Exploring right ventricular function applicability in a prediction model to identify preterm infants with early bronchopulmonary dysplasia (REPORT-BPD study): a mixed-methods observational cohort feasibility study protocol

Pilot and Feasibility Studies

Study Protocol

Jos Latour¹  Eirik Nestaas²  Joanne Hosking³  Wisam S. Muhsen⁴ 

[1] Faculty of Health, University of Plymouth, Plymouth, UK;Faculty of Health, University of Plymouth, Plymouth, UK;Institute of Clinical Medicine, University of Oslo, Oslo, Norway;Clinic of Pediatrics and Adolesence, Akershus University Hospital, Nordbyhagen, Norway;Medical Statistics, Faculty of Health, University of Plymouth, Plymouth, UK;Neonatal Intensive Care Unit, University Hospital Plymouth NHS Trust, Plymouth, UK;Faculty of Health, University of Plymouth, Plymouth, UK;

关键词: Right ventricular function;    Bronchopulmonary Dysplasia;    Prematurity;    Neonates;    Echocardiography;   

DOI  :  10.1186/s40814-022-01201-1

 received in 2022-06-03, accepted in 2022-11-09,  发布年份 2022

来源: Springer

【 摘 要 】

BackgroundBronchopulmonary dysplasia (BPD) is a chronic disease that affects the immature lungs of preterm infants. Infants born before 32 weeks of gestation are at a greater risk of developing BPD due to the need for respiratory support with higher oxygen requirement.Pulmonary vascular remodelling in early BPD can impose an additional burden on the right ventricle (RV) and RV dysfunction.This protocol outlines the study design and aims to formulate a prediction model to identify early BPD through the data generated from echo scans analysis.MethodsThe mixed-methods observational cohort feasibility study, which comprises three work-packages (WPs), will be conducted at the regional neonatal unit, University Hospital Plymouth, Plymouth, UK. WP-I will recruit 40 preterm infants; each participant will have two heart scans performed in the first ten days after birth (DABs).WP-II will collect the documentation of the participating preterm infants’ parents in the study neonatal unit diaries in the first 10 DABs. WP-III will involve semi-structured interviews of 10–15 parents of participating preterm infants and 10–15 health professionals who participated in WP-I.The study recruitment will be conducted over 18-months. The start date is 01 June 2022. WP-I and WP-II recruitment will occur during this period, while WP-III recruitment will occur during the second half. The results are expected to be submitted for publication by mid-2024.DiscussionThis paper outlines the study design. If the study successfully identifies the most sensitive echo parameter in recognising the RV dysfunction associated with early BPD, it will be an important finding in constructing an early BPD prediction model.Trial registrationClinicalTrials.gov Identifier is NCT05235399

【 授权许可】

CC BY   
© The Author(s) 2022

【 图 表 】

Fig. 1