SaFE: Swallowing, feeding and eating in children born with OA/TOF
Research type
Research Study
Full title
A mixed methods exploration of early feeding in children born with oesophageal atresia/trache-oesophageal fistula.
IRAS ID
262966
Contact name
Alexandra Stewart
Contact email
Sponsor organisation
Great Ormond Street Hospital for Children NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 2 months, 24 days
Research summary
How does oesophageal atresia/trache-oesophageal fistula affect feeding and swallowing in the first year of life?
Approximately 150 babies a year are born with oesophageal atresia and/or trache-oesophageal atresia. Oesophageal atresia occurs when the oesophagus (food pipe) fails to join up during early foetal development. Trache-oesophageal fistula describes an abnormal connection that forms between the oesophagus and trachea (wind pipe). When the baby feeds, milk cannot pass into the stomach but can pass into the lungs.
Surgery is needed within the first few days of life and is extremely successful, with 90-95% of babies surviving. However, approximately 50-80% of babies will have ongoing feeding or swallowing difficulties resulting in choking, chest infections and pneumonia. They can also lead to food refusal, distress at mealtimes and parental anxiety.
Currently we have limited understanding of:
• the exact nature of the feeding and swallowing difficulties
• the risk factors for developing difficulties
• the impact on parents.This study will address these issues through two complimentary projects:
Project 1: A study of swallow physiology
Babies with oesophageal atresia and/or trache-oesophageal fistula who have surgery at Great Ormond Street Hospital will be invited to have a detailed swallow assessment using videofluoroscopy (video x-ray) and high resolution impedance manometry (a pressure monitor) at 2-4 months of age and at 8-10 months of age. Results will be compared to parent report of feeding at 1 year old.Project 2: A study of the impact on parental well-being
This study will be carried out in conjunction with the ‘TOFS’ support group. A Facebook page will be used to carry out an online forum. Parents of any child who has had TOF/OA will be invited to share their experiences of establishing feeding. This information will be used to develop a questionnaire to look at how wide-ranging these experiences are.REC name
London - Central Research Ethics Committee
REC reference
20/LO/0098
Date of REC Opinion
6 Feb 2020
REC opinion
Favourable Opinion