About the EveryPrem Project
What is the EveryPrem Project About?
The EveryPrem Project is evaluating a new, international tool INTER-NDA to measure neurodevelopment in 2-year-old children, who were born at less than 37 weeks gestation of pregnancy, against the current developmental testing offered by the Neonatal Team at the John Radcliffe Hospital, Oxford to children. The purpose of the study is to assess the effectiveness, mediumterm patient benefits and health care costs of this new neurodevelopmental test for all children, at 2 years of age, who were born preterm (at less than 37 weeks gestation of pregnancy) at the John Radcliffe Hospital, Oxford, between April 2017 and April 2019.
Currently, because of resource issues, only those children born at less than 32 weeks are assessed to identify possible neurodevelopmental disturbances, which might lead to developmental delay and learning difficulties later in life. The test currently being used is called the Bayley scales of infant and toddler development, third edition (BSD-III).
Our study’s all-inclusive approach addresses an important unmet need for children born between 32 and 37 weeks, who do not currently receive any form of neurodevelopmental follow-up at 2 years of age, but who also are at risk of disturbed neurodevelopment as a consequence of being born preterm. Using a new, sensitive, rapid, international child developmental test INTER-NDA along with a test of vision, in this study we will assess all children born preterm for cognition, motor, language, behaviour, vision and hearing outcomes. Children whose test scores fall below the international early child development (ECD) standards will be referred to community paediatricians for enhanced care.
What will the results of the EveryPrem Project be used for?
The results of the EveryPrem project will be used to compare effectiveness and affordability of the new, international tool (INTER-NDA) against the current developmental testing (BSID-III) offered at the John Radcliffe Hospital, Oxford to a select group of two-year olds. As the new test will be examined in the context of it being offered to all children born preterm and not just the 20-30% born very early or very ill, it may be able to make recommendations regarding an extension of the developmental surveillance service to all children born preterm.
Can you tell me more about the new neurodevelopmental tool?
The new tool is called the INTERGROWTH-21st Neurodevelopment Assessment or the INTER-NDA. The INTER-NDA has been used to assess over 8000 children in 13 countries from 2012 onwards, including 600 children in Oxford, UK. The INTER-NDA involves a trained researcher carrying out a series of play-related tasks with your child; for example building a tower out of blocks, and completing a puzzle. The researcher will record her/his observations about your child’s performance on a form (this maybe a paper form or a tablet-based application). The research would also ask you a few questions about your child’s behaviour and ability to perform certain tasks at home. You can read more about the INTER-NDA here. This test takes about 15 minutes for a child to complete. It has been evaluated against the standard assessment for children born at less than 32 weeks of pregnancy (BSID-III) and has been found to be as efficient as the BSID-III in identifying neurodevelopmental disturbances in two year old children.
Our researcher will also assess your child’s vision using a series of picture cards called the Cardiff Tests. This test measures your child’s ability to see a series of picture cards as the pictures on them get (i) progressively smaller and (ii) progressively lighter. This test takes about 5 minutes. You can read more about the Cardiff Tests here.
Both tests mentioned above have been used to assess more than 600 children from two research projects (the INTERGROWTH-21st Project and the INTERBIO-21st Study) at the John Radcliffe Hospital, Oxford from 2012 to 2017. They have also been used in a number of other projects across the world carried out by our research partners. More than 8000 children across 13 countries have been assessed using the INTERNDA. Both parents and children report these assessments to be quick, interesting and an enjoyable experience.
The website INTER-NDA also mentions an assessment of child sleep and hearing. This will not be part of the EveryPrem Project.
Is participation compulsory?
No, participation in the EveryPrem Project is completely voluntary.
If you decide not to take part in this study, your and your child’s present and future medical care will not be affected in any way.
Moreover, if you do decide to participate but change your mind at a later date you can opt out of this study at any time without your medical or legal rights being affected. If you do not wish to receive any further information about the study, and/or do not wish to participate in the EveryPrem Project, please send the study team an email to firstname.lastname@example.org or unsubscribe by clicking here <link to unsubscribe page>.
What will happen to my child and I if we take part?
The study involves visiting the John Radcliffe Hospital once, preferably in the morning. After you have signed the consent form:
1. A research assistant will ask you a few questions relating to your pregnancy, your child’s birth, health, growth and feeding during the first two years of life.
2. A research assistant will undertake a few play-related tasks with your child – this would involve, for example, looking at picture cards and building a tower of cubes. This will measure your child’s vision, and neurodevelopmental outcomes such as motor, language and cognitive skills. Your child’s length, weight and head circumference will be measured.
3. A healthy snack is provided to all children in between assessments.
4. If your child was born at less than 32 weeks, they will also be assessed the BSD-III and the assessments described in point 2 above (the INTER-NDA package). If your child was born at between 32 to 37 weeks of pregnancy, they will be assessed using the INTER-NDA package (point 2) alone.
