For parents & guardians

GASTRIC-PICU is a national research study which aims to better understand how to ensure children are getting enough calories whilst they are on a ventilator (breathing machine) and being fed through a tube.

It is a common practice in all Paediatric Intensive Care Units (PICU) for nurses to check how much food is in the stomach. A syringe is attached to the end of the feeding tube and the child’s stomach contents are gently ‘sucked out’. This is to see how much fluid is in the child’s stomach and see how well the child is digesting their feed. This is called the gastric residual volume or GRV, often referred to as an ‘aspirate’. If a child has a ‘large’ GRV, often feeding is stopped. However, the amount of fluid in the child’s stomach is affected by many things, not just how much we feed them, but also how much gastric juice their stomach produces and some of the medicines we use slow down the stomach’s actions. The measurement of this (GRV) through the NG tube or gastrostomy is known to be quite inaccurate. Therefore, a decision may be taken to stop feeds, or not to increase feeds, when there is no need to. We do not know whether it is better to measure GRV routinely or not and this is why we are doing this study.

This study is sponsored by the Intensive Care National Audit & Research Centre (ICNARC), based in the UK, and they are the people who control the data that is collected and used for the study. This study (GASTRIC-PICU) is funded by the National Institute for Health and Care Research – Health Technology Assessment Programme.  The National Institute of Health and Care Research is an organisation that gives government funding for health research and health-related technology projects. To find out more about the National Institute for Health and Care Research, please visit their website.

To help us manage and meet the objectives of the study – ICNARC collects and holds personal data about your child (and other study participants). This information (such as your child’s date of birth, NHS number, health data and your contact details) was collected by the research team at the hospital where your child became involved in the study. This information was securely submitted to ICNARC. The research team will also collect information on your child’s survival from their medical records until the end of the study.

This private information is important to us, and we want to protect it from being seen by anyone who isn’t connected with the study. One of the ways we do this is by allocating each participant a unique code number, called a ‘trial number’. This means we can track your child’s recovery, without their personal information being seen by anyone outside the team. The term used for this process is ‘pseudonymised’.

We will apply for advice from the Confidentiality Advisory Group to process personal data on participants in England and Wales for whom explicit consent was unable to be obtained. The Confidentiality Advisory Group provides expert advice to the Health Research Authority on whether applications to access confidential patient data without consent should be approved, or not, under Section 251 of the National Health Service Act 2006 and Regulation 5 of the Health Service (Control of Patient Information) Regulations 2002 (often referred to as ‘Section 251 support’). This advice will relate to:

1) Patients who were included in the trial, but for whom explicit consent was unable to be obtained from their parent or legal guardian. Explicit consent may not have been able to be obtained because the patient died or was discharged from hospital very soon after inclusion. We will process identifiable data on this relatively small cohort of patients in order to ensure that the study results are accurate, and not biased by excluding these patients records. This data will include NHS number, date of birth, sex and postcode.

Section 251 support provides a lawful basis for the processing the data (described above) without incurring a breach of the common law duty of confidentiality. If your child has a ‘national data opt-out’ in place to prevent their confidential patient information being used for research and planning, then only anonymised data will be collected, and they will not be able to be identified. If you would like to opt-out of any of the processing described in this section, then please use the contact details at the bottom of this page.

ICNARC will follow-up on your child’s well-being by requesting some important health information, including survival and hospital stay data, from national databases held by NHS Digital and Digital Health and Care Wales, formerly NHS Wales Informatics Service (organisations that manages access to national databases of NHS records) and PICANet. To obtain this important information, the GASTRIC-PICU trial team will send your child’s date of birth, home postcode, sex, NHS number and unique trial number (required to ensure they can be identified in the database correctly) to NHS Digital using a secure password protected online file exchange service. An authorised person from NHS Digital will then link the identifiers to the national records on survival and hospital stays and securely send back the relevant data for storage on the secure GASTRIC-PICU trial database. The same process will be carried out with Digital Health and Care Wales and PICANet.

We will also use the data collected by the research team at the hospital where your child became involved in the study to send a questionnaire on health and well-being 6 months after entry into the study if you agreed to this. The questionnaire will either be sent via post or email. If you opted to receive the questionnaire by email, then we will send you a link to the questionnaire using SmartSurvey. SmartSurvey’s privacy policy can be found here. We may also telephone you to check if you received the questionnaire, or send you a text message reminder using our text messaging service Janet Txt. Janet Txt’s privacy notice can be found here.

All of the information is held in a secure password protected database, with access only by authorised research team members at your hospital and at ICNARC. Information collected during GASTRIC-PICU is stored on ICNARC’s secure servers which are owned by an authorised contractor called Exponential-e. ICNARC takes steps to ensure this information is not lost and makes regular back-ups of the data. ICNARC also contract Babble Cloud who provide external desktop and network managed services, including end user and infrastructure support. Employees at Babble Cloud will not access the data, however, they do have remote access to ICNARC servers.

Once the study is finished, statisticians from ICNARC will analyse the information to find out which treatment was most effective. A member of our team based at the London School of Hygiene and Tropical Medicine will help with some of the analyses but will only have access to pseudonymised data and will not be able to identify any of the participants.

At the end of the study, ICNARC will keep the personal data about your child for no longer than one year after the study has finished. The information will be then anonymised so that your child can no longer be identified. It will not be possible to identify any person who has taken part in the study in any reports or articles.

ICNARC process data for this study under the legitimate interest legal basis. This is because ICNARC is a registered charity and the data processing described here is to support scientific and statistical research. Your rights to access, change or move your child’s information are limited, as we need to manage the information in specific ways in order for the research to be reliable and accurate. If you withdraw your child from the study, we will keep the information about your child that we have already obtained. To safeguard your child’s rights, we will use the minimum personally-identifiable information possible. There is no automated decision making or profiling.

If, when you consented for your child to be included, you indicated that you did not want us to either obtain the above information from NHS Digital/Digital Health and Care Wales or PICANet or to send you a questionnaire, then we will not process your child’s data for

these purposes. You are free to opt out if you no longer wish that we process your child’s data in these ways (contact details below).

More information about GASTRIC-PICU is available on this website. If you have any other questions or wish to opt out or withdraw, please contact:

Marzena Orzol       Trial Manager        GASTRIC@icnarc.org            0207 269 9272

ICNARC’s overarching privacy notice, and details of our Data Protection Officer, is available here.

If you have a complaint about our use of your information, you can contact the Information Commissioner’s Office via their website or write to them at:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF