FAQs for parents

There are no known risks for infants taking part in DOLFIN. All infants taking part will be monitored by their local NHS clinical team. If they need to know whether your baby is receiving the treatment or control supplement they can find out from the trial team. If your infant develops a possible allergy to cow's milk protein, egg or fish you will be asked to stop the supplement whilst this is assessed. If the supplement is effective, your infant's neurological child development (how they think, communicate, play and interact with others) may be improved.

The study is being carried out by children's NHS doctors and dieticians from Newcastle upon Tyne NHS Foundation Trust, and Newcastle University together with local NHS teams from across the UK. Newcastle upon Tyne NHS Hospitals Foundation Trust are the trial Sponsor. The trial is co-ordinated and delivered in partnership with the National Perinatal Epidemiology Unit (NPEU), University of Oxford. Parents, and the neonatal charity Bliss are part of the research team. The study has been reviewed and funded by the NHS research funder the National Institute for Health and Care Research (NIHR).

The supplement is produced, quality control checked, and shipped to the UK by Nutricia, Netherlands. Nutricia have no input into the design of the study and will only be able to see the results of the study once they are publicly available.

The supplement has been used in two smaller studies of around 100 infants. These small studies suggested that the supplement may improve neurological child development, but were too small to tell for sure. These studies did not show any problems or side effects caused by the supplement. A much larger study is needed to show whether the supplement can improve neurological child development before it could be made widely available. If the study tells us the supplement is effective, it might be given to babies as part of future NHS care.

The supplement contains nutrients that occur naturally in a healthy diet and are often used as food supplements. These nutrients are long chain polyunsaturated fatty acids, uridine-5'-monophosphate, cytidine-5'-monophosphate and choline, and vitamins and trace elements.

The control supplement is a well-balanced nutritional product which contains much smaller amounts of most, but not all, of the treatment supplement nutrients.

We do not know whether the treatment supplement is beneficial. We need to do carry out this trial to find out. You will not be able to choose whether your baby receives the treatment or control supplement. Your local NHS clinical team and staff at the NPEU trials unit will not know which supplement your infant is receiving.

We are asking for your permission to collect information about your child's progress at school-age. We may also contact you just before our child starts school to ask if you would like to take part in a further study looking at their neurological child development at that time. Taking part in this will be optional. If you would like to know which supplement your child received, we can let you know once we have the results of these long-term follow up studies. Hospital transfers and admissions

Yes. We will contact the hospital to see if they can support you whilst your infant is in that hospital. If that hospital does not have the staff to be able to support the study, your infant will have a short break from taking the supplement. We expect short breaks to happen over the 12-month supplementation period and this will not affect your participation in the trial.

Yes. You can let us know about an unplanned hospital admission on the DOLFIN App or by contacting your local NHS clinical team. They may need to speak with you to gather more information so that they can complete trial Safety Reporting procedures. DOLFIN documents

Most documents and resources are available to view and download on the DOLFIN website Resources page. You can also contact your local NHS clinical team with any questions. If you have can't find the contact details for your local NHS clinical team you can contact the DOLFIN study team dolfin@npeu.ox.ac.uk/ 01865 617919

Not yet, but these may be available in the future. Giving the supplement

Please throw away any expired supplement in your waste bin. If sachets are lost or damaged, please don't worry - just contact your local NHS clinical team or the DOLFIN study team on: dolfin@npeu.ox.ac.uk or 01865 617919. The supplement will be delivered to your home by courier, free of charge.

Babies and small children grow quickly. For this trial it is important that your child is weighed once a month to ensure they are receiving the correct amount of supplement for their weight. Your GP and Health Visitor know that your child is taking part and has been asked to help you access weighing scales. If you have missed a monthly weight, please arrange to have them weighed as soon as you can.

We expect that infants will have occasional missed doses or breaks in having their supplement over the course of 12 months. This does not mean you have to withdraw from the trial. You can use the DOLFIN App to report that the dose has been missed and the reason why. This information will help us to understand the study results.

If your infant does not finish the feed, they will not have received the full amount of supplement. You can give the amount of supplement your infant missed with a different feed later in the day. Examples of how to work out the amount of missed supplement are on page 7 of the 'Parent Information for supplement use' leaflet and available on our website.

