NCT01136681

Brief Summary

The investigators are developing a research platform capable of improving children's health through the generation of knowledge from analysis of routinely collected data from within and outside the health service. The investigators are using the data that are routinely collected in Wales to answer specific questions about child health and well-being, with the aim of informing policy and practice in Wales, whilst also being internationally relevant. Routinely collected datasets are publicly funded, and have already been incorporated into the Secure Anonymised Information Linkage databank. The investigators are combining these datasets on children from health and social care to establish an anonymised Wales wide Electronic Cohort for Children (WECC). WECC will serve as the platform for future work in translating information into child population health policy. There are 35,000 births in Wales per year, and data are available for the previous ten years. Thus, WECC will be sufficiently powered to answer important social, economic and health policy questions. WECC will also act as a demonstration project which would inform the development of e-cohorts to support translational research across the life course and disease spectrum.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
900,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

June 2, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 3, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 10, 2014

Status Verified

December 1, 2014

Enrollment Period

3.9 years

First QC Date

June 2, 2010

Last Update Submit

December 9, 2014

Conditions

Keywords

Anonymised Electronic CohortRecord LinkageRoutine DataEnvironmentChildhood ObesityLow birth weightPremature birth

Outcome Measures

Primary Outcomes (1)

  • Birth weight

    Birth weight derived from routine data

    not applicable due to routine data usage

Eligibility Criteria

AgeUp to 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

730,000 children born from 1990-2009, or subsequently resident, in Wales

You may qualify if:

  • Present in routine data and recorded as born or resident in Wales (1998-2008)

You may not qualify if:

  • Not recorded in routine data as being born of resident in Wales (1998-2008)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Health Information Research Unit

Swansea, Swansea, SA2 8PP, United Kingdom

Location

Department of Primary Care and Public Health

Cardiff, CF14 4YS, United Kingdom

Location

MeSH Terms

Conditions

Premature BirthPediatric Obesity

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ronan A Lyons

    Swansea University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Ronan Lyons

Study Record Dates

First Submitted

June 2, 2010

First Posted

June 3, 2010

Study Start

April 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 10, 2014

Record last verified: 2014-12

Locations