Pediatric Acute Respiratory Distress Syndrome Incidence and Epidemiology (PARDIE) Study
The Pediatric Acute Respiratory Distress Syndrome Incidence and Epidemiology (PARDIE) study is designed as a multi-center international observational, cross sectional study of new cases of PARDS involving 5 continuous days of screening and patient enrollment, occurring every 2 months for a year (6 total study weeks). Included patients will have a new diagnosis of PARDS during the study week or be at risk for PARDS. Data collection will concentrate on the first 3 days of PARDS diagnosis, and follow outcomes such as mortality and length of ventilation. The main goal of PARDIE is to better understand the implications of the new Pediatric Acute Lung Injury Consensus Conference (PALICC) definition of Pediatric ARDS on the incidence and epidemiology of Pediatric ARDS.
The PARDIE study is comprised of a main study (V.0), and several ancillary or complementary studies. The ancillary studies are V.1, V.2, and V.3 which require additional data collection on patients already enrolled in V.0. These three ancillary studies do not require screening of additional patients not already included in V.0. Two complementary studies (V.4 and Cardiac PARDIE), require screening additional patients in the intensive care units, and have different inclusion and exclusion criteria. It is possible that some patients are first enrolled in V.4 (at risk for PARDS) and are subsequently enrolled in V.0. Patients enrolled in Cardiac PARDIE will not be enrolled in any of the other studies. At our site, we will not enroll patients for PARDIE V.3 or Cardiac PARDIE.
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Included patients must meet all 4 PARDS criteria below (Timing, Origin of edema, Chest imaging, Oxygenation):
Hypoxemia within 7 days of a known clinical insult (PARDS risk factor)
AND Respiratory failure not fully explained by cardiac failure or fluid overload
AND Chest imaging findings of new infiltrate(s) consistent with acute pulmonary parenchymal disease
AND Minimal hypoxemia criteria based on mechanical ventilator support
Full face (oro-nasal) mask CPAP or BiPAP (minimal CPAP 5 cmH20) with PaO2/FiO2 (PF) ratio ? 300 or SpO2/FiO2 (SF) ratio ? 264 or
Invasive mechanical ventilation with Oxygenation Index ? 4 or Oxygen Saturation Index ? 5
AND All diagnostic criteria for PARDS are met for the first time within the previous 24 hours (only new cases of PARDS)
AND For children with chronic home mechanical ventilation, they must have an acute deterioration in oxygenation from their baseline
Primary disease category: Asthma & Lung
Secondary disease categories: Children, Infants & Newborns
Projected enrollment dates: April 2016 to April 2018
Official study title: Pediatric Acute Respiratory Distress Syndrome Incidence and Epidemiology (PARDIE) Study