Fellow Joseph M. Sanzari Children's Hospital Hackensack University Medical Center south bellmore , New York, United States
Background: Approximately 4-10 % of term infants will develop respiratory distress after birth. Current NRP guidelines indicate continuous positive airway pressure (CPAP) for labored breathing or persistent cyanosis. Rapid changes in compliance after delivery may place neonates at risk for complications such as pneumothorax (PTX). Prospective data on the use of delivery room (DR) CPAP in term infants is scarce. Objective: Primary:To determine if full term infants with mild respiratory distress (RD) in the DR can successfully transition without the use of CPAP as compared to the standard of care (SOC). Secondary: To compare the incidence of PTX in neonates with and without exposure to DR CPAP. Design/Methods: This is an IRB approved, single center randomized prospective pilot study. Eligibility criteria: term neonates born via scheduled c-section without labor who present with mild RD defined as nasal flaring, intermittent grunting, mild retractions and/or tachypnea. Exclusion criteria: moderate/severe RD, major congenital anomalies, chromosomal abnormalities or meconium stained fluid. After consent is obtained, infants are randomized 2:1 intervention to SOC. Infants randomized to the intervention group will be observed by direct supervision for the first 20 minutes of life in room air in the DR. If moderate/severe RD develops at any point or mild RD continues after 20 min, DR CPAP will be applied. Infants in the SOC group will have CPAP applied. Newborns with resolution of RD will be admitted to the well nursery and be monitored for three hours with direct nursing observation and continuous pulse oximetry. A chest ultrasound will be performed by 6 hours of life to assess for PTX in all study subjects. Enrollment is in process. Based on institutional data, it is anticipated that 60 infants/year will be eligible. We anticipate obtaining consent in 60%, resulting in 35 study subjects. Descriptive statistics will be used to summarize the data and group comparisons will be explored using ANOVA or Pearson’s chi-squared test with a p value of 0.05 followed by pairwise tests, if needed.
