A Mixed Methods Exploration of Early Feeding in Children Born With Oesophageal Atresia/Trache-oesophageal Fistula.
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Functional oral intake scale
研究概览
简要总结
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.
详细描述
This study is made up of two standalone projects (described as work packages), the results of which will be combined to describe feeding and swallowing difficulties seen in children born with OA/TOF.
Work package one: Prospective cohort study This study will follow a group of children (a cohort) born with OA/TOF through their first year of life. At Great Ormond Street Hospital all children with OA/TOF have swallow assessments but not all have the same assessments at the same time. Therefore, using information from hospital records is not a reliable or useful way of learning about swallowing in this group. Children taking part in the cohort study will have two assessments; one at 2-4 months and one at 8-10 months of age. They will be followed up when they are 12 months old to see what and how they are eating and drinking. This will provide detailed information about how swallowing works and how it relates to what a child eats and drinks.
Although the planned cohort is small, the data collected will be the first of its kind. The investigators will use a new type of swallow assessment, called high resolution impedance manometry (HRIM). The study will also allow us to explore how useful and feasible this test is. Results of this study can be used to help design future, larger studies of swallowing in TOF/OA.
What will participating involve? For each swallow assessment children will have a half day hospital visit. The assessment will involve our current 'gold standard' test called a videofluoroscopy/barium swallow and the new test, HRIM. There will be a telephone review at one year of age.
High resolution impedance manometry will compare the swallowing of the OA/TOF cohort with data that has already been collected from children with 'normal' swallowing. This will give new information about:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Month 至 4 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Functional oral intake scale
时间窗: Collected at 1 year of age
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.
次要结局
- Length in centimeters(collected at 3 assessment points: 2-4 months, 8-10 months and 1 year of age)
- Food texture analysis using International Dysphagia Diet Standardisation Initiative descriptors.(1 year of age)
- Rate of respiratory infection(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)
- Rate of hospital readmission(collected at 3 assessment points: 2-4 months, 8-10 months and 1 year of age)