Grant: Project Grant

Background: Over 60% of extremely low gestational age neonates (ELGANs, defined as gestational age < 28 weeks) suffer from patent ductus arteriosus (PDA) and they are the neonates at highest risk for mortality and severe morbidity, including life-limiting neurodevelopmental impairments. PDA management is highly controversial, mostly due to a lack of improvement in neonatal outcomes reported in clinical trials of treatment, though studies have failed to properly define which PDAs are 'hemodynamically significant' through validation against major clinical outcomes. Objective: The objective of this study is to define 'significant PDA' by comprehensively examining clinical and echocardiography characteristics early in the disease process and developing prediction models for mortality and severe neonatal morbidity in a large, prospective, multicentre, national cohort of ELGANs. Setting and Methods: This study will be a collaboration of the Canadian Neonatal Network (CNN, a comprehensive neonatal database) and the Canadian Targeted Neonatal Echocardiography Collaborative (a collaborative of neonatologists with expertise in echocardiography and hemodynamics, representing nearly all institutions in Canada which care for ELGANs). Together the already comprehensive clinical data in CNN will be augmented with clinical and echocardiography parameters of PDA evaluation and treatment. Models will be derived for four postnatal-age specific periods after birth (Day 1-3, Day 4-7, Day 8-14, and Day 15-28) using evaluations conducted during the respective time periods. Partial least square discriminate analysis will be used to derive the prediction models and all models will undergo internal and external validation. Impact: This study will provide valuable information for clinicians by identifying which infants with PDA are at risk for mortality and severe morbidity and by defining and validating patient inclusion criteria for future trials of PDA treatment.