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
Prakesh S Shah,
Joseph Ting,
Aisling Smith,
Luc Mertens,
Laura Thomas,
Xiang Y Ye,
Dany E Weisz,
Amish Jain,
Faith Zhu,
Michelle Baczynski,
Poorva Deshpande,
Ashraf Kharrat,
Sébastien Joye,
Daniel Ibarra-Rios,
Robert P Jankov,
Elaine Neary,
Michael Castaldo,
Philip Levy,
Afif F El-Khuffash,
Regan E Giesinger,
Patrick J McNamara
Affiliations
Prakesh S Shah
3 Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada
Joseph Ting
Neonatology, The University of British Columbia, Vancouver, Ontario, Canada
Aisling Smith
Neonatology, Rotunda Hospital, Dublin, Ireland
Luc Mertens
Department of Paediatrics, Division of Cardiology, The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada
Laura Thomas
4 Liverpool John Moores University, Liverpool, UK
Xiang Y Ye
MiCare Research Center, Mount Sinai Hospital, Toronto, Ontario, Canada
Dany E Weisz
9 Newborn and Developmental Paediatrics, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada
Amish Jain
Paediatrics, University of Toronto, Toronto, Ontario, Canada
Faith Zhu
2 Department of Paediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada
Michelle Baczynski
4 Department of Respiratory Therapy, Mount Sinai Hospital, Toronto, Ontario, Canada
Poorva Deshpande
2 Department of Paediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada
Ashraf Kharrat
2 Department of Paediatrics, Mount Sinai Hospital, Toronto, Ontario, Canada
Sébastien Joye
1 Department Mother-Woman-Child, Clinic of Neonatology, Lausanne University Hospital and University of Lausanne, Lausanne, Switzerland
Daniel Ibarra-Rios
Neonatology, Hospital Infantil de Mexico Federico Gomez, Mexico City, Mexico
Robert P Jankov
Division of Neonatology, Department of Paediatrics, University of Ottawa, Ottawa, Ontario, Canada
Elaine Neary
Neonatology, Liverpool Womens Hospital NHS Foundation Trust, Liverpool, UK
Michael Castaldo
1 Department of Pediatrics, Faculty of Medicine, The University of British Columbia & BC Women`s Hospital, Vancouver, British Columbia, Canada
Philip Levy
Pediatrics, Harvard Medical School, Boston, Massachusetts, USA
Afif F El-Khuffash
Neonatology, Rotunda Hospital, Dublin, Ireland
Regan E Giesinger
1 Pediatrics, University of Iowa, Iowa City, Iowa, USA
Patrick J McNamara
7 Department of Pediatrics and Internal Medicine, University of Iowa, Iowa City, Iowa, USA
Introduction Although 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 analysis In 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 dissemination Ethics 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 number NCT04402645.
