Title of clinical study:Clinical application, validation, and functionality evaluation of the Mobile Head Circumference Application in neonates and children Sponsor: University Hospitals NHS Foundation Trust Purpose of study:Evaluate and validate the utility of the mobile Head Circumference application for use in the clinical and outpatient setting for evaluation of head circumference of neonates and infants Primary objectives:Evaluate usefulness of and feasibility of the application in the clinical setting comparing it to normal practice. Secondary objectives:Evaluate parent/guardian reliability and satisfaction of the use of the mobile head circumference app. Study Design:Prospective Sample Size:Treating clinicians employed by Cambridge University Hospitals NHS Foundation Trust will identify patients eligible for this study (infants \<18 months of age) and notify research team members with the patient's/guardian's consent. Once identified, research team members will approach patients' parents/guardians to seek informed consent before their clinic appointment or at the bedside on the ward. An information sheet will be used. If they choose to participate, we will measure the HC during the clinic appointment or on the ward. (Please refer to Flowchart 1). Sample size estimation was calculated with 90% statistical power to detect a change of means by 1 and a standard deviation of 1. This, along with 10% iteration, equals 33 participants. Summary of eligibility criteria:Neonatal patients and infants with need of continuous measurement of Head Circumference up to the age of 18months. Investigational techniques:Mobile application for Automatic measurement of head circumference.
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Criterion Validity(Vs Gold Standard)
Timeframe: Day 0