title: Assessing the feasibility of injectable growth-promoting therapy in Crohn's disease.
abstract: BACKGROUND
  Despite optimal therapy, many children with Crohn's disease (CD) experience growth retardation. The objectives of the study are to assess the feasibility of a randomised control trial (RCT) of injectable forms of growth-promoting therapy and to survey the attitudes of children with CD and their parents to it.
  
  
  METHODS
  A feasibility study was carried out to determine study arms, sample size and numbers of eligible patients. A face-to-face questionnaire surveyed willingness to consent to future participation in the RCT. Eligibility to the survey was any child under 18 (with their parent/guardian) with CD whose height standard deviation score (HtSDS) was ≤+1. Of 118 questionnaires, 94 (80%) were returned (48 by children and 46 by parents).
  
  
  RESULTS
  The median age of the patients in the survey was 14.3 years (range 7.0 to 17.7), and 35 (73%) were male. Their median HtSDS was -1.2 (-3.01, 0.23), and it was lower than the median mid-parental HtSDS of -0.6 (-3.1, 1.4). We analysed the willingness of the children whose HtSDS <-1 to take part in the proposed RCT, being those most likely to require treatment. Overall, 18 (47%) children and 17 (46%) parents were willing. This increased to 61% of children who were slightly concerned about their height and 100% (4/4) of those very concerned. A common reason for not taking part in the RCT was fear of injections (44%); 111 children are required for randomisation into three study arms from nine centres.
  
  
  CONCLUSIONS
  Almost half of children and parents surveyed would take part in an RCT of growth-promoting therapy. Allaying fears about injections may result in higher recruitment rates.
authors.affiliation: Developmental Endocrinology Research Group, University of Glasgow, Scotland, UK ; Department of Paediatric Gastroenterology, Royal Hospital for Sick Children, Glasgow, UK.
authors.forename: Mabrouka A
authors.initials: MA
authors.lastname: Altowati
authors.affiliation: Medicines for Children Clinical Trials Unit, Clinical Trial Research Centre, University of Liverpool, Liverpool, UK.
authors.forename: Ashley P
authors.initials: AP
authors.lastname: Jones
authors.affiliation: Medicines for Children Clinical Trials Unit, Clinical Trial Research Centre, University of Liverpool, Liverpool, UK.
authors.forename: Helen
authors.initials: H
authors.lastname: Hickey
authors.affiliation: Medicines for Children Clinical Trials Unit, Clinical Trial Research Centre, University of Liverpool, Liverpool, UK.
authors.forename: Paula R
authors.initials: PR
authors.lastname: Williamson
authors.affiliation: Centre for Digestive Diseases, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, 4 Newark Street, London, E1 2AT UK.
authors.forename: Farah M
authors.initials: FM
authors.lastname: Barakat
authors.affiliation: Centre for Digestive Diseases, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, 4 Newark Street, London, E1 2AT UK.
authors.forename: Nicolene C
authors.initials: NC
authors.lastname: Plaatjies
authors.affiliation: Medicines for Children Clinical Trials Unit, Clinical Trial Research Centre, University of Liverpool, Liverpool, UK.
authors.forename: Ben
authors.initials: B
authors.lastname: Hardwick
authors.affiliation: Department of Paediatric Gastroenterology, Royal Hospital for Sick Children, Glasgow, UK.
authors.forename: Richard K
authors.initials: RK
authors.lastname: Russell
authors.affiliation: Medical and Pharmaceutical Statistics Research Unit, Department of Mathematics and Statistics, Lancaster University, Lancaster, UK.
authors.forename: Thomas
authors.initials: T
authors.lastname: Jaki
authors.affiliation: Developmental Endocrinology Research Group, University of Glasgow, Scotland, UK.
authors.forename: S Faisal
authors.initials: SF
authors.lastname: Ahmed
authors.affiliation: Centre for Digestive Diseases, Blizard Institute, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, 4 Newark Street, London, E1 2AT UK.
authors.forename: Ian R
authors.identifier: 0000-0002-9814-0161
authors.initials: IR
authors.lastname: Sanderson
keywords: Crohn’s disease; Growth hormone; Growth retardation; Inflammatory bowel disease; Insulin-like growth factor-1; Puberty