Multicentre prospective observational study exploring the predictive value of functional echocardiographic indices for early identification of preterm neonates at risk of developing chronic pulmonary hypertension secondary to chronic neonatal lung disease

Laura Thomas; Michelle Baczynski; Poorva Deshpande; Ashraf Kharrat; Sébastien Joye; Faith Zhu; Daniel Ibarra-Rios; Prakesh S Shah; Luc Mertens; Robert P Jankov; Xiang Y Ye; Elaine Neary; Joseph Ting; Michael Castaldo; Philip Levy; Aisling Smith; Afif F El-Khuffash; Regan E Giesinger; Patrick J McNamara; Dany E Weisz; Amish Jain

doi:10.1136/bmjopen-2020-044924

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Multicentre prospective observational study exploring the predictive value of functional echocardiographic indices for early identification of preterm neonates at risk of developing chronic pulmonary hypertension secondary to chronic neonatal lung disease

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Multicentre prospective observational study exploring the predictive value of functional echocardiographic indices for early identification of preterm neonates at risk of developing chronic pulmonary hypertension secondary to chronic neonatal lung disease

Laura Thomas, Michelle Baczynski, Poorva Deshpande, Ashraf Kharrat, Sébastien Joye, Faith Zhu, Daniel Ibarra-Rios, Prakesh S Shah, Luc Mertens, Robert P Jankov, …

BMJ open, Vol.11(3), pp.e044924-e044924

03/31/2021

DOI: 10.1136/bmjopen-2020-044924

PMCID: PMC8016080

PMID: 33789855

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Abstract

IntroductionAlthough chronic pulmonary hypertension (cPH) secondary to chronic neonatal lung disease is associated with increased mortality and respiratory and neurodevelopmental morbidities, late diagnosis (typically ≥36 weeks postmenstrual age, PMA) and the use of qualitative echocardiographic diagnostic criterion (flat interventricular septum in systole) remain significant limitations in clinical care. Our objective in this study is to evaluate the utility of relevant quantitative echocardiographic indices to identify cPH in preterm neonates, early in postnatal course and to develop a diagnostic test based on the best combination of markers.Methods and analysisIn this ongoing international prospective multicentre observational diagnostic accuracy study, we aim to recruit 350 neonates born <27 weeks PMA and/or birth weight <1000 g and perform echocardiograms in the third week of age and at 32 weeks PMA (early diagnostic assessments, EDA) in addition to the standard diagnostic assessment (SDA) for cPH at 36 weeks PMA. Predefined echocardiographic markers under investigation will be measured at each EDA and examined to create a scoring system to identify neonates who subsequently meet the primary outcome of cPH/death at SDA. Diagnostic test characteristics will be defined for each EDA. Pulmonary artery acceleration time and tricuspid annular plane systolic excursion are the primary markers of interest.Ethics and disseminationEthics approval has been received by the Mount Sinai Hospital Research Ethics Board (REB) (#16-0111-E), Sunnybrook Health Sciences Centre REB (#228-2016), NHS Health Research Authority (IRAS 266498), University of Iowa Human Subjects Office/Institutional Review Board (201903736), Rotunda Hospital Research and Ethics Committee (REC-2019-008), and UBC Children’s and Women’s REB (H19-02738), and is under review at Boston Children’s Hospital Institutional Review Board. Study results will be disseminated to participating families in lay format, presented to the scientific community at paediatric and critical care conferences and published in relevant peer-reviewed journals.Trail registration numberNCT04402645.

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Title: Subtitle: Multicentre prospective observational study exploring the predictive value of functional echocardiographic indices for early identification of preterm neonates at risk of developing chronic pulmonary hypertension secondary to chronic neonatal lung disease
Creators: Laura Thomas - Sinai Health System
Michelle Baczynski - Sinai Health System
Poorva Deshpande - University of Toronto
Ashraf Kharrat - University of Toronto
Sébastien Joye - University of Lausanne
Faith Zhu - Sinai Health System
Daniel Ibarra-Rios - Hospital Infantil de México Federico Gómez
Prakesh S Shah - University of Toronto
Luc Mertens - Hospital for Sick Children
Robert P Jankov - University of Ottawa
Xiang Y Ye - Sinai Health System
Elaine Neary - Liverpool Women's Hospital
Joseph Ting - University of British Columbia
Michael Castaldo - University of British Columbia
Philip Levy - Boston Children's Hospital
Aisling Smith - Rotunda Hospital
Afif F El-Khuffash - Rotunda Hospital
Regan E Giesinger - University of Iowa
Patrick J McNamara - University of Iowa
Dany E Weisz - Sunnybrook Health Science Centre
Amish Jain - Sinai Health System
Resource Type: Journal article
Publication Details: BMJ open, Vol.11(3), pp.e044924-e044924
DOI: 10.1136/bmjopen-2020-044924
PMID: 33789855
PMCID: PMC8016080
NLM abbreviation: BMJ Open
ISSN: 2044-6055
eISSN: 2044-6055
Grant note: name: SickKids Foundation-Canadian Institute of Child Health (SKF-CIHR) New Investigator Research Grant, award: 154860; DOI: 10.13039/100004411, name: Heart and Stroke Foundation of Canada, award: 2019/20 HSFC Clinician Scientist (Phase 2) Award
Language: English
Date published: 03/31/2021
Academic Unit: Stead Family Department of Pediatrics; Neonatology; Internal Medicine
Record Identifier: 9984353834002771

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