Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT04183621 |
| Other study ID # |
18DS08 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 15, 2020 |
| Est. completion date |
April 2024 |
Study information
| Verified date |
March 2022 |
| Source |
Great Ormond Street Hospital for Children NHS Foundation Trust |
| Contact |
Vanshree Patel, Dr |
| Phone |
020 7905 42271 |
| Email |
vanshree.patel[@]gosh.nhs.uk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
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:
- Differences in swallow muscle pressures.
- Differences in the coordination of muscle movements.
- How these differences effect the movement of food and fluid through the throat and food
pipe.
HRIM will be carried out alongside a videofluoroscopy/barium swallow. Videofluoroscopy/barium
swallow is the most commonly used swallow assessment in children. It will be used to:
- Assess the timing and coordination of swallowing.
- Identify any anatomical differences that may be causing swallowing difficulties.
- Give information from our current 'gold standard' swallow assessment to compare with the
new information available from HRIM. This will help us understand whether both
assessments are needed in the future.
No previous research has investigated whether swallowing changes over time in children born
with OA/TOF. By carrying out assessments at 2-4 months and 8-10 months the investigators
will:
- Be able to assess milk drinking and weaning foods.
- Investigate whether swallow pressures change over time.
- Determine whether it is important to assess children more than once. The final part of
this study will involve the family completing a food diary at home for three days when
their child is one year old.
- This is a simple paper diary on which the parent notes what their child eats and drinks,
how long the meal took and whether they had any difficulties.
- For example, breakfast: 1 weetabix with mashed banana and milk, ½ cup of water, took 25
mins. Ate easily.
- The food diary is returned by post or through the MyGOSH app (parent portal of the
hospital notes system) to the research team.
Once completed a telephone call will be used to:
- Clarify the food diary entries to ensure they are understood by the research team.
- Get the most recent weight and height.
- Ask whether the child has had any chest infections since the last assessment.
- Ask whether the child has been admitted to hospital since the last assessment. The
telephone call is expected to take up to 15-30 minutes. If the parent is in agreement,
results of all the assessments will be shared with the appropriate hospital and
community healthcare teams to inform clinical care and optimise the support given around
eating and drinking.
Analysis of the swallow assessments Videofluoroscopy data will be analysed using a protocol
that has been used in previous research (McGrattan et al, 2018; McGrattan et al, 2019). It
involves detailed analysis of 11 components of the child's swallow. High resolution impedance
manometry data will be analysed using online software called 'swallow gateway'. The data are
uploaded anonymously. The software is free to use. This will provide information on 17
components of the upper part of the swallow (mouth and throat) and 14 components of the lower
part of the swallow (food pipe).
All the swallowing data will be summarised using averages, counts and percentages. Given the
number of children in the study the investigators will not carry out statistical analysis
that would infer the results are applicable to all children with OA/TOF.
Work package two: a mixed methods study of parent experience This study will investigate the
impact that establishing feeding has on parents. The first part of the study will use an
online forum (via Facebook) to understand the issues parents face when they are helping their
child learn to feed. This will include breast or bottle feeding, moving on to pureed or
weaning foods and then moving on to family foods. The information gained from the forum will
be used to design a questionnaire. The questionnaire will give a deeper understanding of how
common these issues are, whether there are factors that make the impact on parents more or
less significant and whether there are time points that are particularly challenging.
The online forum
In recent years online social networks have become increasingly important sources of support
for parents of children with and without health needs. They provide a quick and easy means of
asking questions and sharing opinions and ideas. Previous research has found that carrying
out an online forum is a successful way of understanding parents experiences (Wray et al,
2018). It is good for parents of children with health needs for a number of reasons:
- Parents can participate at a time and in a place convenient to them.
- Participants do not have to answer every question. Therefore, parents can give as much
or as little time as they wish or are able.
- Parents do not have to travel anywhere to take part. This means that people in
geographically remote places can participate.
- Parents do not need additional childcare to take part.
- It is a familiar format. Many parents are used to asking or responding to questions in
this way. Previous research has found participants find an online forum a comfortable
place to share information.
- Participants to influence the direction of discussion, arguably ensuring that the issues
explored are those most important to those taking part, reducing the risk of researcher
bias.
The online forum will be conducted using a method described by Wray et al (2018). It will be
carried out in conjunction with the 'TOFS', the UK support group for OA/TOF via their
existing Facebook page. A separate 'closed' group will be created specifically for the
purposes of the research project. The forum will be moderated by the 'TOFS' administration
team for an agreed fee of £750. This administrator will be responsible for all day-to-day
running and moderation of the forum in line with a standard operating procedure developed in
collaboration with the research team. This will include processes for managing inappropriate
or offensive messaging and distressed users as well as procedures for running the forum.
Questions and a probing guide will be generated from available literature, topics raised by
public involvement activities and with the study steering group, comprising three parents, a
Dietitian, a Speech and Language Therapist, a Surgeon and a specialist Nurse.
Questions will be put to the forum one at a time with the order and probing determined by the
responses received.
Data analysis Each week a full transcript will be sent by the forum moderator to the research
team. They will ensure the responses are anonymous by replacing names with a study number.
Once the forum is complete the data will be analysed using a process called thematic
analysis. This involves:
1. Data familiarisation: identification of interesting or significant points
2. Data coding: a summary of the point being made
3. Integration of similar codes into categories
4. Integration of categories into over-arching themes
5. Consensus discussion to reach agreed themes This process will be conducted by three
members of the research team and a parent representative to ensure the influence of
researcher bias is minimised. These themes will be used to develop a questionnaire to
explore the prevalence of the issues raised.
The questionnaire A questionnaire will be developed from the themes identified in the online
forum to understand how common these issues are in parents of children aged 0-5 years and
whether there are critical time points. It will target a larger number of parents than the
online forum. Questionnaire development requires results from the online forum, therefore an
amendment will be submitted in the future for approval.
The investigators aim to use questionnaires that capture the themes within the online forum
that have already been developed and validated. For example, questionnaires about parental
anxiety or mealtime behaviours. The project steering group will review the possible
questionnaires. Discussion of relevance and importance will be combined with ease of
completion to inform final questionnaire selection. In the absence of a suitable
questionnaire to capture an important theme, specific questions will be developed. The
questionnaires will be piloted to make sure they are readable, not too lengthy and as easy to
complete as possible. Following advice from parents questionnaires will be online and mobile
optimised. A paper version will be made available if needed.
Information regarding the child's age, medical conditions, feeding method (oral or tube),
household members and access to formal and informal support services accessed will be
collected. Names will not be collected.
How will the information be analysed? Analysis will be finalised once the questionnaires are
selected. Statistical analysis to understand the importance of a child's age, diagnosis and
access to support is expected.