5. Either during or after the assessment you will be asked to complete a brief questionnaire about your opinions on developmental assessments in preterm children.
6. One on one in-depth interviews will be conducted for up to 20 parents who consent to take part in the in-depth interviews and who give permission for the interviews to be audio-recorded. For such parents, a £10 lunch voucher will be provided.
7. After the assessments, all children whose test scores fall below the standard level will be referred to a community paediatrician for a more advanced assessment.
8. The research team will contact you when your child is in Year 2 of school to request you to send us your child’s SAT scores.
How have I been contacted?
You have been identified by the neonatal care team at the John Radcliffe Hospital, Oxford, to be the parent/guardian/carer of a child who was born, between April 2017 and April 2019, at less than 37 weeks of pregnancy.
If your child was born at less than 32 weeks or had other risk factors, the usual neonatal care team would have contacted you anyway, at the time of your child’s second birthday, to offer you an appointment with the neonatal team for neurodevelopmental screening of your child. This would be conducted using the current standard test (called the BSID-III) for children born at less than 32 weeks of pregnancy.
If your child was born between 32 and 37 weeks, the neonatal care team have identified him/her from the medical records, therefore the request to participate in the study comes from the clinical team.
None of the researchers working on this study will have accessed you or your child’s hospital notes.
What will happen to my data?
Data protection regulation requires that we state the legal basis for processing information about you. In the case of research, this is ‘a task in the public interest.’ The University of Oxford is the data controller and is responsible for looking after your information and using it properly.
We will be using information from the National Neonatal Research Database, the JRH EPR system and NHS Spine in order to undertake this study and will use the minimum personally-identifiable information possible. We will keep identifiable information about you for less than 3 months after the study has finished. This excludes any research documents with personal information, such as consent forms, which will be held securely at the University of Oxford for 17 years after the end of the study.
The neonatal team at the John Radcliffe Hospital and the study team will use your and your child’s name, home address, and contact details to contact you about the research study. They will keep identifiable information about you from this study for less than 3 months after the study has finished.
Data protection regulation provides you with control over your personal data and how it is used. When you agree to your information being used in research, however, some of those rights may be limited in order for the research to be reliable and accurate. Further information about your rights with respect to your personal data is available here.
Are Expenses and payments made to those participating?
Reasonable travel expenses, including parking charges, for any visits additional to the routine assessment will be reimbursed on the production of travel and/or parking receipts or on the basis of a mileage allowance in accordance with the University of Oxford travel. A £10 lunch voucher will be provided to parents who will participate in the in-depth interviews. There is no payment for participating in the study. You will receive a £10 gift voucher as a thank you for completing the Year 2 SATs scores survey.
What are the possible disadvantages and risks of taking part?
The child assessment, equipment and materials themselves are safe and carry no risk. Over 8000 children in 13 countries have been assessed using the INTER-NDA, including 600 at the John Radcliffe Hospital, Oxford. Almost all parents and children have reported the tests to be quick and enjoyable. However, toddlers do, extremely rarely, become upset during assessments. In the unlikely event that your child becomes distressed for any reason then we would stop straight away.
We anticipate that a proportion of children taking part in the study may be identified as having some potential disturbances in neurodevelopment. We understand this may cause concern and distress for parents. However, we feel that it is in the best interest of the child that such potential disturbances are identified as it enables access to early referral and interventions that may mitigate the risks of problems in the future. In such cases, the child will be referred to your GP and/or community paediatrician via the Neonatal Team.
What are the possible benefits of taking part?
Taking part in this study would not usually benefit you or your child directly. The only situation where there might be direct benefit would be if we detected potential developmental problems, which might allow earlier referral of your child to doctors for further investigation and/or intervention. Taking developmental measures from your child would help us to determine what proportion of children born between 32 and 37 weeks of pregnancy, and who are not currently followed up at 2 years of age on developmental assessments, have developmental disturbances. This is important as it would help us present evidence to the Health Authorities to support an extension of the current preterm screening strategy from children born at less than 32 weeks of pregnancy to all children born at less than 37 weeks of pregnancy.
Will my taking part in the study be kept confidential?
Yes. We follow ethical and legal practice and all information and data collected are handled in complete confidence.
What will happen if I do not want to carry on with the study?
You may withdraw from the study at any time. It would not affect the current or future care you or your child receives in any way. If you decided to withdraw from the study, you may request for your and your child’s data and assessments to be removed from our database. You may also request for any stored data that identifies you or your child to be destroyed from our computer hard drives, project servers and project email inboxes according to guidelines provided by the University of Oxford. You may also request that printed materials and paper forms containing your and your child’s data be disposed of according to the University’s policy for destroying Confidential Waste.
