Hydrocephalus in InfantsNCT05762848
Clinical Application and Functionality for an Application for Measurement of Head Circumference.
An observational study of Hydrocephalus in Infants, run by University of Cambridge at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages Up to 18 months
- Conditions the study is for
- Hydrocephalus in Infants
- What is being tested?
- Mobile Phone Head Circumference App
- Type of treatment
- Medical device
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Nov 2022to 1 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 months
- All sexes
- No healthy volunteers
- Child
Study population: Infants up to 18 months with neurological disorders(attending Neurosurgery Clinics)
Who may be able to join
- Infants up to 18 months old seen in a paediatric clinic with a requirement for continuous head circumference measurements.
Who cannot join
- Infants above the age of 18 months, Patients in emergency setting, Withdrawal of consent of parents/guardians
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Application and Functionality for an Application for Measurement of Head Circumference in Neonates and Children
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
Read more
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.
Read the detailed description
An accurate head circumference (HC) measurement is a quick and cost-effective assessment which is essential when clinically evaluating a neonate or infant. HC outside the normal range may indicate a disorder of brain development, hydrocephalus, or an intracranial mass lesion. The growth pattern of HC, determined from serial measurements, also provides useful clinical information. For example, changes in HC are used to help determine whether hydrocephalus needs treatment. HC growth is also predictive of neurodevelopmental outcomes. [Lippé et al. 2018]
HC is measured by measuring the widest circumference of the head with a tape measure. Typically, this is performed by health care workers, but parents can be taught to take measurements reliably. With the increasing use of telephone and virtual clinics as a substitute to face-to-face appointments, parental measurement of HC is increasingly used to help guide clinical management in a wide variety of clinical specialties including Neurosurgery, Neonatology, Paediatrics, and General Practice.
Tape measure HC measurements are prone to error, particularly when performed by parents, due to individual differences in head shape, hair style and texture, subject cooperation, and examiner differences in tape measure placement and tautness.6 There is therefore the need for a more reliable method.
Rationale for the study:
We have developed a HC mobile application (HCMA) that can measure the head circumference of an infant and plot it against standardised growth charts.
The rationale of this study is to validate the HCMA in a clinical setting and to review its usability by parents in the community.
Research objective and purpose
The main objective of the study is to validate the accuracy of the HC app and to prove its utility and feasibility in clinical practice.
Secondary objectives will be to evaluate parent/guardian reliability and satisfaction of using the HC app.
Primary Objective:
Hypothesis 1: There is no statistically significant difference between HC measured with a tape measure and HC measured with HCMA;
Secondary Objectives:
Hypothesis 2: Intra-rater Reliability(precision/repeatability) - The variability of series of three measurements of HC using HCMA (performed by a healthcare professional) is within 0.5 cm -(the standard error margin for measurement measurements) Hypothesis 3: Inter-rater Reproducibility - HC measurements made using the HCMA will not be significantly different when measured by parents or healthcare professionals we will then compare measurements of HC using HCMA performed by healthcare professional with the measurements performed by the parents/guardians using the HCMA. These should be within the standard error of margin for the measurement with tape measure.
Hypothesis 4: Parents are satisfied using the HCMA and find it easy to use'
- Conditions
- Hydrocephalus in Infants
- Being tested
- Mobile Phone Head Circumference App
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Phone Head Circumference AppDevice
Measurement of Head circumference of Babies/Infants with a mobile phone application.
| Study group | Role | What they receive |
|---|---|---|
| Researcher | Patients will have their Head circumference measured with a tape and with the mobile phone app. Receives: Device: Mobile Phone Head Circumference App | |
| Parent | Patients will have their Head circumference measured with a tape and with the mobile phone app. Receives: Device: Mobile Phone Head Circumference App |
What is being measured
The primary outcome is the main question the study is designed to answer.
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);
Measured: Day 0
Secondary outcomes (3)
Repeatability and reliability
Within-rater variability using three consecutive measurements with HCMA by a health care professional;
Measured: Day 0
Reliability of parents/guardians in measurement of head circumference with a tape measure (supervised by a health care professional);
Measured: Day 0
Reliability of parents/guardians in measurement of head circumference using the HCMA
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start1 Nov 2022
- Primary completion15 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hydrocephalus in InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cambridge
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mr Stefan Yordanov, University of Cambridge
- Investigators
- Ibrahim Jalloh, FRCS(Nsgy), Principal investigator, University of CambridgeStefan Yordanov, MRCSed, Principal investigator, University of Cambridge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05762848
- Sponsor's protocol ID
- Ver2
- Status last verified
- Feb 2023
- First submitted
- 16 May 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 9496720Dupont 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.
