Hydrocortisone to Improve Survival without Bronchopulmonary Dysplasia.

BACKGROUND: Bronchopulmonary dysplasia is a prevalent complication after extremely preterm birth. Inflammation with mechanical ventilation may contribute to its development. Whether hydrocortisone treatment after the second postnatal week can improve survival without bronchopulmonary dysplasia and without adverse neurodevelopmental effects is unknown. METHODS: We conducted a trial involving infants who had a gestational age of less than 30 weeks and who had been intubated for at least 7 days at 14 to 28 days. Infants were randomly assigned to receive either hydrocortisone (4 mg per kilogram of body weight per day tapered over a period of 10 days) or placebo. Mandatory extubation thresholds were specified. The primary efficacy outcome was survival without moderate or severe bronchopulmonary dysplasia at 36 weeks of postmenstrual age, and the primary safety outcome was survival without moderate or severe neurodevelopmental impairment at 22 to 26 months of corrected age. RESULTS: We enrolled 800 infants (mean [±SD] birth weight, 715±167 g; mean gestational age, 24.9±1.5 weeks). Survival without moderate or severe bronchopulmonary dysplasia at 36 weeks occurred in 66 of 398 infants (16.6%) in the hydrocortisone group and in 53 of 402 (13.2%) in the placebo group (adjusted rate ratio, 1.27; 95% confidence interval [CI], 0.93 to 1.74). Two-year outcomes were known for 91.0% of the infants. Survival without moderate or severe neurodevelopmental impairment occurred in 132 of 358 infants (36.9%) in the hydrocortisone group and in 134 of 359 (37.3%) in the placebo group (adjusted rate ratio, 0.98; 95% CI, 0.81 to 1.18). Hypertension that was treated with medication occurred more frequently with hydrocortisone than with placebo (4.3% vs. 1.0%). Other adverse events were similar in the two groups. CONCLUSIONS: In this trial involving preterm infants, hydrocortisone treatment starting on postnatal day 14 to 28 did not result in substantially higher survival without moderate or severe bronchopulmonary dysplasia than placebo. Survival without moderate or severe neurodevelopmental impairment did not differ substantially between the two groups. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01353313.).

Development and Validation of Simulation-Based Procedural Checklists for Evaluation of Neonatal Nurse Practitioner Performance.

BACKGROUND: Neonatal nurse practitioner (NNP) procedural competence is essential. Procedural simulation provides opportunity to practice high-risk, low-frequency procedures and helps improve skill retention. A formal procedural simulation experience was created in an attempt to provide sufficient experience for NNPs. While preparing for the simulation experience, the group recognized the lack of validated competency metrics for most neonatal intensive care unit (NICU) procedures. PURPOSE: The purpose of this study was to create and validate procedural checklists measuring competence of NNPs participating in simulated performance of 9 high-risk NICU procedures. METHODS: IRB approval was obtained and NNPs agreed to data collection. A self and peer assessment tool was developed and distributed to NNPs, nurses, and neonatologists to gather a baseline perception of procedural competency. Procedural checklists were then developed to measure/assess individual skills against a standard. Benchmark videos were created to demonstrate the standard approach to procedural performance. Each procedural skill performed by the NNP participant was scored by 3 individual evaluators: once in real time and twice by video recording analysis. FINDINGS/RESULTS: A Cronbach α was used to measure the reliability and validity of the procedural checklists. Comparison was made between live grading and video-based grading scores using analysis of variance. Difference between grading modalities was less than 3% and nonsignificant for 8 of 9 procedures. No significant difference was found between individual graders for any of the skills being evaluated and suggested high interrater reliability of the checklists. IMPLICATIONS FOR PRACTICE: Objective, standardized procedural checklists are valid tools to evaluate NNP procedural skills in simulation. Procedural simulation experiences help strengthen skills, improve performance, and possibly improve patient outcomes.