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Swallowing, Feeding and Eating in Children Born With Oesophageal Atresia/Trache-oesophageal Fistula (OA/TOF)

NCT04183621 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 20

Last updated 2022-03-21

No results posted yet for this study

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 there is 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 8-12 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.

Conditions

  • Esophageal Atresia With Tracheoesophageal Fistula

Interventions

DIAGNOSTIC_TEST

high resolution impedance manometry

Two detailed swallow assessments to be carried out at between 2-4 months and 8-10 months of age

Sponsors & Collaborators

  • National Institute for Health Research, United Kingdom

    collaborator OTHER_GOV

  • Great Ormond Street Hospital for Children NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Alex Stewart · Great Ormond Street Hospital for Children, London

Eligibility

Min Age
1 Month
Max Age
4 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2023-09-30
Completion
2024-04-30

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04183621 on ClinicalTrials.gov