Plain English Summary
Background and study aims
The national EPICure studies are concerned with the long term outcomes of babies who were born extremely premature (EP). EP births are only a small proportion of total births but they use a high proportion of resources in the newborn period, many needing 10 weeks or more intensive care. The high proportion of survivors with developmental problems is often highlighted in the press. The high risk of death or an impaired outcome is often used as a reason for not providing active support for these children. In 2006 a group of children born at <27 weeks of gestation (14 weeks or more before normal 'full term') were recruited and showed increased survival without impairment at 24 and 25 weeks of gestation compared with a similar, older study, which was carried out with children born in 1995. Of the children born in 2006, fewer infants at 3 years were found to have moderate to severe cerebral palsy (a condition that affects muscle control and movement) and had higher developmental scores when assessed. Because healthcare professional are continually trying to improve care, it is important to know that these important outcomes are improving. The aim of this study is to assess the progress of this important group of children at 11 years of age, to determine whether the early advantages found at three years of age have continued.
Who can participate?
Children who were born between 22-26 weeks gestation (pregnancy) whose mothers lived in London and Leicester and their nearby areas and children of the same age who were born at full term.
What does the study involve?
Children are visited either in school or at home and perform the assessment over the course of one school day. This involves completing a range of tests of mental function, educational ability and heart and lung assessments. Parents and teachers are also asked to fill in a number of questionnaires. All children have the same assessments and the results achieved by the extremely preterm children are compared to those of classmates.
What are the possible benefits and risks of participating?
Parents benefit from receiving test results from their children which can be used to discuss progress and support at school with their teachers. Any health issues identified are also reported to parents so that these issues can be discussed with the family doctor. There is a small risk that children may cough during lung function tests but often they are able to breathe easier following the medicine.
Where is the study run from?
The study is run from UCL Elizabeth Garret Anderson Institute for Women's Health and takes place in the community (UK)
When is the study starting and how long is it expected to run for?
June 2016 to July 2018
Who is funding the study?
Medical Research Council (UK)
Who is the main contact?
Dr Laura McCormack
epicure@ucl.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Dr Laura McCormack
ORCID ID
Contact details
The EPICure Studies
University College London Institute for Women's Health
74 Huntley Street
London
WC1E 6AU
United Kingdom
+44 20 3108 2045
epicure@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
v1 August 2016
Study information
Scientific title
The EPICure Studies: Outcome at 11 years for a national cohort of births between 22 and 26 weeks of gestation in England in 2006
Acronym
EPICure2@11
Study hypothesis
The aim of the study is to perform a multilevel study of the 1040 children identified in EPICure2 to determine changes in outcome since 1995 using a geographical sample in two geographic regions with assessments taking place in schools with classmates as controls (including 300 EP children and up to 300 controls).
Ethics approval
UCL Research Ethics Committee, 30/01/2017, ref: 10175/001
Study design
Longitudinal national cohort study
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Schools
Trial type
Other
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Birth between 22 and 26 weeks of gestation
Intervention
Children will be assessed in their school environment using a range of neuropsychological and education tests, and cardiorespiratory assessments over one school day. Information will also be sought by parental and teacher questionnaires, and a structured interview with parents. The attainments of the index extremely preterm cohort will be compared to that of classmates recruited for this study.
Intervention type
Other
Phase
Drug names
Primary outcome measures
IQ is measured using The Kaufmann-ABC (second edition) at 11 years of age.
Secondary outcome measures
1. Educational attainment is measured using teacher questionnaire, direct assessment (WIAT-II UK) and the results of national attainment tests at Key Stage 2
2. Behavioural outcomes will be measured using the Strengths and Difficulties Questionnaire, supplemented with the du Paul RS-IV scale for attentional problems and the Social Communication Questionnaire, which will be combined with the results of a post assessment parental interview using the Development and Wellbeing Assessment
3. Lung function measured using spirometry, exercise capacity (incremental walk test and 24h activity monitoring and clinical history
4. Blood pressure and augmentation index are measured using conventional blood pressure measurements and Doppler circulation assessment respectively
Overall trial start date
01/06/2016
Overall trial end date
31/07/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Birth during 2006
2. Born at 22-26 weeks of gestation
3. Mother resident in England
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1040 children
Participant exclusion criteria
1. Having moved outside the UK
2. Family has withdrawn from the study
Recruitment start date
01/01/2017
Recruitment end date
31/07/2018
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UCL Elizabeth Garret Anderson Institute for Women's Health
Huntley Street
London
WC1E 6AU
United Kingdom
Funders
Funder type
Research council
Funder name
Medical Research Council
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Planned publication in high impact peer review journal(s) in July 2019 and dissemination in national and international research meetings.
IPD Sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
31/07/2019
Participant level data
To be made available at a later date
Results - basic reporting
Publication summary