P0725 - Early Prophylactic Hydrocortisone to Improve Outcomes in Extremely Preterm Infants: A Quality Improvement Project.

Background: Optimal nutrition and early extubation are important interventions to reduce the risk of Bronchopulmonary Dysplasia (BPD). A randomized controlled trial (PREMILOC) suggested that the use of early, prophylactic hydrocortisone (HCN) improves survival without BPD.

Objective: To compare the rates of survival and BPD before and after the implementation of an early low dose HCN treatment protocol in infants less than 29 weeks gestational age (GA). Protocol compliance and adverse events were also assessed.

Methodology: We undertook a retrospective cohort study of infants 22 0/7 - 28 6/7 weeks GA born at Lucile Packard Children’s Hospital at Stanford from 7/1/2017 to 12/1/2019. Following implementation of the PREMILOC protocol, qualifying infants received HCN at 0.5 mg/kg q 12 for 7 days followed by 0.5 mg/kg q 24 for 3 days; exclusions were based on the published RCT. Primary outcomes were: 1) survival, and 2) BPD, defined as need for supplemental oxygen at 36 weeks post menstrual age. Secondary outcomes included protocol compliance, reasons for discontinuation, necrotizing enterocolitis (NEC) and spontaneous intestinal perforation (SIP).

Discussion: A total of 133 infants were included in the study of which 77 infants were not treated with the PREMILOC HCN protocol. Of the 56 infants that were treated with the PREMILOC HCN protocol, 26 infants deviated from protocol: 9 due to hyperglycemia, 3 due to hypertension, 1 due to SIP and 13 for other/unknown reasons. The non-treatment and treatment groups had similar survival (84% in non-exposed vs. 89% in the exposed, p = 0.58) as well as similar rates of BPD (47% in non-exposed vs. 38% in exposed, p = 0.38). Following PREMILOC HCN exposure, a significant increase in the NEC rate was noticed [2.5% in non-exposed vs. 16% in exposed [aOR 3.26 (1.19 – 2.73), p = 0.006)]. SIP rates were similar between the two groups.

Conclusions: Implementation of the PREMILOC protocol did not improve survival nor did it reduce BPD. Significant complications associated with hydrocortisone such as hyperglycemia, hypertension, and NEC, resulted in pausing of this protocol for further review.