Parents Section

Welcome to our Parents Section! Thank you to all parents who have kindly allowed their babies to participate in PREVAIL.

Your baby is contributing to research that aims to improve outcomes for early, poorly or small babies.

Quick Links for Parents:

 

PREVAIL Summary

Many babies on neonatal units need to be given fluids and medicines through their veins. Usually this is given through a tube in the arms or legs called a peripherally inserted central catheter (PICC). A PICC can also be called a ‘long line’.

In most hospitals a standard PICC is used and this can sometimes cause infections, however a different PICC coated with antibiotics and antifungal is also available and this may help prevent infections by killing bacteria. We want to see which PICC is better at reducing the risk of infection or if there are any differences between them. This information will help doctors and nurses understand how best to help babies who might be at risk of infection.

Babies who take part in the trial will be given either the standard PICC or the antimicrobial PICC. Which one they get will be decided at random by a computer and each baby has an equal chance of getting either PICC. This process is called randomisation.

We intend to follow babies who take part until six months after they are randomised. Most of the information we need will be collected by nurses and doctors while babies who take part are still in hospital. For more details about the information we collect please click here.

To see how babies do in the long term we also plan to do a follow up study, linking information from babies who took part in this study with information which is regularly collected by the NHS and the education records of when the baby reached school age. Parents can choose whether or not to give us permission to see their child's records and if they want us to contact them in the future about this research or other work.

 

How PREVAIL uses your baby's data

Details that could identify your baby, such as their name or NHS number, will be removed from the data that is collected and used for the analysis. This means that the people analysing the data will not be able to identify your baby. We will use information collected by the trial while your baby is in hospital and combine it with information about your baby’s health care.  This information is routinely collected by hospitals and laboratories during the 6 months after your baby entered the trial. This includes:
  • Information that hospitals routinely collect about hospital visits or stays

    • This is sent to NHS Digital and will tell us about any hospital visits or stays from the time your baby left the Neonatal Unit up to the end of follow-up (6 months).

  • Information routinely collected by Neonatal Units (NICUs and SCBUs - Special Care Baby Units) and Paediatric Intensive Care Units (PICUs) that treated your baby

    • This information comes from two databases called The National Neonatal Research Database (NNRD) and the Paediatric Intensive Care Audit Network (PICANet)

    • Like the NHS Digital information this will tell us about stays in NICUs or PICUs by your baby

  • Information if your baby sadly died within 6 months of taking part in the trial

    • This information would be their date of death which would be provided by NHS Digital.

    • Bliss, a charity supporting parents of babies born premature or sick, has a helpline and information for bereaved parents that you might find helpful - www.bliss.org.uk/bereavement

  • Information about blood infections that Public Health England routinely collect from hospital laboratories

    • The trial forms completed by doctors and nurses will tell us if your baby had an infection in their blood while they were taking part in the trial (the period of time that they had their PICC line in). We will use this extra information from Public Health England to see if your baby had an infection after their trial line was removed, at any time until 6 months after they entered the trial. This helps us to know how the PICC lines might affect blood infections in the longer term.

 

Who has access to my baby’s data?

PREVAIL is organised by University College London, and the day to day running of the trial is done by the Clinical Trials Research Centre (CTRC) at the University of Liverpool. All information collected about your baby while they were taking part in PREVAIL is stored securely at the CTRC, and all information collected about your baby is confidential. Information that could identify your baby will only be shared with the named organisations providing linked data in support of the study. All other data collected about your baby will only be viewed by people working on the study or working to ensure the study is run correctly. All trial data will be handled, stored and destroyed in accordance with the Data Protection Act 1998.

The University of Liverpool will use the information collected about your baby while they were taking part in PREVAIL to see if there is a difference between the standard long lines used for babies in Neonatal Care and a very similar the long line impregnated with medicines. This is the clinical effectiveness analysis.

There will also be a cost-effectiveness analysis, to know if either of the long lines is more cost-effective than the other. The University of York will do the cost-effectiveness analysis. To do this, the University of York will use the information about your baby held in routine records and the information collected during the PREVAIL trial. The University of York will calculate the cost of the hospital stay and see if there is any difference in health benefits between the two lines.

The University of Liverpool will send a copy of the information collected in the trial to the University of York. The University of York will receive a copy of your baby’s routine records about your baby’s hospital stays or visits, and date of death if your baby sadly died within 6 months of taking part in the trial. This information will be kept confidential and will not contain information that could identify your baby, such as their name or NHS number.  

There are several steps needed to gather the information for this part of PREVAIL; these are described below.

The University of Liverpool will send your baby’s information (NHS number, date of birth, postcode) and their Trial ID (the number they were given as part of the trial) to NHS Digital so that they can identify your baby’s routinely collected data. NHS Digital will obtain your baby’s routine records from the date of entry into the trial to 6 months after. NHS Digital will remove the NHS number, date of birth and postcode but keep the Trial ID. NHS Digital will send your baby’s routine records to The University of York with only the Trial IDs included.

The University of Liverpool and University of York will also request data from the National Neonatal Research Database (NNRD) and the Paediatric Intensive Care Audit Network (PICANet) (see “How PREVAIL uses your baby’s data” for more information).

As above, the University of Liverpool will send your baby’s personal information and their Trial ID to NNRD and PICANet so that they can identify your baby’s routinely collected data. NNRD and PICANet will send this information back to the University of Liverpool who will remove your baby’s personal information, so that your baby cannot be identified by the researchers conducting the analysis. The data that will be sent to the University of York will therefore not contain any of your baby's identifiable information, so nobody at the University of York will know who your baby is when they are looking at the data.

