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临床试验/NCT05419336
NCT05419336已完成不适用

Child Growth and Development in East London

Queen Mary University of London1 个研究点 分布在 1 个国家目标入组 558 人开始时间: 2022年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
558
试验地点
1
主要终点
Feasibility and acceptability of the screening pilot

研究概览

简要总结

The overarching objective of this research is to detect poor growth and delayed development early in childhood by developing an automated growth-screening algorithm. The screening algorithm will be created using cohort data and piloted for feasibility and acceptability in Tower Hamlets. The ultimate goals are to detect linear growth failure and delayed development early to identify two groups of children: first, children with serious underlying medical disorders, in whom earlier diagnosis and management would improve clinical outcomes; and second, children whose poor growth and/or delayed development is a manifestation of socioeconomic disadvantage, in whom targeted pre-school interventions may improve long term health and education outcomes.

详细描述

Aim 1, Pilot an automated growth screening algorithm in Tower Hamlets

600 pre-school children at age 2-2.5 years will be enrolled into a pilot screening programme, following written informed parental consent. Children will be identified when they have their 2-2.5 year contact as part of the Healthy Child Programme. As per standard care, measures will be taken of the child's height using a stadiometer and weight using digital weighing scales. In addition to these measurements will be the child's head circumference, their height using a phone App and a record taken of previous anthropometric data including birthweight from the Personal Health Record. Parents' heights will also be recorded where possible. Next, families will be offered an additional height measurement at 3-3.5 years in the community, which is not currently part of standard care. Child height will then be recorded as part of the routine National Child Measurement Programme at 4-5 years of age, and linked to primary care data, enabling the growth-screening algorithm to be applied to these three data-points (2-2.5 years, 3-3.5 years and 4-5 years). At each height measurement the study team will identify the 2% of children with the poorest growth, in whom prior studies show a high prevalence (30-40%) of medical disorders and contact parents to offer referral to the paediatric endocrinology clinic at the Royal London Hospital. The study team will evaluate acceptability and feasibility of the screening and referral process, using parental and healthcare professional questionnaires. There will be an evaluation of the uptake by calculating the proportions screened, referred, investigated in clinic and diagnosed with medical disorders.

Focus group discussions will also be held with caregivers (one in English language and one in Sylheti) and with Health Visitors, to get an idea of how they feel about screening and identify potential barriers to a larger scale roll out.

Aim 2, Generate pilot data to investigate the best indicators to detect poor school readiness and/or developmental problems in early childhood.

As part of routine care, each child's development will be assessed using both the caregiver and professional components of the The Ages & Stages Questionnaire (ASQ-3). Following the 2-2.5 year contact, a subset of children (n = 150) will be invited to attend a separate appointment in the community to have a more detailed developmental assessment to measure gross motor, fine motor, social, language, visual-spatial and practical reasoning skills, conducted or supervised by a child psychologist. These data will be used to conduct sensitivity analyses to test the hypothesis that linear growth failure either alone or in combination with additional factors identifies children with reduced neurodevelopment, who are therefore at risk of poor school attainment.

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
24 Months 至 30 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged 2-2.5 years, who live in Tower Hamlets and whose caregiver(s) are willing to provide written informed consent

排除标准

  • The caregiver does not provide written informed consent
  • The child is not able to stand for an accurate height measurement

结局指标

主要结局

Feasibility and acceptability of the screening pilot

时间窗: 3 years

Feasibility will be assessed using Bowen et al.'s '8 areas of focus': acceptability, demand, implementation, practicality, adaptation, integration, expansion and limited-efficacy testing. To achieve this, a mixed methods evaluation will be employed including qualitative data collection using focus groups with caregivers and health visitors as well as questionnaires distributed to all caregiver participants in the study and all health visitors involved in growth and development assessments. Quantitative data will be collected on: uptake of growth measurements; number of successful growth and development measurements; number of referrals successfully completed (i.e. referred to child growth clinic with participant attending one clinic appointment); number of participants consenting to identification of their child's anthropometric data from National Child Measurement Programme; and uptake of the phone app.

次要结局

  • Linear Growth trajectory and child development(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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