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

NCT05762848 | Completed

• 1 other identifier: Ver2
• Study Type: observational
• Target: 37
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Criterion Validity(Vs Gold Standard)

  Proof of concept of that the HCMA is an accurate and precise tool for measuring HC compared to standard practice (tape measure);

  Day 0

Secondary Outcomes (3)

• Repeatability and reliability

  Day 0

• Reliability of parents/guardians in measurement of head circumference with a tape measure (supervised by a health care professional);

  Day 0

• Reliability of parents/guardians in measurement of head circumference using the HCMA

  Day 0

Study Arms (2)

Researcher

Patients will have their Head circumference measured with a tape and with the mobile phone app.

Device: Mobile Phone Head Circumference App

Parent

Patients will have their Head circumference measured with a tape and with the mobile phone app.

Device: Mobile Phone Head Circumference App

Interventions

Mobile Phone Head Circumference App DEVICE

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

Parent; Researcher

Eligibility Criteria

• Age: Up to 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants up to 18 months with neurological disorders(attending Neurosurgery Clinics)

You may qualify if:

• Infants up to 18 months old seen in a paediatric clinic with a requirement for continuous head circumference measurements.

You may not qualify if:

• Infants above the age of 18 months, Patients in emergency setting, Withdrawal of consent of parents/guardians

Sponsors & Collaborators

• University of Cambridge: lead

Study Sites (1)

Addenbrookes Hospital

Cambridge, Cb2 0QQ, United Kingdom

Location

Related Publications (4)

• Cole TJ, Freeman JV, Preece MA. British 1990 growth reference centiles for weight, height, body mass index and head circumference fitted by maximum penalized likelihood. Stat Med. 1998 Feb 28;17(4):407-29.

  PMID: 9496720 BACKGROUND

• Dupont C, Castellanos-Ryan N, Seguin JR, Muckle G, Simard MN, Shapiro GD, Herba CM, Fraser WD, Lippe S. The Predictive Value of Head Circumference Growth during the First Year of Life on Early Child Traits. Sci Rep. 2018 Jun 29;8(1):9828. doi: 10.1038/s41598-018-28165-8.

  PMID: 29959368 RESULT

• Engle WA; American Academy of Pediatrics Committee on Fetus and Newborn. Age terminology during the perinatal period. Pediatrics. 2004 Nov;114(5):1362-4. doi: 10.1542/peds.2004-1915.

  PMID: 15520122 RESULT

• Sullivan JC, Tavassoli T, Armstrong K, Baron-Cohen S, Humphrey A. Reliability of self, parental, and researcher measurements of head circumference. Mol Autism. 2014 Jan 10;5(1):2. doi: 10.1186/2040-2392-5-2.

  PMID: 24410855 RESULT

Study Officials

• Ibrahim Jalloh, FRCS(Nsgy)

  University of Cambridge

  PRINCIPAL INVESTIGATOR

• Stefan Yordanov, MRCSed

  University of Cambridge

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Neurosurgical Registrar

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: March 10, 2023
• Study Start: November 1, 2022
• Primary Completion: January 15, 2023
• Study Completion: February 1, 2023
• Last Updated: March 10, 2023

Record last verified: 2023-02

Locations

GB (1)