What if there is a problem?
The University of Oxford, as Sponsor, has appropriate insurance in place in the unlikely event that you suffer any harm as a direct consequence of your participation in this study. If you wish to complain about any aspect of the way in which you have been approached or treated, or how your information is handled during the course of this study, you should contact Prof. Stephen Kennedy at email@example.com. or you may contact the University of Oxford Clinical Trials and Research Governance (CTRG) office on 01865 616480, or the head of CTRG, email firstname.lastname@example.org. You can also contact the Patient Advice and Liaison Service (PALS) on telephone number 01865 221473 or email PALS@ouh.nhs.uk. PALS is a confidential NHS service that can provide you with support for any complaints or queries you may have regarding the care you receive as an NHS patient. PALS is unable to provide information about this research study. If you remain unhappy and wish to complain formally, you may also follow the normal NHS complaints procedure. Please see: www.nhsdirect.nhs.uk/articles/article.aspx?articleId=569 for more information.
Will my taking part in this study be kept confidential?
Any information that is collected about you and your child during the course of the research will be kept strictly confidential. Our research team – Chief Investigator, CoInvestigators, Neonatal Consultant, Data Manager, Statistician and Research Assistants, who have a duty of confidentiality to you and your child as research participants, will be the only persons who will be able to identify you and your child. If you choose to participate in the study, your and your child’s data will be held deidentifiably on a secure database stored in a locked office, to which only the research team will have access. The audio recorded interviews will be transcribed by an external transcription service who will sign a confidentiality agreement with the study. All audio responses will be de-identifiably labelled, and the transcriber will not be able to identify you with your audio records. We will kindly ask for your consent to quote you directly in research outputs as may be applicable. We will ask your consent to be quoted in the study’s research outputs. However, you can decide if you wish for your quotes to be marked with your name or a pseudonym. As your views are valuable to us, all parents will have the opportunity to share their views through the parent survey even if they are unable to participate in the interview.
Authorised representatives of the University of Oxford and/or the Oxford University Hospitals NHS Foundation Trust may look at the de-identified results to ensure that the study is complying with applicable regulations. No individual participants will be identified when the results of the study are published. Any information that leaves the hospital will have all your personal identifiers removed so that you cannot be identified.
If you choose to continue with the study, your and your child’s electronic data and results will be held de-identifiably on a secure database on a secure University of Oxford server, and any hard copies will be stored in a locked office, in a securely locked cabinet, which only the research team has access to.
Study data will be retained for 17 years after the end of the study (three years after the youngest child recruited to the study reaches the age of 18 years) in the event that future discussions about outcomes in children born preterm will require so. After 17 years, the data will be disposed of securely from computer hard drives, project servers and project email inboxes according to Research Data Oxford governance, and the policies of the RDM Delivery Group, University of Oxford. Printed materials and paper forms will be disposed of according to the University’s policy for destroying Confidential Waste. You have the right to check the accuracy of data held about you and your child, and to correct any errors.
We will share your child’s anonymised data, which include reports of your child’s clinical assessment and your socio-demographic data, with academic collaborators around the world. At no point will these collaborators be able to identify or contact you or your child.
How have patients and the public been involved in this study?
The study was registered as an ‘opportunity’ in the ‘People in Research section’ of the INVOLVE website. The research proposal has been reviewed by five mothers of eight children born at 28, 32, 33, 34 and 35 weeks’ gestation reviewed by Emma Cantrell, Director of The Support for the Sick Newborn and their Parents (SSNAP) in Oxford.
What will happen to the results of the research study?
The results will be prepared for publication in scientific journals and presentation at international meetings. We can provide you with a copy of the papers after publication if you wish. Your name will not appear in any report or publication. Some of the data from the study may be included in the PhD thesis of one or more of the researchers. Your identity will be protected at all times.
Who is organising and funding the research?
The research is being carried out by the Nuffield Department of Women’s & Reproductive Health at the University of Oxford. It is being funded by a donation to the University. The doctors and researchers involved in the research are not being paid to include you in the study and have no conflicts of interest with regards to the study.
Who has reviewed the study?
The research has been reviewed by an independent group of people called a Research Ethics Committee to protect your interests, safety, rights, well being and dignity. This study has been reviewed and given a favourable opinion by the XXX Research Ethics Committee.
Participation in future research:
If you agree to your details being held to be contacted regarding future research, we will retain a copy of your consent form until such time as your details are removed from our database but will keep the consent form and your details separate. Your contact details would be held separately from this study on a password-protected computer in the Nuffield Department of Women’s and Reproductive Health, University of Oxford.
All future contacts with you will come from your research team in the first instance. Agreeing to be contacted for future research will not oblige you or your child to take part in any such future research, and your contact details can be removed from this register at any time you wish.