(10) Hydrocortisone Use in Infants Born at the Limits of Viability

Ashley C. Wethall, Nationwide Children's Hospital, United States; Brian K. Rivera, The Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, United States; Angelo Naples, The Abigail Wexner Research Institute at Nationwide Children's Hospital, United States; Waceys Jama, The Abigail Wexner Research Institute at Nationwide Children's Hospital, United States; Leeann Pavlek, Nationwide Children's Hospital, United States; Carl Backes, Nationwide Children's Hospital, United States

Background: Evidence on potential benefits of postnatal hydrocortisone (HCTZ) among preterm infants has led to growing use among health care providers. Previous studies have largely excluded infants born at the limits of viability (22-23 weeks of gestation), which has left this subgroup of infants in an area of “therapeutic uncertainty” regarding postnatal HCTZ.

Objectives: We describe postnatal HCTZ use (frequency, duration, dosing, major adverse events), and evaluate determinants of use among infants born at the limits of viability.

Design/Methods: Retrospective study at a single, large pediatric tertiary care center (1/1/2010 – 12/31/2020). Data extraction and assignment of primary indications for HCTZ use were independently performed by multiple investigators. Outcomes were agreed on a priori. Major adverse events attributed to HCTZ were defined as spontaneous gastrointestinal perforation, culture-proven sepsis, or hyperglycemia resulting in insulin treatment. For proportionate comparisons, Fisher’s exact test or chi-squared tests were used. Continuous variables were compared using the Mann-Whitney test. All tests used a significance level of p< 0.05.

Results: Among 96 infants born at the limits of viability, most (N=61, 63.5%) received postnatal HCTZ. Median postnatal day at initiation was 9 (IQR: 9-23); duration of HCTZ use was 49 days (IQR: 13–78). Median initial dosing regimen was 1 mg/kg/day (range 0.5-2.0 mg/kg/day). We identified 5 (8%) infants with a major adverse event; all were hyperglycemia requiring insulin treatment. Primary indications for HCTZ use were adrenal insufficiency in the setting of an emergent procedure (N=49, 41.9%), adrenal insufficiency not related to procedure (N=30, 25.6%), hypotension (N=34, 29.1%), or other (N=4, 3.4%; e.g., BPD prophylaxis). We observed no difference in postnatal HCTZ use among infants born at 22 versus 23 weeks of gestation (61.9% vs 64.8%, P=0.53). Interestingly, 50.8% (N=31) received additional exposure to HCTZ during their initial hospitalizations.

Conclusion: Despite a lack of robust evidence, we observed that most infants born at the limits of viability are exposed to at least one course of HCTZ therapy and do not undergo ACTH stimulation test. In view of contemporary practice patterns, the critical need for inclusion of infants born at the limits of viability in clinical trials on postnatal HCTZ use is acknowledged.