EPICure2@11 - Outcome at 11 years for a national cohort of births between 22 and 26 weeks of gestation in England in 2006

The national EPICure studies are concerned with the long term outcomes of babies who are born at extremely premature (EP) gestations. Births at these gestations form only a small proportion of total births but they consume a high proportion of resources in the newborn period, many needing 10 weeks or more intensive care. The high proportion of survivors with impairments and disabilities 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 we recruited the EPICure2 cohort of births <27 weeks of gestation (14 weeks or more before normal 'full term') and demonstrated increased survival without impairment at 24 and 25 weeks over our first study in 1995. Intriguingly we also found less infants at 3 years with moderate to severe cerebral palsy and higher developmental scores in those we assessed. In the event we only managed to evaluate just over half of the 1000 survivors and some doubt remains as to the true size of improvement in outcomes for this group.

We therefore propose to carry out a further assessment on this population when they are around 11 years of age (in the top year of junior school). We have chosen this age because at this age we can investigate the detail of learning and behaviour in more detail than at earlier ages and obtain novel information about the underlying problems faced by EP children; furthermore, the findings are more likely to be predictive of eventual progress across adolescence, and finally we also examined the 1995 cohort at 11 years and 19 years, so the results can be compared and the predictive value of the findings assessed. We will assess the population in two ways:

Firstly, we will obtain information on all EPICure2 births from the national pupil database, which carries information on the school attainment up to 11 years (and beyond). This will allow us to evaluate the attainment great majority of the cohort and give us clear information on their school progress, need for special educational support, etc. It will provide unique information rapidly but will be anonymised as we do not have permission from all parents; thus it will only be able to tell us broad outcomes.

Secondly, we will examine EPICure2 children in two areas (North London and East Midlands) to provide us with a school based assessment of the detailed outcome of the learning and thinking issues faced by these children compared to a group of their classmates using robust methodology, as we have before. We will also test their breathing and blood vessel function directly and, using questionnaires and an interview, evaluate their behaviour. This will allow us to understand where the improvements in outcomes have occurred that we expect, compared to those in the 1995 births, and allow us to make predictions for the future. We will also interview parents to gain their perspective on the problems of EP birth,

This study will thus provide information of value to parents of extremely premature children as to the problems they may face in the future, it will help doctors understand how the advances in care up to 2006 have changed these long term outcomes and it will provide insights into the mechanisms by which these problems arise and may be tackled.

This programme of research will evaluate different aspects of outcome following birth before 27 week of gestation for a national cohort of births in England in 2006 at 11 years of age (EPICure2). Over 1000 survivors have been identified and traced using their family doctors. The study will provide novel explanatory information about the nature of the defects in this population, allow investigation of the relationships with perinatal events and comparison with births in 1995 and determine the predictive accuracy of previous findings carried out at 3 years of age.

We will carry out a two level investigation:

1. Whole population using the Department for Education National Pupil Database to provide anonymised data on scholastic achievement and special needs. In another study we have obtained information covering 97% of 6295 children in the ORACLE Children Study. This will provide us with outcome by gestational age, birthright, sex and neonatal network in a unique analysis. This will allow a maximum follow up rate as all schools are included in the Key Stage 2 assessments, which are reported as continuous measures alongside

2. A sample of survivors in the East Midlands (n~170 survivors) and North London (n~170 survivors; Sample 1) utilising a school based assessment of educational, behavioural and cognitive function alongside randomly selected comparison children from their peer group. Alongside this we will carry out respiratory function testing, cardiovascular assessment and
CP Exercise testing to provide a measure of their somatic impairment as they enter adolescence.

This application helps to develop an already productive multidisciplinary partnership between neonatal medicine, psychology, cardiorespiratory medicine, and neuroscience to provide a state-of-the-art study to inform clinicians, parents and scientists of the effects of birth 22-26 weeks of gestation on pre-adolescent outcome

EPICure has contributed greatly to the knowledge economy about extremely preterm birth, raising awareness of the problems faced following intensive care for these babies, influencing policy and practice within the neonatal community, through national bodies such as the Nuffield Council on Bioethics, the House of Commons Science and Technology Committee and national guidance - most recently from the RCOG. EPICure 2 has revisited much of the original data, indicating where change is necessary.
We believe that the data from these new studies at 11 years will impact a range of areas in academia, health and education. This study will generate novel research ideas, identifying areas to investigate further, and generating targets for interventions. We will achieve this through a range of pathways - publications and presentations, open access, awareness through active engagement of the medical and public media and press release collaboration. It is important to understand the full impact and implications of preterm birth; provision of services and support for families, raising awareness of the ongoing needs and problems of prematurity through education of professionals in health and education, ensuring that resources are available for interventions to support children at home, in the family and at school will be informed by this research.

Pathways -
(a) public lectures to specialty groups and associated publications, working with educational research teams to determine the optimal way of influencing teachers and teaching styles, web resources and publication in educational journals.

(b) determining risk for cardiovascular and respiratory outcomes will inform adult services and may indicate active management of this group who have relatively little health promotion and surveillance of direct relevance

(c) via media and opinion pieces, supported by web based information to ensure a high profile of information.

(d) we also work with public engagement - to raise the public knowledge of the effects of prematurity through
(i) work with charitable organisations via lectures for a range of national and local charities and preterm PPI groups at educational and fundraising events;
(ii) maintaining our website as an effective way to promote the findings of the study and the interpretation of results for the public;
(iii) ensuring media exposure for results of key results.

(e) Public policy - influencing service design and configuration (e.g. the new NICE guidance on follow up of preterm babies); working with Bliss and health economists to evaluate the cost effectiveness of different models of care on the outcomes - pathways using Bliss to disseminate information and lobby policy makers to move to more appropriate models.

Through evaluating adolescent outcomes we aim to improve understanding of the risk-benefit of neonatal care, as survival and outcomes are improving continually.