Age 4 – 5 visit information

BREATHING TOGETHER STUDY

PARTICIPANT INFORMATION SHEET FOR AGE 4-5 VISIT (for parent/guardian)

We are inviting your child to continue to take part in the Breathing Together study. 

Before you decide whether your child should take part it is important for you to understand why the research is being done and what it will involve.  Please take time to read this information carefully and discuss it with others if you wish.

  • Part 1 tells you the purpose of this study and what will happen to your child if they take part.
  • Part 2 gives you more detailed information about the study.

Please take your time to read this information sheet. If anything is not clear and/or you require more information before you decide whether or not to take part in the study, please contact a member of the study team (details at end of information sheet).

Part One

Asthma is one of the commonest long-term conditions in childhood and adulthood.  Many children with asthma already have problems with episodes of wheezing by the time they are two or three years old. It is therefore important for doctors to understand how lungs develop in the first few years of life. At the moment we do not understand this nor why some children start to wheeze or develop asthma. At least a third of babies will develop wheeze before they start school. We think that problems with the lining of the breathing tubes inside of the lung (the airways) and with the developing immune system are vitally important to the development of asthma.

What is the purpose?

The purpose of this study is to understand how both the lining of the lungs and the immune system develop in well pre-school children and what is different in children who develop asthma. This approach has never been studied before in children from birth. We will also assess how allergies and the bacteria in our environment affect the way that the lining of the lungs and the immune system work.  We will study the cells from the inside of newborn babies’ noses, because they are very similar to those lining the airways, and blood immune cells. We will use the information gained in this study to develop new approaches to prevent children from developing asthma.

Why has my child been invited to take part?

They have been chosen because they have been participating in the study since birth.

Do they have to take part?

It is entirely up to you as to whether you wish your child to participate in the study.  If you decide that your child will take part, you will be given a copy of this information sheet to keep and you will be asked to sign a consent form. You are free to withdraw your child from the study at any time and without having to give a reason.

What will happen to my child if they take part

  • We will collect some information about your child and their immediate family plus some samples  when they are around four to  five years of age.

What will we do?

At age three, we asked you to complete an online questionnaire about your child’s respiratory health and any allergies they may have. This is because we did not feel it was safe for your child, your family or our research nurses to carry out sample collection during the pandemic.

For the four-to-five-year assessment, we will assess your child in a similar way to the one year assessment. . A table summarizing the visit is available on page 3. The age 4-5 questionnaire is online, so you will have the option to complete it either at the visit with the research nurse or at home in your own time within a few days of the visit. For those children who have been diagnosed with asthma, there will be some extra questions about their asthma control. We also like to collect your current postcode in order to apply the most recent UK air pollution model to our research.

We would additionally do:

Allergy skin testing – this is a test we commonly do in clinic which involves dropping some solutions on their arm and scratching them with positive test coming up as a bump.

We are asking to collect a sample of saliva from your child, so that we may look for genes in your child’s DNA that seem to be related to childhood wheeze. Some of the work we have done in related studies suggests that there are certain genes related to wheeze and asthma in children. By looking at these genes in the 1,000 children who joined this study at birth (including your child), we can check to see if these are really important to wheeze and asthma. Additionally, we hope to use the cells we collect from your child’s nose to see how airway cells work when these genes are expressed differently (usually by turning the genes “on” or “off”). This is something that no other study we are aware of has been able to do before.

If your child can spit or dribble, they can do this directly into a sample pot; in other cases, the research nurse can hold a small sponge in your child’s mouth to absorb the saliva.

We would also like to assess your child’s lung capacity, or function at the age 4-5 visit. This is called a spirometry test. It is a simple blowing test that requires your child to take a breath in and then blow out as hard and as fast as they can into a machine to test their lungs.  We might ask them to repeat this a few times. At age 3, most children are not quite able to pick up the breathing technique required. However, by age 4, more children are able to better understand the technique and this assessment will give us valuable information. Not all the children will be able to complete the lung function and that is okay, it’s nothing to worry about.

If your research nurse has any concerns about your child’s lung function at the time of the test, they will contact the local Consultant principal investigator for the study for advice.

Finally, we want to collect some general health measures, namely your child’s height, weight, waist circumference and blood pressure to assess your child’s wellbeing. We will calculate your child’s body mass index from height and weight.

