Assessment of Nationwide Bronchopulmonary Dysplasia in Very Preterm Infants From China (AWARD): Study Protocol for a Prospective Observational Study

Background: Bronchopulmonary dysplasia (BPD) is associated with poor outcome in preterm infants. However, no high-quality research has reported the current epidemiologic characteristics of BPD in China. NICHD developed a proposal for an updated definition for BPD in 2016 because of the limitation of the current definition. We will evaluate the epidemiology and outcome of BPD and compare the two criteria to identify the best definition predictive of short-term outcomes in Chinese preterm infants.

Methods/Design: This is a prospective observational study. We anticipate collecting data on over 3800 very preterm infants admitted to neonatal intensive care units (NICUs). Data to be collected includes admission general information, perinatal information, primary neonatal diagnosis, daily laboratory values specific for respiratory function, use of assisted ventilation and drugs specific about BPD, NICU length of stay and hospital costs. The primary outcome is to report the epidemiology and associated short-term outcomes of BPD in very preterm infants from China. Additionally, we will create prediction models for BPD by fitting maternal and neonatal characteristics, medical records information and respiratory support variables into a logistic multivariable analysis.

Discussion: The AWARD study is designed to be the largest prospective BPD study to date to elucidate the epidemiology, risk factors, outcomes and predictive tools of BPD in NICUs in China. It will provide a broad and invaluable resource for neonatologist seeking to study risk factors, prediction, identification, and treatment options for BPD, affecting a significant proportion of preterm infants.

Trial registration: ClinicalTrials.gov: NCT03850457.