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

NCT04183621 | Unknown

• 1 other identifier: 18DS08
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

deglutition

Outcome Measures

Primary Outcomes (1)

• Functional oral intake scale

  The functional oral intake scale is a 7 point ordinal scale of eating/drinking status. 1 indicates full non-oral feeding i.e. worst outcome and 7 indicates normal oral intake i.e. best outcome.

  Collected at 1 year of age

Secondary Outcomes (5)

• Food texture analysis using International Dysphagia Diet Standardisation Initiative descriptors.

  1 year of age

• Rate of hospital readmission

  collected at 3 assessment points: 2-4 months, 8-10 months and 1 year of age

• Weight in kilograms

  collected at 3 assessment points: 2-4 months, 8-10 months and 1 year of age

• Length in centimeters

  collected at 3 assessment points: 2-4 months, 8-10 months and 1 year of age

• Rate of respiratory infection

  collected at 3 assessment points: 2-4 months, 8-10 months and 1 year of age

Interventions

high resolution impedance manometry DIAGNOSTIC_TEST

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

Also known as: videofluoroscopy swallow study

Eligibility Criteria

• Age: 1 Month - 4 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Babies undergoing primary repair of OA/TOF and are under the care of a GOSH Consultant will be invited to participate. Approximately 90% of children have both OA and TOF. Participants will have undergone primary surgical repair and commenced oral feeding before they are 4 months of age. Participants may have OA/TOF as part of a syndromic diagnosis, such as CHARGE syndrome or VACTERL association. Children with non-syndromic OA/TOF may have comorbidities, most commonly cardiac abnormalities.

You may qualify if:

• Diagnosis of OA and/or TOF
• Consent obtained from an adult with parental responsibility
• Under 5 months of age
• Undergone surgical repair
• Orally feeding at least 30mls at any one time
• Under the care of a Great Ormond Street Hospital Consultant

You may not qualify if:

• Unrepaired OA and/or TOF
• Repair requiring gastric transposition/jejunal transposition or other non-primary repair
• Fully tube fed
• Requiring non-invasive ventilation
• Under a child protection order

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (1)

Great Ormond Street Hospital for Children

London, WC1N 3JH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Esophageal atresia with or without tracheoesophageal fistula

Study Officials

• Alex Stewart

  Great Ormond Street Hospital for Children, London

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vanshree Patel, Dr

CONTACT

020 7905 42271; vanshree.patel@gosh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2019
• First Posted: December 3, 2019
• Study Start: December 15, 2020
• Primary Completion: September 1, 2023
• Study Completion: April 1, 2024
• Last Updated: March 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)