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LEAP Study FAQ
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- Who can take part in the LEAP Study?
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All clinical research studies have their own individual criteria for enrolment onto the study. The basic criteria for the LEAP Study are:
- 4-10 months of age (inclusive)
- Presence of eczema, egg allergy or both
If a child meets these 2 requirements further questions will be asked by members of the study team. The doctor/nurse will also ask about their health, medical history and any medications currently being taken. A detailed list of eligibility criteria can be found here.
- What are the parental responsibilities for this study?
- The greatest responsibility for parents/ guardians is to help ensure that their child carries out the required intervention throughout the 5 years of the study. This means helping their child either avoid peanut or regularly eat the peanut-containing snack, depending on the group to which their child is randomised. The study dietitians will work closely with the parents to help them with this.
- How will parents/guardians know what to expect in the study?
- Parents/guardians are given a patient information sheet that details all aspects of the study, including the duration of the study and visit schedules where their child’s health will be monitored. Before agreeing for their child to participate, a member of the study team will explain the study and answer any questions they may have. Regulations require that parents/guardians sign a written agreement known as an ‘informed consent form’ to enable their child to take part. This records that the parent/guardian has been fully informed of the nature of the clinical study and that they are willing for their child to participate.
- What type of care will participants receive during this clinical study?
- The clinical study team consists of a group of paediatric allergy specialists including doctors, nurses, dietitians and other healthcare professionals, all of who are committed to the health and well-being of the children involved. They will check the health of each child at the beginning of the study, provide clear instructions to parents/guardians about what participation involves and carefully monitor the health of each child throughout the study. Children in the group receiving peanuts will be given their first peanut-based snack in hospital under strictly supervised conditions to ensure safety. The study will take place over a five-year period in which the clinical study team will work together with the child’s regular care provider to help manage the child’s eczema and other allergies they may have.
- How are children protected during such a study?
- An independent ethics committee has already reviewed and approved the study in line with regulations set up to protect the public. This committee can be made up of doctors, nurses, and people from the community, who check that the rights and safety of study participants are protected. The clinical study team are a group of health care experts who are regulated by their own professional bodies and they will continuously monitor your child’s health and well-being throughout the study.
- What is the peanut-containing snack being given to children?
- Children cannot be given whole peanuts at this age as there is a danger of choking. Children randomised to the peanut group will be given a variety of peanut-containing snacks that are routinely eaten by young children in different parts of the world. One snack will be a corn crisp made of peanut butter which is easy for babies to pick up, melts on the tongue and is very easy to swallow. Other peanut-containing foods will include peanut butter, peanut butter in mashed banana and peanut soup.
- Will it cost anything to participate?
- Other than time, your participation will be at no extra cost to yourself. The peanut containing snacks known as "Bamba" will be provided at no cost to you and dietetic counselling will be provided as part of the study. The study sponsors will reimburse you for expenses you incur in travelling to and from the hospital for study visits (ie. transport costs, parking, etc.)
- Will I be paid for my participation?
- While there are many benefits to participating in the LEAP Study, we believe that payment for participation in a clinical research study involving children could be viewed as ethically questionable. Therefore, no form of payment will be provided, except for compensation for expenses involved (as described above).
- Are there any risks to my child in participating?
- Currently approximately 1 in 70 children in the UK develop peanut allergy. There is a small theoretical possibility that either intervention – be it complete avoidance or introduction of peanut – could potentially increase the rate of peanut allergy. In order to guard against this possibility your child will be monitored closely and appropriate investigations or actions taken. An independent safety committee of experts will also be monitoring the study closely in order to detect any such increased rates of allergy in either group. Children in the avoidance group will share the same risk of developing peanut allergy as other children in the UK who are not enrolled in the study. Additional, although unlikely risks, include worsening of eczema, excessive weight loss or gain, and/or metabolic abnormalities e.g. increased salt intake. The study team will closely monitor your child during the study in order to prevent and detect any such changes, and will advise on ways to immediately correct any possible problems that may arise.
- What are the possible benefits of my child taking part?
- Ultimately we hope that all the treatments in this study will help your child, however there is no guarantee that your child will not develop peanut allergy if they participate in the study. We hope that the information we get from this study will help us to prevent the development of peanut allergy in more children. In the same way, as if they did not take part in the trial, any child who develops peanut allergy during the trial will be offered appropriate testing to confirm or refute the diagnosis. Usual follow up care with specialist doctors, nurses and dieticians will also be offered.
- Couldn't my child have an allergic reaction the first time he/she eats peanuts?
- There is potential that your child could have a peanut allergy that is undetected by allergy testing and could therefore have an allergic reaction following their first exposure to peanut. This is a concern whether or not a child participates in the LEAP Study. However, children enrolled in the LEAP Study who are assigned to the "consumption group" will experience their first feeding of peanuts under the medical care and supervision of LEAP Study specialists at Evelina Children's Hospital. The highly trained, experienced medical team will carefully observe your child to ensure that medical intervention is immediate following signs of an allergic response.
- What happens when the research is completed?
- Once the trial is completed you will be aware of your child’s allergic status. If they have no allergies then they will not need any further intervention. Those participants who may have developed peanut allergy or who have other allergic disorders will be given advice and follow up appointments in an appropriate clinic (as for children who have not taken part in the study).
- Will my child’s taking part in the study be kept confidential?
- All information which is collected about you and your child during the course of the research will be kept strictly confidential. Any information which leaves the hospital will have your/your child’s name and address removed so that you cannot be recognised from it. Research folders will be labelled as confidential and kept in a locked office at all times. Access to these folders will be restricted to study investigators, study statisticians, and appointed audit authorities. The National Institute of Allergy and Infectious Diseases (NIAID), the NIAID Data Safety Monitoring Board and the Food and Drug Agency in the US may also review the records for regulatory purposes. The contractors of the NIAID will assist in the conduct and the monitoring of the research. Any information that is stored electronically will be kept ‘locked’ by password access. With your consent your GP will be informed that your child is taking part in the study and of any diagnoses (e.g. asthma or eczema) that may be made during the study.
- What will happen to the results of the study?
- During the study a newsletter will be posted or emailed to all participants informing them of the study progress. Once the study is completed the information will be audited and then submitted for publication to a peer reviewed scientific journal. Once again all the study findings will be made available to participants in a lay person format.
- What if I change my mind about my child’s involvement once the study has begun?
- Parents/guardians are under no obligation to keep their child in the study and may freely decline their child’s participation or withdraw from the study at any time, even after they have signed the informed consent form. The rights of the child and the parents/guardians are a highly important consideration in every clinical study and parents/guardians are encouraged to ask the study team any questions they may have during the study.
- Who is organising and funding the research?
- The study is being run by Professor Gideon Lack and his team of researchers based at Evelina Children's Hospital at St Thomas’ Hospital. The Immune Tolerance Network (ITN) based in the US is collaborating with Professor Lack to conduct and supervise the research study. The National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health in the US will be sponsoring the research.
- Who oversees the ethical conduct of the study?
- The study has been reviewed and approved by the St Mary’s Research Ethics Committee in the UK, the Immune Tolerance Network, NIAID and the NIAID Data and Safety Monitoring Board (an independent review board in the US). These bodies will be monitoring the study for safety and ethics purposes throughout the entire 5 year study period.
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In this Section:
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Leap Study FAQ |
| For download: |
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Printable LEAP Study FAQ |
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Printable Peanut Allerg FAQ |
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