The RePHyNe Registry will initially be run as a pilot project over a two-year period. There are three phases of the pilot project.
This phase will identify a list of relevant data items to go into the Registry. The final dataset will contain various items including patient demographics, perinatal care, clinical diagnosis, cardiorespiratory status, diagnostic procedures, laboratory tests, therapeutic interventions and clinical outcomes. Selection of data fields for inclusion into the Registry database will be informed by a systematic review of clinical trials in neonatal PH, development of a Core Outcome Set and expert consensus within the Registry Advisory Group. A data dictionary will be compiled to define each data field. As data are collected, these definitions and outcomes will be evaluated regularly with respect to feasibility and utility.
A REDCap database will be built using the data items identified and agreed in phase 1. REDCap is a secure web application for building and managing online surveys and databases and using an online case report form. Patient data is stored on a secure server hosted by a commercial partner organisation with international data governance accreditation.
Prospective longitudinal data collection will start once phases 1 and 2 are complete and have been tested. Potential recruiting centres, who have previously expressed interest in joining the Registry, will be asked to submit data on patients meeting the Registry entry criteria. Consent will be sought from parents/guardians to submit patient data into the Registry. Each centre will be responsible for ensuring local data governance requirements are met before submitting data.