Long term follow up of children with congenital diaphragmatic hernia
Research type
Research Study
Full title
Patient Survey on Outcomes in Children with Congenital Diaphragmatic Hernia (CDH) to Identify Predictor’s for Poor Outcomes on Fetal Imaging
IRAS ID
209985
Contact name
Paolo De Coppi
Contact email
Sponsor organisation
Great Ormond Street Hospital
Clinicaltrials.gov Identifier
not applicable, not applicable
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Congenital diaphragmatic hernia (CDH) is a condition of unknown aetiology occurring in 1 in 2500 live births resulting from a failure in closure of the fetal diaphragm. The diaphragmatic defect results in herniation of the viscera in the embryonic period which then competes for space with the developing lungs. CDH lungs are underdeveloped resulting in respiratory insufficiency in the newborn. Apart from lung problems, these infants under-go a secondary insult which is post-natal closure of the diaphragmatic defect. Half of patients require patches to close the defect and of these one third re-herniate, the majority in the first two year. Chest wall deformities, gastro-oesphageal reflux disease (GERD), anti-reflux surgery and re-operation for obstructive episodes secondary to adhesions are all more common when primary repair is not possible.
Fetal imaging, magnetic resonant (MR) or ultrasound (US) scanning provides quantitative information on herniating viscera. This can not only be used to predict outcome but can offer more tailored information to be used in the counselling of parents. In this study we would like to look organ position and lung size on our fetal imaging, and establish if there is any relationship between pre-natal therapy and imaging with post-natal lung and gastrointestinal outcomes in survivors. Our partner centres, Barcelona (Maternitat) and Leuven (UZ) have a unique set of patients who undergo fetal intra-tracheal balloon placement in utero to stimulate lung growth.We would like to compare outcomes in these patients to the London population who are not offered fetal therapy to find out the long term effects of fetal therapy. We will give patients the opportunity to fill out questionnaires on gastrointestinal and respiratory outcomes. Secondly, we will collect medical data on prenatal and post-natal parameters.
REC name
West of Scotland REC 5
REC reference
18/WS/0108
Date of REC Opinion
15 Jun 2018
REC opinion
Favourable Opinion