Information for Parents

This page includes information for parents related to the NEO-CIRC 003 study.

This study has been designed by a group of experts and specialist doctors from the UK, Europe and the USA who have been working together to find out the best way to help premature babies when their heart does not pump effectively after birth.

We would like to compare three existing ways to help these babies. We will closely observe these babies using various tests to see whether their situation improves and determine which tests are more useful.

Who has reviewed the study?

All research that involves NHS patients has been approved by an NHS Research Ethics Committee before it goes ahead, to protect the rights and best interests of everyone involved. Approval means that the Committee is satisfied that your rights will be respected, that any risks have been reduced to a minimum and balanced against possible benefits, and that you have been given enough information to make an informed decision to take part or not.

Do I/does my baby have to take part?

No, whether you or your baby takes part or not is entirely up to you. If you decide to take part, your decision must be the right choice for you and your baby. A doctor or nurse will discuss the study with you and answer any questions you have. Your baby’s care will not be affected in any way if you decide you do not want to take part in the study.

If you decide you would like to take part, you can change your mind at any time and withdraw your baby from the study by telling the medical team. You don’t have to give a reason.

You will be asked if we can use the data already collected to help with the ongoing work.

What will happen if I do take part?

If you agree to take part, a doctor or nurse involved in the study will give you some more in depth information about exactly what is involved. They will give you as much time as you need to consider being involved, and the opportunity to ask any questions. If you do agree to take part, you’ll be asked to sign a consent form saying you understand what is involved for you and your baby. However, if at any point you change your mind you can withdraw without having to give a reason.

There are some parts of research that we’re often not very good at explaining. Whilst different studies have different designs, some of the most important but complicated ones involve randomisation or placebo.

Randomisation

Randomisation is only used in situations where we are completely unsure of whether one treatment or intervention is better than the other. Randomisation is not a way of allocating scarce resources or treatments known to be superior. By dividing parents or babies into two groups we can directly compare treatments or interventions.

The decision about which treatment you receive is decided by chance, rather like tossing a coin, so there will be a 50:50 chance of receiving either treatment. Most often, participants will be randomised to receive either one of the standard treatment that’s in use in the department, or a new treatment. If there is no standard treatment, half of the group may be given ‘placebo’ and half the new treatment.

Placebo

A placebo is a treatment which looks like a genuine medicine but contains no active ingredient. We do know that placebos can still have both positive effects and side effects, just like any medication. Placebo medications are used as a comparison to a medication we’re testing, when we have no evidence that the new medication is effective.

What will happen to the results of the research study?

At the end of the study, the results will be analysed and may be published in medical journals. We will send you a summary of the final results of the study. The results will be made anonymous, so you and your baby will not be identified in any report or publication about the study.

News

This section will contain study specific updates for parents, e.g. recruitment numbers, medical/research updates in lay language, etc.

The Importance of Research

The maternity and newborn baby units are committed to participating in research to ensure the best care for our patients, both now and in the future.

The people who do research are mostly the same doctors and healthcare professionals who treat people. Research allows us to try to fill in these knowledge gaps and provide evidence to improve the care provided to women, babies and families during pregnancy, childbirth and the newborn period, and your involvement in studies and trials is really important.

For more information on clinical research at Brighton and Sussex University Hospitals and the Trevor Mann Baby Unit please visit:

Contact Details

If you wish to discuss any aspect of the study you can contact us using the details below.

Name and contact details of local study team:

Dr Ramon Fernandez
Consultant Neonatologist
Local Principal Investigator
Trevor Mann Baby Unit
Royal Sussex County Hospital
Eastern Road
Brighton BN2 5BE, UK
Email: ramon.fernandez@bsuh.nhs.uk
Phone: 01273 696955 ext. 4195 

Sonia Sobowiec Kouman
Neonatal & Paediatric Research Nurse
Royal Alexandra Children's Hospital
Level 6, room 605
Eastern Road
Brighton BN2 5BE, UK
Email: paedneoresearch@bsuh.nhs.uk
Phone: 01273 696955 ext. 2396

Name and contact of Sponsor & Chief Investigator:

Servicio Madrileño de Salud (SERMAS)

Adelina Pellicer, MD, PhD
Head of Neonatology
La Paz University Hospital
Paseo de la Castellana 261
28046-Madrid, Spain
Phone: +34 91 72774169

Name and contact of UK lead:

Brighton and Sussex University Hospitals NHS Trust (BSUH)
PD Dr Heike Rabe
Reader in Paediatrics/ Honorary Consultant Neonatologist
Trevor Mann Baby Unit
Royal Sussex County Hospital
Eastern Road
Brighton BN2 5BE, UK
Phone: 01273 696955 ext. 4195 2409

 

Independent Advice

If you would like to contact an independent organisation to discuss the inclusion of babies in research studies generally, we suggest that you contact Bliss, the special care baby charity. Bliss helps premature and sick babies by supporting parents and families, campaigning for improvements in neonatal care and promoting new developments and innovations in care. Bliss contact details are: www.bliss.org.uk

Best Beginnings is another charity dedicated to ending child health inequalities in the UK; click on the following link to access their site: www.bestbeginnings.org.uk

Best Beginnings have produced a Small Wonders information pack with a DVD and guidebook to tell mothers what to expect when a baby arrives earlier than expected or is sick: www.bestbeginnings.org.uk/small-wonders

Patient Information Leaflets