Only some children who start to wheeze in their first few years of life develop asthma. In the future, we hope to follow up children in this study to find out whether or not they developed asthma, other breathing problems or any allergies. This might be by contacting your general practitioner, a telephone/postal/online questionnaire or a clinic visit.

This study does not involve thetesting of any new medication.

The table below provides a summary of the Age 4-5 visit.

Sample/TestHow is it done?What does it tell us?
QuestionnaireCan be completed during the visit or at homeRespiratory history, environmental factors (eg pets, school,) that may affect respiratory health
Nasal brushingWe will brush one nostril to collect nasal airway cellsWhat “messages” the airway cells are sending
Nasal swabWe will swab inside one nostril to collect some of the snotWhich microbes are living in our noses
Throat swabWe will swab the back of the throat to collect some secretionsWhich microbes are living in our throats
BloodWe will prick the finger, the same way a diabetic person does to check blood sugar, and collect a droplet of bloodWhat “messages” our immune system is sending
SalivaYour child can dribble a bit of saliva into a small bottleWhich gene might be related to wheeze & asthma
Allergy skin prick testingSolutions containing common allergens will be dropped onto the skin and the skin will be lightly scratched through the dropHow  immune system responds to allergens that we often breathe in
Lung functionYour child will take a deep breath and then breathe out as hard and fast as they can into a machineLung capacity and function
Metabolic measurementsHeight, weight, body fat percentage, waist circumference and blood pressure will be checkedGeneral health and well-being

What are the benefits of taking part?

There may be no benefits to your child taking part. However, if they develop wheeze or we find that the allergy tests are positive, we will be able to provide you with additional advice.  We will also contact you at the end of the study with a summary of the study results. 

Travel and parking expenses will be reimbursed where appropriate.

What are the possible disadvantages and risks of taking part?

We do not think that there will be any risks to your child in taking part. They may experience a little discomfort with the nasal brushing and blood samples.

What if something goes wrong?

Imperial College London holds insurance policies which apply to this study. If you experience harm or injury as a result of taking part in this study, you will be eligible to claim compensation without having to prove that Imperial College is at fault. This does not affect your legal rights to seek compensation.

If you are harmed due to someone’s negligence, then you may have grounds for a legal action. Regardless of this, if you wish to complain, or have any concerns about any aspect of the way you have been treated during the course of this study then you should immediately inform the Investigator (Insert name and contact details). The normal National Health Service mechanisms are also available to you. If you are still not satisfied with the response, you may contact the Imperial College, Research Governance and Integrity Team.

This completes Part 1 of the Information Sheet. Part 2 will give you more detailed information about the conduct of the study.

Part 2

HOW WILL WE USE INFORMATION ABOUT YOU? 

Research Study Title: Breathing Together study

IRAS 199053

Imperial College London is the sponsor for this study and will act as the data controller for this study. This means that we are responsible for looking after your information and using it properly. Imperial College London will keep your personal data for:

  • 20 years after the study has finished in relation to data subject consent forms.
  • 20 years after the study has completed in relation to primary research data.

We will need to use information from you, your child, and your child’s medical records for this research project. 

This information will include your:

  • Name
  • Contact details (phone number, email  and postal address)
  • Child’s name
  • Child’s NHS number

People will use this information to do the research or to check your records to make sure that the research is being done properly.

People who do not need to know who you are will not be able to see your name or contact details. Your data will have a code number instead. 

We will keep all information about you safe and secure. 

Your child’s date of birth will be sent to Australia. They must follow our rules about keeping your information safe. 

Once we have finished the study, we will keep some of the data so we can check the results. We will write our reports in a way that no-one can work out that you took part in the study.

LEGAL BASIS

As a university we use personally-identifiable information to conduct research to improve health, care and services. As a publicly-funded organisation, we have to ensure that it is in the public interest when we use personally-identifiable information from people who have agreed to take part in research.  This means that when you agree to take part in a research study, we will use your data in the ways needed to conduct and analyse the research study.

Health and care research should serve the public interest, which means that we have to demonstrate that our research serves the interests of society as a whole. We do this by following the UK Policy Framework for Health and Social Care Research

INTERNATIONAL TRANSFERS

There may be a requirement to transfer information to countries outside the European Economic Area (for example, to a research partner). Where this information contains your personal data, Imperial College London will ensure that it is transferred in accordance with data protection legislation. If the data is transferred to a country which is not subject to a European Commission (EC) adequacy decision in respect of its data protection standards, Imperial College London will enter into a data sharing agreement with the recipient organisation that incorporates EC approved standard contractual clauses that safeguard how your personal data is processed.

