Rapid, standardised neurodevelopment surveillance: INTER-NDA
Research type
Research Study
Full title
Rapid, standardised neurodevelopment surveillance at age 2 years in neonatal follow-up clinics on the INTERGROWTH-21st Neurodevelopment Assessment (INTER-NDA): A Feasibility Study
IRAS ID
327510
Contact name
Jon Dorling
Contact email
Sponsor organisation
R&D Department
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
This study aims to prospectively examine the feasibility of applying a novel, standardised international neurodevelopment assessment (the INTERGROWTH-21st Project Neurodevelopment Assessment; INTER-NDA) in the setting of busy neonatal follow-up clinics to identify cognitive, motor and language delays and behavioural problems in neonatal ICU (NICU) graduates at their routine 2-year follow-up neonatal outpatient (OP) clinic appointment at University Hospitals Southampton NHS Foundation Trust (UHS NHS FT). This is important as currently NICU graduates who are not born extremely preterm or with significant neurological morbidity in the period following birth do not received standardized, direct neuropsychometric assessments (such as the Bayley Scales of Infant Development). Rather, they are followed up using either unstandardized clinical developmental examinations (which vary between clinicians); a parent reported questionnaire (the Ages and Stages Questionnaire, ASQ) or a combination of both. These strategies are at high risk of inter-clinician variability, caregiver biases and, as such, do not fulfil the national requirements for standardised developmental surveillance at age 2 years. The INTER-NDA is a novel, rapid, standardised neurodevelopmental test, with short administration times (15 minutes), cross-cultural applicability, and which can be reliably administered by non-specialist healthcare professionals. Its norms are the only existent neurodevelopmental standards (as opposed to references) for 2 year olds constructed according to the WHO’s prescriptive guidelines and complementing the WHO’s international child growth standards and the INTERGROWTH-21st Project’s international fetal growth standards. The INTER-NDA, therefore, is well placed to provide a solution to fulfil this unmet patient need without increasing the workload on neonatal follow-up services. The INTER-NDA has demonstrated high levels of agreement with the BSID-III in term-born, low-risk infants however, its clinical utility and feasibility of implementation in NICU graduates and preterm infants during routine neonatal OP clinic follow-up is unknown. We will recruit a convenience sample of forty NICU graduates from the routine neonatal follow-up clinics at UHSFT at 2 years corrected gestational age between June and September 2023. Each participant will be will be evaluated on the INTER-NDA and parents will be asked to complete two parent report questionnaire (the ASQ, which is standard of care at UHS NHS FT but does not form part of the national recommendations for neonatal follow-up, and the Parent Report of Children's Abilities – Revised (PARCA-R) which is not standard of care at UHS FT but is recommended by the current National Institute for Health and Care Excellence (NICE) guidelines for neonatal follow-up). Parent experiences to standard of care and to the INTER-NDA will be collected on the Experience of Service Questionnaire. We will assess the feasibility acceptability, and agreement between the INTER-NDA and (1) UHS NHS FT’s and (2) NICE recommended standards of care; and compare the opportunity costs and parent experience scores between the INTER-NDA and the two groups. This study has important implications in examining a potential improvement in current service provision without increasing the workload on neonatal follow-up services. This would provide benefit to parents and infants alike by facilitating the rapid early identification of developmental delays using standardised methodology; reducing inter-clinician variability in service provision, and meeting national and international health service recommendations for the developmental surveillance of NICU graduates. If successful, this project would provide evidence to support a larger initiative to scale up standardised neonatal follow-up on the INTER-NDA, thereby addressing long-waiting times for clinical appointments as well as reducing workloads on service providers.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
23/WM/0142
Date of REC Opinion
17 Jul 2023
REC opinion
Further Information Favourable Opinion