MacrosomiaWECCNCT01136681
Wales Electronic Cohort for Children
An observational study of Macrosomia and Low Birth Weight, run by Swansea University at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Macrosomia, Low Birth Weight, Premature Birth
- How many people
- 900,000 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2009to Mar 2013
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 730,000 children born from 1990-2009, or subsequently resident, in Wales
Who may be able to join
- Present in routine data and recorded as born or resident in Wales (1998-2008)
Who cannot join
- Not recorded in routine data as being born of resident in Wales (1998-2008)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Department of Primary Care and Public Health
Cardiff, CF14 4YS
Health Information Research Unit
Swansea, Swansea, SA2 8PP
About this study
Official title: Wales Electronic Cohort for Children (WECC)
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.
Read more
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.
Read the detailed description
Lack of access to the enormous amount of information collected on children's health status and treatment has been a major contributor to both gaps in the translational pathway to improving child health at individual and population levels. The creation of the Wales Electronic Child Cohort is designed to remove this block and support both explanatory and interventional studies. This proposal is considered to be the best way to address this issue as it is built upon previous strategic investments by WORD and thus should achieve its goals in a very cost effective manner.
This type of E-Cohort with 35,000 additional children every year can answer questions where exposures, outcomes and potential confounders are routinely collected or available through individual or ecological linkages. This is a retrospective and prospective cohort, however, both cohort and nested case-control studies can be supported. Developments in geographical information systems (GIS), network analysis and the creation of a system for anonymising households means that is possible to anonymously link environmentally derived data to health data. The huge numbers of individuals involved in WECC means that the study has enormous power to answer important social, economic and health policy questions.
Examples of research questions which can be answered are:
- What factors determine the future health service need for individuals that are vulnerable at birth, and inform the development of interventions to reduce health inequalities for these groups?
- What is the influence of the social and physical environment on childhood obesity?
- What is the impact of health conditions in childhood on educational outcomes for children?
- Are birth anomalies more common in households in which any member received antibiotics during early pregnancy (marker for infectious cause)?
- What is the relationship between maternal depression, family composition and childhood injury risk?
- Can perinatal environmental and biological parameters be used to predict common illness such as asthma in later childhood and adults?
- To what extent can E-Cohorts replicate findings from traditional cohorts (e.g. Millennium Cohort Study) and replace the need for some non-routine data collection?
In this first instance we will focus on answering the first two questions.
- Conditions
- Macrosomia, Low Birth Weight, Premature Birth, Childhood Obesity, Poverty
- Keywords
- Anonymised Electronic Cohort, Record Linkage, Routine Data, Environment, Childhood Obesity, Low birth weight, Premature birth
- Medical subject headings
- Premature Birth, Pediatric Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight
Birth weight derived from routine data
Measured: not applicable due to routine data usage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2010 (estimated)
- Study startApr 2009
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MacrosomiaStudies 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
- Enrolment
- 900,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swansea University
- Sponsor type
- University, hospital or other
- Collaborators
- Cardiff University
- Responsible party
- Principal investigator, Dr Sarah E. Rodgers, Swansea University
- Investigators
- Ronan A Lyons, Principal investigator, Swansea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01136681
- Sponsor's protocol ID
- TPR08-006
- Acronym
- WECC
- Status last verified
- Dec 2014
- First submitted
- 2 Jun 2010
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wales Electronic Cohort for Children (WECC)
- ClinicalTrials.gov ID
- NCT01136681
- Acronym / sponsor ID
- WECC / TPR08-006
- Conditions
- Macrosomia, Low Birth Weight, Premature Birth, Childhood Obesity, Poverty
- Keywords
- Anonymised Electronic Cohort, Record Linkage, Routine Data, Environment, Childhood Obesity, Low birth weight, Premature birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 900,000 participants (actual)
- Lead sponsor
- Swansea UniversityUniversity, hospital or other
- Collaborators
- Cardiff University
- Study start
- Apr 2009
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 3 Jun 2010 (estimated)
- 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.
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.
Detailed description
Lack of access to the enormous amount of information collected on children's health status and treatment has been a major contributor to both gaps in the translational pathway to improving child health at individual and population levels. The creation of the Wales Electronic Child Cohort is designed to remove this block and support both explanatory and interventional studies. This proposal is considered to be the best way to address this issue as it is built upon previous strategic investments by WORD and thus should achieve its goals in a very cost effective manner.
This type of E-Cohort with 35,000 additional children every year can answer questions where exposures, outcomes and potential confounders are routinely collected or available through individual or ecological linkages. This is a retrospective and prospective cohort, however, both cohort and nested case-control studies can be supported. Developments in geographical information systems (GIS), network analysis and the creation of a system for anonymising households means that is possible to anonymously link environmentally derived data to health data. The huge numbers of individuals involved in WECC means that the study has enormous power to answer important social, economic and health policy questions.
Examples of research questions which can be answered are:
- What factors determine the future health service need for individuals that are vulnerable at birth, and inform the development of interventions to reduce health inequalities for these groups?
- What is the influence of the social and physical environment on childhood obesity?
- What is the impact of health conditions in childhood on educational outcomes for children?
- Are birth anomalies more common in households in which any member received antibiotics during early pregnancy (marker for infectious cause)?
- What is the relationship between maternal depression, family composition and childhood injury risk?
- Can perinatal environmental and biological parameters be used to predict common illness such as asthma in later childhood and adults?
- To what extent can E-Cohorts replicate findings from traditional cohorts (e.g. Millennium Cohort Study) and replace the need for some non-routine data collection?
In this first instance we will focus on answering the first two questions.
Study design
- Observational model
- Cohort
Who may qualify
- Ages
- Up to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 730,000 children born from 1990-2009, or subsequently resident, in Wales
Key inclusion criteria (1 listed)
- Present in routine data and recorded as born or resident in Wales (1998-2008)
Key exclusion criteria (1 listed)
- Not recorded in routine data as being born of resident in Wales (1998-2008)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Birth weight
Time frame: not applicable due to routine data usage
Birth weight derived from routine data
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 Dec 2014.
Related trials for Macrosomia
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Repeat Late GDM Testing and Cesarean Delivery Rates
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Ultrasound Estimation of Fetal Macrosomia at Term: Diagnostic Accuracy Within 24 Hours of Delivery
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Role of Body Composition in Large for Gestational Age Infants (LGA) With Oral Feeding Difficulty
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Estimation of Fetal Weight by Measuring Abdominal Circumference, Abdominal Subcutaneous Soft Tissue Thickness, Femur Length and Mid-thigh Soft Tissue Thickness
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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.
Ronan A Lyons principal investigator
Swansea University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macrosomia and Low Birth Weight, run by Swansea University at 2 sites 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 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Birth weight (time frame: not applicable due to routine data usage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2014.