SHARING YOUR INFORMATION WITH OTHERS 

For the purposes referred to in this privacy notice and relying on the bases for processing as set out above, we will share your personal data with certain third parties.

Other College employees, agents, contractors and service providers (for example, suppliers of printing and mailing services, email communication services or web services, or suppliers who help us carry out any of the activities described above). Our third party service providers are required to enter into data processing agreements with us. We only permit them to process your personal data for specified purposes and in accordance with our policies.

Snap Surveys – we use Snap Surveys to send questionniares to your email address

Qualtrics – we use Qualtrics software to send questionnaires to your email address and/or phone number

WHAT ARE YOUR CHOICES ABOUT HOW YOUR INFORMATION IS USED?

You can stop being part of the study at any time, without giving a reason, but we will keep information about you that we already have. If you choose to stop taking part in the study, we would like to continue collecting information about your child’s health from [your child’s GP] If you do not want this to happen, tell us and we will stop.

We need to manage your records in specific ways for the research to be reliable. This means that we won’t be able to let you see or change the data we hold about you. 

If you agree to take part in this study, you will have the option to take part in future research using your data saved from this study.

WHERE CAN YOU FIND OUT MORE ABOUT HOW YOUR INFORMATION IS USED

You can find out more about how we use your information 

at www.hra.nhs.uk/information-about-patients/

by asking one of the research team

by sending an email to [email], or 

by ringing us on [phone number]. 

Visiting http://breathingtogether.co.uk/

COMPLAINT

If you wish to raise a complaint on how we have handled your personal data, please contact Imperial College London’s Data Protection Officer via email at dpo@imperial.ac.uk, via telephone on 020 7594 3502 and/or via post at Imperial College London, Data Protection Officer, Faculty Building Level 4, London SW7 2AZ.

If you are not satisfied with our response or believe we are processing your personal data in a way that is not lawful you can complain to the Information Commissioner’s Office (ICO). The ICO does recommend that you seek to resolve matters with the data controller (us) first before involving the regulator.

What will happen to the results of the research study?

The results will be used to help doctors to understand how the lungs develop in the first few years of life and what happens to cause some children to develop asthma. The information will be presented in a clinical study report, which may be used for publication and presentation at scientific meetings.  Your child will not be identifiable in any publications arising from this project.

Who is organising and funding the research?

The study is being funded by the Wellcome Trust and is sponsored by Imperial College London.

Who has reviewed the study?

This study was supported by the London – City and East Research Ethics Committee.

How long do I have to decide whether my child should take part?

Your decision to participate in this study is entirely voluntary. You should take as much time as you need to decide whether your child will take part.

Thank you for taking the time to read this information sheet.

Local Contacts:

East London (Barts Health NHS Trust):

Principal Investigator: Professor Johnathan Grigg

Nurse: Mumtaz Idris 

Email: mumtaz.idris1@nhs.net

Mobile: 07500809485

Edinburgh (NHS Lothian):

Principal Investigator: Professor Jurgen Schwarze

Research Nurses: Naomi Smith and Naomi Matos

Email: rhsc.crfbookings@nhslothian.scot.nhs.uk (Please say your child is taking part in the Breathing Together study and leave a contact number. The research team will ring you back to get your child’s name)

Isle of Wight NHS Trust:

Principal Investigator: Professor Graham Roberts

Research Nurses: Maria Larsson or Isle of Wight Research team

Email: iownt.Study.IOW@nhs.net

Mobile number: 07710 229794

Phone: 01983-560786

Aberdeen (NHS Grampian):

Principal Investigator: Professor Steve Turner

Research Nurses: Maggie Connon and Catriona Ward

Email:

Mobile number:

South/West London:

Principal Investigator: Professor Sejal Saglani

Research Nurse: Melanie Munn

Email: breathing.study@imperial.ac.uk

Mobile number:

Other contacts:

Project Manager: Dr Mindy Gore, Imperial College London, Exhibition Road, London, SW7 2AZ. Phone: 0207 594 6857

Chief Investigator: Prof Andrew Bush, Imperial College, London, 0207-351-8232