (OR, 0.72; P=.01) and death before discharge (OR, 0.70; P=.03).
- An increased risk of gastrointestinal perforation was observed when hydrocortisone was combined with indomethacin, and late-onset sepsis incidence rose (OR, 1.34; P=.04).
Conclusions:
- Early low-dose hydrocortisone therapy is beneficial for improving survival without BPD in very preterm infants.
- While associated with some risks, the benefits for survival outweigh the adverse effects.
- Further research may be warranted to optimize its use and mitigate potential risks.
Objective:
To assess the effect of prophylaxis for early adrenal insufficiency using low-dose hydrocortisone on survival without bronchopulmonary dysplasia (BPD) in very preterm infants using an individual patient data meta-analysis.
Study Design:
All existing randomized controlled trials testing the efficacy of the prophylaxis of early adrenal insufficiency using low-dose hydrocortisone on survival without BPD were considered for inclusion when data were available. The primary outcome was the binary variable survival without BPD at 36 weeks of postmenstrual age.
Results:
Among 5 eligible studies, 4 randomized controlled trials had individual patient data available (96% of participants identified; n = 982). Early low-dose hydrocortisone treatment for 10-15 days was associated with a significant increase in survival without BPD (OR, 1.45; 95% CI, 1.11-1.90; P = .007; I2 = 0%), as well as with decreases in medical treatment for patent ductus arteriosus (OR, 0.72; 95% CI, 0.56-0.93; P = .01; I2 = 0%) and death before discharge (OR, 0.70; 95% CI, 0.51-0.97; P = .03; I2 = 0%). The therapy was associated with an increased risk of spontaneous gastrointestinal perforation (OR, 2.50; 95% CI, 1.33-4.69; P = .004; I2 = 31.9%) when hydrocortisone was given in association with indomethacin exposure. The incidence of late-onset sepsis was increased in infants exposed to hydrocortisone (OR, 1.34; 95% CI, 1.02-1.75; P = .04; I2 = 0%), but no adverse effects were reported for either death or 2-year neurodevelopmental outcomes as assessed in an aggregate meta-analysis.
Conclusions:
This individual patient data meta-analysis showed that early low-dose hydrocortisone therapy is beneficial for survival without BPD in very preterm infants.
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