Registry of Pulmonary Hypertension in Neonates (RePHyNe)
Research type
Research Database
IRAS ID
345248
Contact name
Nimish Subhedar
Contact email
Research summary
RePHyNe: Registry of Pulmonary Hypertension in Neonates
REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
24/NE/0175
Date of REC Opinion
11 Oct 2024
REC opinion
Favourable Opinion
Data collection arrangements
The Registry of Pulmonary Hypertension in Neonates (RePHyNe) is a prospective global multicenter observational cohort data collection study designed to collect clinical data from a patient's clinical care episode including routinely performed diagnostic tests and treatments delivered. Pseudo-anonymised, routinely collected clinical data items will be extracted from the participant's medical records by the local research team.
RePHyNe data will be collected via a series of eCRF's in REDCap, supporting the online submission of pseudo anonymised patient level data captured during routine care from approved data collection centres internationally. The database will be hosted on an accredited web based secure cloud server based in the UK.The RePHyNe Registry will collect diagnostic/clinical parameters and medications used to treat Neonatal PH in babies <3 months, significantly enhancing the quality of data available for clinical research.
Data items to be collected will include:
• Patient demographics (e.g. date of birth, gestation, birth weight)
• Clinical characteristics (e.g. concurrent diagnoses, measures of cardiorespiratory status)
• Respiratory support parameters (e.g. ventilator/oxygen requirement)
• Cardiovascular support (e.g. vasoactive medication)
• Diagnostic information (e.g. baseline echocardiographic parameters, laboratory tests)
• Clinical outcomes – short/long-term (e.g. mortality, chronic lung disease, long-term neurodevelopmental status)Research programme
Neonatal pulmonary hypertension (PH) is a relatively common complication, associated with a variety of conditions including extreme preterm birth (<28 weeks’ gestation), sepsis, congenital diaphragmatic hernia, meconium aspiration syndrome and structural cardiac disease. The reported incidence of early PH in extreme preterm infants is between 42-55% which approximates to 0.25% of all livebirths, an equivalent of ~1500 new PH cases p.a. associated with extreme preterm birth in the United Kingdom. There is an urgent need to improve our understanding of neonatal PH because of its increasing prevalence and risk of long-term mortality and morbidity in this population. A better understanding of the condition is essential to enable development of safe and effective preventative, diagnostic and treatment strategies. Studies to date are limited by a lack of a standardised case-definition, inconsistent data collection and poorly defined clinical outcomes. Results from published studies are further limited by their relatively small sample sizes reflecting the relative rarity of neonatal PH and difficulties in patient recruitment. The development of a patient registry will overcome many of these challenges and patient registries have proven value in other diseases, including paediatric and adult PH. There are currently no similar comprehensive registries in neonatal PH and we propose to create a novel registry focussed exclusively on babies < 3 months of age, corrected for prematurity.
Research database title
RePHyNe: Registry of Pulmonary Hypertension in Neonates
Establishment organisation
Liverpool Women's NHS Foundation Trust
Establishment organisation address
Crown Street
Liverpool
L8 7SS