Many infants vomit a little after a feed. This is normal. Please don't try to give more supplement to replace what could be lost due to vomiting. If you are worried about regular vomiting (whether the supplement has been added to the feed or not) please contact the clinical team or GP for advice.

If your infant is unwell and doesn't want to take his/her normal feed, you don't need to give the supplement during this time. You can re-start it when they have recovered. If you are unsure what to do, please contact your local NHS clinical team for advice.

Colic and trapped wind is extremely common in new-borns. Infants with hypoxic ischaemic encephalopathy (HIE) can be especially prone to these sorts of issues. It is very unlikely that these symptoms are related to the supplement; there was no increase in these sorts of symptoms in the smaller studies carried out before this study. If your infant is otherwise well, and symptoms only occur with feeds containing the supplement, please contact your local NHS clinical team using the contact details on page 4 of the Parent Information for Supplement Use booklet. If symptoms occur with most feeds but your infant is well, your Health Visitor or GP will be able to provide further advice. If you are concerned that your baby may be unwell, please arrange for your infant to be seen by a doctor.

There are several causes of loose watery stools. If your infant is otherwise well, please contact your local NHS clinical team for advice in the first instance. They may suggest to stop the supplement for a short while, to see if the symptoms get better. If your infant is unwell in any way please arrange for your infant to be seen by a doctor.

The supplement does not have to be given in one feed only. You can split the supplement across several feeds. Our 'Parent Information for Supplement Use' leaflet gives some examples of how to do this. You may find it helpful to look at the breastfeeding resources on the DOLFIN website. Your local NHS clinical team may also have access to infant feeding advisors who will also be able to help. If your child is weaning, you can add the supplement to food instead. The 'Parent Information for Supplement Use' leaflet also gives advice on how to add the supplement to foods with recipe suggestions.

If all you infants are taking part in the study, they will be receiving the same type of supplement so this is not a problem.

The supplement dissolves best in milk. If you are unable to mix the supplement with your infant's their usual milk, you can make up the supplement by mixing it with water, using the method for giving the supplement before a breast feed on p.18 of the 'Parent Information for Supplement Use' leaflet. The supplement may take longer to dissolve in water.

You can continue to give any prescribed medications, fortifiers and vitamins whilst taking the supplement.

If your infant is starting an exclusion diet to assess for a food allergy, you may be asked to stop the supplement whilst this happens. Please contact your local NHS clinical team for further advice.

You can stop giving the supplement or being part of the study at any time, without giving a reason. Please let your local NHS clinical team know as soon as possible. We will keep any information that we have collected already and ask you if wish to continue completing the questionnaires. We would like to continue collecting information about your child's health from central NHS records. If you do not want this to happen, tell us and we will stop. DOLFIN App

Continue to give the supplement as usual. If possible make a note of when supplement was given/not given. Check for updates in your App store. If the problem continues, please contact your local NHS clinical team or the DOLFIN team: dolfin@npeu.ox.ac.uk or on 01865 617919. You can report supplement on the app for up to 7 days after it is due, or the local NHS clinical team can input your information until the problem is resolved.

We would like to know if infants are being given the supplement or not. You can report up to 7 days previous so you could use the app once a week and report for the previous 7 days if daily reporting is too much. Reminders can easily be switched from daily to weekly (see DOLFIN Study App User Guide https://www.npeu.ox.ac.uk/dolfin/parents/resources DOLFIN questionnaires

As part of the study, you will be asked to complete questionnaires about topics like family circumstances, quality of life and how you are finding giving the supplement. These questionnaires will help us tell whether the supplement has a wider effect on families, and is acceptable. When your child is 2 years old, you will be asked to fill out a questionnaire about your child's neurological development. This questionnaire will help tell us if the supplement improves neurological child development, or not. If you are having difficulty completing the questionnaires, please contact your local NHS clinical team or the DOLFIN trial team who will be happy to help you complete them.

Please contact the DOLFIN study team on dolfin@npeu.ox.ac.uk or 01865 617919 and we will resend you the link.