At the end of the study the data will be stored for up to 15 years (“archived”). This allows for authorised bodies such as the Medicines and Healthcare products Regulatory Agency (MHRA) to inspect the trial data to make sure it was run correctly. At the end of this time, the data will be destroyed safely in accordance with the Data Protection Act 1998 (or equivelent leglislation at the time of destruction).

 

What if I have changed my mind about my baby taking part in PREVAIL?

In consenting to the trial, participants are consented to the trial intervention, follow-up and data collection. This means you have given your consent for your baby to take part in the trial and for the doctors and nurses looking after your baby to collect information about their treatment and how they are doing on forms used only for the trial.

You have also given your consent for information routinely collected by hospitals and laboratories to be used as part of the trial analysis. For more information on how PREVAIL uses your baby’s data please click here.

If you wish to stop your baby being involved in the trial this is called withdrawing from the trial. A decision to leave the study at any time will not affect the standard of care your baby receives. Withdrawing is a different process depending on the stage your baby is at in the trial.

 Withdrawing your baby before their PICC line is inserted

If your baby is still in hospital and you have given consent to take part in the trial but have since changed your mind, you are free to withdraw consent from the entire trial at any time prior to PICC insertion without providing a reason. Your baby will likely still require a PICC line as part of their normal care but this will be a standard PICC line and no data about your baby would be collected.

 Withdrawing your baby once their PICC line has been inserted

Once the PICC line has been inserted it will only be removed when clinically indicated. Clinically indicated removal reasons include:

·    Your baby no longer needs their PICC line

·    Your baby’s doctors are concerned that your baby’s PICC line may be causing problems such as an infection or a blood clot inside the line

·    Your baby has accidentally moved their PICC line into an unsuitable position, or pulled it out entirely

 If you wish to withdraw your baby from the trial once the PICC has been inserted you are free to withdraw consent for follow-up and data collection at any time without providing a reason, even though the PICC line will not be removed immediately. When withdrawn, your baby will receive appropriate care under medical supervision in line with usual clinical care.

Information collected about your baby before the time at which you withdraw from the trial will still be used in the trial analysis, but no further information will be collected.

 If you wish to withdraw and would not like any of the information collected about your baby to be used for the trial this is called ‘withdrawal of data’ and your baby’s doctor or nurse will sign a form confirming that this is your wish. The trial team will keep your baby’s randomisation details and their withdrawal form but all other information collected about them will be deleted/destroyed and not used in the trial analysis.

 

Routine data collection after withdrawal

If you decide to withdraw consent for your baby to take part in the trial at any stage, regardless of whether you allow us to keep previously collected data or not, we will not apply for any routinely collected data from hospitals, laboratories or The Office of National Statistics. For more information on how we use routinely collected information about your baby’s healthcare please click here.

  Withdrawing your baby from routine data linkage

If your baby participated in PREVAIL while they were in hospital, and you did not choose to withdraw them from the trial at any time, then we will use routinely collected information about them from hospitals, laboratories and NHS Digital (click here for more information about how PREVAIL uses this data).

 We use your baby’s NHS number to “link” them to their routinely collected information from NHS Digital, NICUs, PICUs, and Public Health England (click here for more information).

 If you would like to change your mind about this part of the trial you are free to do so without giving a reason. All data about your baby will be anonymised, which means that the people analysing the data will not be able to see your baby’s name or NHS number.

 We expect to be applying for information from NHS Digital in September 2017 after which analysis of the data will commence. Withdrawal after this time point will not be possible.

It is therefore important that if you would like to withdraw your baby from this part of the trial you must let us know before 30th September 2017. Please email prevail@liverpool.ac.uk if you would like to withdraw your baby from data linkage.

 

Optional routine data linkage at school age

When you gave consent for your baby to take part in PREVAIL you may have chosen to also give your consent for us to access your baby’s NHS and education records when they reach school age. This was written on the consent form as:

“I agree that data collected for my baby during this study can be linked to routinely collected electronic NHS and education records when my child reaches school age so that long-term outcomes relating to the PREVAIL study can be investigated.”

You can have a look at our full consent form here.

This was an optional question so you did not have to agree to this for your baby to take part in PREVAIL. If you did not tick and initial this box your baby’s information will not be used. Consenting or not consenting to the optional questions will not affect your baby’s healthcare or involvement in the other aspects of the trial.

 If you did choose to give your consent we may request access to routinely collected information about your child when they reach school age. This data will be “linked” to the information collected about your baby while they took part in PREVAIL. This information is used anonymously, so the researchers will not be able to see your baby’s name or NHS number.

 Any study to look at the long-term outcomes relating to PREVAIL will be approved by a Research Ethics Council to make sure that it is ethical to do this work.

 Withdrawing your baby from data linkage at school age

 If you gave consent for data linkage when your baby reaches school age you are free to change your mind without giving a reason.

Babies who took part in PREVAIL will begin to reach school age in 2020.

If you would like to withdraw your baby from this part of the trial you should let us know before 31st December 2019. Please email prevail@liverpool.ac.uk if you would like to withdraw your baby from data linkage at school age.

 

Last edited on 14th September 2017 by Chloe Middleton

 




I'm fine with this [X]

The site uses cookies, some may have been set already. Please refer to our privacy policy & cookie usage statement.
If you continue to use the site we'll assume you're happy to accept the cookies.