WIP 22 - The Use of Sedatives and Paralytics in the Management of Infants with Persistent Pulmonary Hypertension of the Newborn

Publication Number: WIP 22.7592

Emmanuelle Lavassani, Duke University School of Medicine, Durham, NC, United States; Lakshmi Katakam, Duke, Durham, NC, United States; Veeral Tolia, Pediatrix, dallas, TX, United States; Rachel G. Greenberg, Duke Clinical Research Institute, Durham, NC, United States; Samia Aleem, Duke University, Durham, NC, United States

Background: Use of sedatives and paralytics in the management of infants with persistent pulmonary hypertension of the newborn (PPHN) has not been well described in literature. Pulmonary vasodilators are the mainstay of PPHN treatment, however, a low stimulation environment with adequate sedation is also a component of optimal management. It is known that sedation agents are commonly used in the neonatal intensive care unit (NICU), yet the current use of sedatives in PPHN management needs further characterization.

Objective: Describe the use of sedative and paralytic agents in infants with PPHN, characterize medication selection and administration, and examine changes in prescribing practices over time.

Design/Methods: We will conduct a cohort study using deidentified data from the Pediatrix Medical Group Clinical Data Warehouse of infants in >350 NICUs. We will include inborn infants who were born at > 34 weeks gestational age, received inhaled nitric oxide within 7 days of age, and were discharged from or died in a Pediatrix NICU between 2010 and 2022.
Infants will be stratified by type(s) of agents administered, including benzodiazepines, opioids, paralytics, barbiturates, dexmedetomidine, and other agents (ketamine, clonidine, and propofol). We will use summary statistics to describe administration of sedative and paralytic agents. We will evaluate frequency of medication use, day of initiation, duration of exposure, type of ventilator, use of ECMO, death within the first 7 postnatal days, and death prior to discharge.
Frequencies and percentages will be used for categorical variables, and medians (with interquartile ranges) will be used for continuous variables. We will use Kruskal-Wallis or Chi-squared test to compare demographics and clinical characteristics between the groups. The study has been approved by the Institutional Review Board. Data will be analyzed by December 2024.