Clinical Application and Functionality for an Application for Measurement of Head Circumference in Neonates and Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Criterion Validity(Vs Gold Standard)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants up to 18 months old seen in a paediatric clinic with a requirement for continuous head circumference measurements.
排除标准
- •Infants above the age of 18 months, Patients in emergency setting, Withdrawal of consent of parents/guardians
结局指标
主要结局
Criterion Validity(Vs Gold Standard)
时间窗: Day 0
Proof of concept of that the HCMA is an accurate and precise tool for measuring HC compared to standard practice (tape measure);
次要结局
- Reliability of parents/guardians in measurement of head circumference using the HCMA(Day 0)
- 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)
研究者
Mr Stefan Yordanov
Research Neurosurgical Registrar
University of Cambridge