Paediatric ARDS Incidence and Epidemiology(PARDIE) study
Research type
Research Study
Full title
The Paediatric Acute Respiratory Distress Syndrome Incidence and Epidemiology (PARDIE) study
IRAS ID
203014
Contact name
Jon Lillie
Contact email
Sponsor organisation
CHILDREN’S HOSPITAL LOS ANGELES (CHLA)
Duration of Study in the UK
0 years, 9 months, 4 days
Research summary
Paediatric acute respiratory distress syndrome (PARDS) accounts for >2% of paediatric intensive care unit (PICU) admissions with a mortality as high as 35%. Previous definitions of PARDS were based on adults but from 2015 there is consensus by The Pediatric Acute Lung Injury Consensus Conference Group (PALICC) on a new classification. It is not known in the UK or internationally how common PARDS is or what impact it has on children. This study will answer these questions and identify how PARDS is managed in the UK.
PARDIE is a multi-centre prospective study to identify how common new cases of PARDS are. Organised in the US, there are over 200 PICUs participating internationally. Led in the UK by GSTFT, the uptake has been excellent with the majority of UK PICUs agreeing to enrol.
This study is an observational, cross-sectional review of new cases of PARDS in PICUs involving 5 continuous days of screening and patient enrolment, occurring every 2 months over 6 months (4 total study weeks). There is no intervention.
Patients are followed up to 90 days post enrolment for outcomes such as mortality and length of ventilation.
The PARDIE study is subdivided into a main study (V0), three ancillary studies (V1, V2, V3), and two
complementary studies (V.4, Cardiac). V0 assesses whether the new severity classification effectively discriminates mortality. V1, V2 are trying to determine risk factors for mortality in PARDS and variability in management based on PARDS severity. V3’s objective is to determine the inter-observer reliability in the interpretation and prognostic relevance of chest imaging findings on the outcome of PARDS. V4 is to understand the feasibility of a PARDS prevention study by investigating the PALICC criteria for patients at risk of PARDS. Cardiac is to describe the number and frequency of children with cardiac disease who meet PALICC criteria for PARDS.REC name
London - Riverside Research Ethics Committee
REC reference
16/LO/1367
Date of REC Opinion
12 Aug 2016
REC opinion
Favourable Opinion