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Clinical Trials/NCT05419336
NCT05419336
Completed
Not Applicable

Child Growth and Development in East London

Queen Mary University of London1 site in 1 country558 target enrollmentJuly 15, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stunted Growth
Sponsor
Queen Mary University of London
Enrollment
558
Locations
1
Primary Endpoint
Feasibility and acceptability of the screening pilot
Status
Completed
Last Updated
11 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
July 15, 2022
End Date
September 30, 2024
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Feasibility and acceptability of the screening pilot

Time Frame: 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.

Secondary Outcomes

  • Linear Growth trajectory and child development(3 years)

Study Sites (1)

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