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Clinical Application and Functionality for an Application for Measurement of Head Circumference.

NCT05762848 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 37

Last updated 2023-03-10

No results posted yet for this study

Summary

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.

Conditions

  • Hydrocephalus in Infants

Interventions

DEVICE

Mobile Phone Head Circumference App

Measurement of Head circumference of Babies/Infants with a mobile phone application.

Sponsors & Collaborators

Principal Investigators

  • Ibrahim Jalloh, FRCS(Nsgy) · University of Cambridge

  • Stefan Yordanov, MRCSed · University of Cambridge

Eligibility

Max Age
18 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2023-01-15
Completion
2023-02-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05762848 on ClinicalTrials.gov