The EPICure2 Study: educational and health outcomes at 11 years of age following extremely preterm birth

Plain English summary of protocol

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

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

University College London
University/education

Joint Research Office
Gower Street
London
WC1E 6BT
England
United Kingdom

"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Research council

Results and Publications

Study outputs

Editorial Notes

29/10/2021: The following changes have been made:
1. Publication references added.
2. The total final enrolment number has been added from the reference.
05/09/2017: Ethics approval information has been added.
09/02/2017: Internal review.