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Positive parental attitudes to participating in research involving newborn screened infants with CF

  • Researchers

    Chudleigh J, Hoo AF, Ahmed D, Prasad A, Sheehan D, Francis J, Buckingham S, Cowlard J, Thia L, Nguyen TT, Stocks J

  • Place of research

    On behalf of the London Cystic Fibrosis Collaboration (LCFC). Great Ormond Street Hospital for Children, London, UK

  • Publication

    Journal of Cystic Fibrosis / Oct 4 2012

  • Subjects

    , ,

  • How feasible is it to recruit babies diagnosed with CF by newborn screening (NBS)  into an observational research study within a few months after birth and what do parents feel about being involved in such research?

  • Why is this important?

    NBS for CF has recently been introduced throughout the UK and provides a welcome opportunity for early interventions to minimise progression of lung disease. However it is difficult to plan clinical trials unless we understand whether parents are willing to take part in research shortly after receiving news that their baby has CF, and how they feel about participating in such studies.

  • What did you do?

    We recruited NBS babies with CF who presented at one of six hospitals participating in the London CF Collaboration. Lung function tests at 3 and 12 months of age were performed at Great Ormond St Hospital/UCL Institute of Child Health. Infants with CF also had a combined bronchoscopy and chest CT scan at around 12 months of age during general anaesthesia, to detect any inflammation or structural changes in the lungs. These measurements allowed us to identify early signs of disease during the first year of life. Questionnaires were given to parents after the 3 and 12 month tests to find out how they felt about being involved in the study.

  • What did you find?

    Recruitment of NBS infants with CF was excellent, with 80% of all eligible infants participating at 3 months, 99% of whom returned for subsequent tests at one year.  Despite some inevitable anxieties, parental responses about the study were generally very positive, with 95% indicating they would recommend participation in such studies to other families.

  • What does this mean and reasons for caution?

    These results are reassuring and suggest that it is possible to recruit families of NBS CF infants into research studies shortly after diagnosis, even when follow-up requires some invasive investigations. Additional challenges would however need to be faced when recruiting into a randomised trial of different treatments (such as possible risks and issues relating to administering the treatment under test) rather than simply an observational study.

  • What's next?

    Further follow-up both at 2 years and then during the preschool years is currently in progress to determine whether results obtained in infancy are predictive of later lung function. This will help us to identify those children most in need of more intensive intervention from a young age.