PubMed 29959368Engle 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.
PubMed 15520122Sullivan 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.
PubMed 24410855
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Application and Functionality for an Application for Measurement of Head Circumference in Neonates and Children
- ClinicalTrials.gov ID
- NCT05762848
- Acronym / sponsor ID
- Ver2
- Conditions
- Hydrocephalus in Infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of CambridgeUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 15 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
An accurate head circumference (HC) measurement is a quick and cost-effective assessment which is essential when clinically evaluating a neonate or infant. HC outside the normal range may indicate a disorder of brain development, hydrocephalus, or an intracranial mass lesion. The growth pattern of HC, determined from serial measurements, also provides useful clinical information. For example, changes in HC are used to help determine whether hydrocephalus needs treatment. HC growth is also predictive of neurodevelopmental outcomes. [Lippé et al. 2018]
HC is measured by measuring the widest circumference of the head with a tape measure. Typically, this is performed by health care workers, but parents can be taught to take measurements reliably. With the increasing use of telephone and virtual clinics as a substitute to face-to-face appointments, parental measurement of HC is increasingly used to help guide clinical management in a wide variety of clinical specialties including Neurosurgery, Neonatology, Paediatrics, and General Practice.
Tape measure HC measurements are prone to error, particularly when performed by parents, due to individual differences in head shape, hair style and texture, subject cooperation, and examiner differences in tape measure placement and tautness.6 There is therefore the need for a more reliable method.
Rationale for the study:
We have developed a HC mobile application (HCMA) that can measure the head circumference of an infant and plot it against standardised growth charts.
The rationale of this study is to validate the HCMA in a clinical setting and to review its usability by parents in the community.
Research objective and purpose
The main objective of the study is to validate the accuracy of the HC app and to prove its utility and feasibility in clinical practice.
Secondary objectives will be to evaluate parent/guardian reliability and satisfaction of using the HC app.
Primary Objective:
Hypothesis 1: There is no statistically significant difference between HC measured with a tape measure and HC measured with HCMA;
Secondary Objectives:
Hypothesis 2: Intra-rater Reliability(precision/repeatability) - The variability of series of three measurements of HC using HCMA (performed by a healthcare professional) is within 0.5 cm -(the standard error margin for measurement measurements) Hypothesis 3: Inter-rater Reproducibility - HC measurements made using the HCMA will not be significantly different when measured by parents or healthcare professionals we will then compare measurements of HC using HCMA performed by healthcare professional with the measurements performed by the parents/guardians using the HCMA. These should be within the standard error of margin for the measurement with tape measure.
Hypothesis 4: Parents are satisfied using the HCMA and find it easy to use'
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Researcher | – | Device: Mobile Phone Head Circumference AppPatients will have their Head circumference measured with a tape and with the mobile phone app. |
| Parent | – | Device: Mobile Phone Head Circumference AppPatients will have their Head circumference measured with a tape and with the mobile phone app. |
Who may qualify
- Ages
- Up to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Infants up to 18 months with neurological disorders(attending Neurosurgery Clinics)
Key inclusion criteria (1 listed)
- Infants up to 18 months old seen in a paediatric clinic with a requirement for continuous head circumference measurements.
Key exclusion criteria (1 listed)
- Infants above the age of 18 months, Patients in emergency setting, Withdrawal of consent of parents/guardians
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Phone Head Circumference AppMeasurement of Head circumference of Babies/Infants with a mobile phone application. | Device | Parent, Researcher |
Primary outcome
Criterion Validity(Vs Gold Standard)
Time frame: Day 0
Proof of concept of that the HCMA is an accurate and precise tool for measuring HC compared to standard practice (tape measure);
3 secondary outcomes
Repeatability and reliability
Time frame: Day 0
Reliability of parents/guardians in measurement of head circumference with a tape measure (supervised by a health care professional);
Time frame: Day 0
Reliability of parents/guardians in measurement of head circumference using the HCMA
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
- Background: PubMed 9496720Cole 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.
- Results publication: PubMed 29959368Dupont 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.
- Results publication: PubMed 15520122Engle 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.
- Results publication: PubMed 24410855Sullivan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ibrahim Jalloh, FRCS(Nsgy) principal investigator
University of Cambridge
Stefan Yordanov, MRCSed principal investigator
University of Cambridge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hydrocephalus in Infants, run by University of Cambridge at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Criterion Validity(Vs Gold Standard) (time frame: Day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05762848, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.