The development of a tool for objectifying infant head size and shape
Research type
Research Study
Full title
The development of a reliable tool for objectifying infant head size and shape
IRAS ID
332893
Contact name
Amy Davey
Contact email
Sponsor organisation
University of Bath
Clinicaltrials.gov Identifier
2335, University of Bath Ethics Application
Duration of Study in the UK
1 years, 8 months, 21 days
Research summary
Head size and shape (HSS) abnormalities in infants (aged 0-2 years) may represent underlying developmental issues, which could lead to life-changing differences if not identified and treated. Earlier recognition of such conditions leads to more timely and effective diagnosis/treatment, particularly with moderate to severe head shape differences to improve appearance. NICE guidelines recommend NHS head circumference and symmetry are measured using a disposable paper tape measure and advise to “not routinely refer [to specialists] if the baby is developing normally” (National Guideline Centre, 2023) even if asymmetry is present. Therefore, once high-risk conditions are eliminated, infant HSS measurement is not prioritised. Similarly, severity of head shape difference is rarely quantified during routine HSS assessment, as there is simply no method to quantify shape differences. There is a clear unmet clinical need and a requirement for investigation to improve infant HSS assessment, which will clarify pathways for treatment. By improving methods of taking, recording and transferring infant HSS assessment, more timely risk stratification can be made, for appropriate treatment.
This research is to investigate the methods of objectifying infant HSS and to develop a clinically viable infant HSS assessment tool to improve HSS assessment.
Phase 1: (a) a nationwide healthcare professionals’ pilot questionnaire to obtain broad views and practices of current HSS assessment (approximately n=20+); (b) systematic review to evaluate the current risk stratification methods of infant HSS, to establish the most reliable method for objectifying infant HSS; (c) followed by ten focus groups discussing infant HSS measurement, to obtain qualitative perspectives.
Phase 2: development of a software program tool for HSS analysis.
Phase 3: a two-group comparison study in two Bristol hospital NHS Trusts (estimated sample size up to n=132), to evaluate the differences between objective HSS classification outcomes from the new HSS assessment tool and standard (NICE) head measurements.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
26/SW/0040
Date of REC Opinion
1 May 2026
REC opinion
Further Information Favourable Opinion