Baby - United Kingdom

University College London Hospitals NHS Foundation Trust


London's Global University
University College London Hospitals NHS Foundation Trust
Department of Neonatology
University College Hospital
235 Euston Road
London NW1 2BU
United Kingdom
Professor Neil Marlow (PI)
Dr Janet Rennie

NEMO-1 study

NEonatal Seizure Treatment with Medication Off-patent: Dose-finding for bumetanide

Information for parents

 

Neonatal seizures and HIE (hypoxic-ischaemic encephalopathy)
(Click Download here for downloading the HIE information sheet)

Your baby showed signs of stress at delivery and may have needed some resuscitation. This means we will need to watch them closely in the Special Care Baby Unit (SCBU) of your hospital.

A small number of babies show signs of stress at delivery. The nurses and doctors caring for the baby may need to help them to breathe, and to cry. Sometimes this stress is a sign that the baby suffered a lack of oxygen or blood supply before their birth.
Most of these babies do very well once they are resuscitated, but they may need to be observed in the Special Care Baby Unit for a day or two. However, some babies will need extra care and support for several days, and some may become very unwell.
The biggest worry for the doctors caring for these babies is that the brain and other organs may have suffered from a lack of blood supply or oxygen. This can cause the baby to cry a lot, or be very sleepy during the first few days. This can be due to some swelling in the baby’s brain. This is called hypoxic-ischaemic encephalopathy or HIE.

Some babies with HIE can have seizures (fits or convulsions) in the first one to three days after birth. These are called neonatal seizures. We know that many babies who have neonatal seizures will have long-term problems. These problems may be in their movement, speech, hearing or learning. These problems can be mild or more severe.

A baby who has neonatal seizures may need several different medicines to control these seizures. The babies with short seizures, which can be stopped quickly using medication, seem to do better. However, the medicines we use in babies with neonatal seizures only work some of the time.

Unlike adults, newborn babies will often remain still and do not jerk during their seizures. The only way that we can monitor their seizures is by measuring their brainwaves, using electroencephalography, or EEG. EEG is often used by doctors to monitor babies who are at risk of seizures.

The doctors in your hospital are involved in a research study to try to find new ways of treating neonatal seizures. This study is called the NEMO study and is taking place in many hospitals all over Europe. If your baby starts to have neonatal seizures the doctors involved in the study will give you more information about the NEMO study. Top

 

Information on the NEMO-1 study (Click Download here for downloading the study information sheet)

  • Why have you asked that my baby take part in NEMO-1?
    Your baby has shown signs of stress after their delivery. The doctors and nurses looking after your baby have noticed that your baby has started to have neonatal seizures (also called fits or convulsions).
    Neonatal seizures can be difficult to treat, and the doctors in your hospital are involved in a research study to look at new ways to treat neonatal seizures. This is called the NEMO-1 study. We are asking you to allow your baby to take part in the NEMO-1 study. Approximately 60 babies will take part in the NEMO-1 study in hospitals across Europe. This sheet gives you information about NEMO-1, which the doctors involved in the study will also discuss with you later.
    You will have a chance to ask questions about the study. Once you understand the study, if you are happy for your baby to take part, we will ask you to sign a consent form. We will give you a copy of this information leaflet and the consent form to keep.

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  • What are the possible benefits of taking part?
    We do not know if the study will help your baby, but the new drug may help your baby. The information we get may help us to treat other babies with seizures in the future. We hope also to get important information about the effects of seizures on a baby’s brain. We will be able to share this information with other parents in the future.

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  • What are neonatal seizures?
    Seizures are caused by to too much electrical activity in the brain. Seizures are sometimes difficult to treat in newborn babies. The drugs, we use to treat seizures in babies do not always work.
    The first drug which most doctors use to treat seizures in a newborn baby is called phenobarbitone. This works to stop seizures in about half of babies treated.
    New research has found that if a drug called bumetanide is given at the same time as phenobarbitone, it may help phenobarbitone to work better. The NEMO-1 study will find out the best dose of bumetanide to use in newborn babies. After this, another study (NEMO-2), will test bumetanide in a larger group of babies.

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  • What is involved for my baby?
    If your baby’s seizures do not stop after the first dose of phenobarbitone, we will give them a second dose of phenobarbitone, and at the same time a single dose of bumetanide. We will give your baby four doses of bumetanide in total over 36 hours.
    We will monitor your baby during the study using EEG (brainwave) monitoring. We will continue this EEG for up to 48 hours to see if the number of seizures your baby has reduces or if the seizures stop altogether.
    To make sure that your baby’s body salts stay safe after their treatment with bumetanide we will need to take small blood samples every eight to twelve hours after they have had this drug for up to 48 hours.
    Whenever possible we will take these samples from a line already in place in your baby. However, sometimes we will need additional blood samples.
    We would like also to keep a small amount (4x0.5ml) of this blood so that we can work out the best dose of bumetanide to give. In total this is about half a teaspoonful that we will take over 60 hours. At the end of the study, we will measure the levels of bumetanide in these samples. We will keep the sample for up to 2 years after the study so we analyse all of the samples at one time. After this the remaining sample will be discarded.
    We would be grateful if you would allow us to contact you at a later date to see how your baby is growing and developing.

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  • Will my baby have any side-effects from this drug?
    High doses of bumetanide have been shown to put babies at a very small risk of hearing loss. In this study, we will use a low dose of bumetanide. However, we will give all babies involved in the study hearing tests before they leave hospital.
    Bumetanide is a drug that has been used for many years to help babies with other conditions and is known to be very safe. This new use may be very helpful. Off-patent medicines are no longer under a patent from the pharmaceutical company that developed them.

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  • Will my baby suffer any side-effects from the EEG?
    The EEG is safe and painless, with no known side effects. We will have to handle your baby to place the EEG discs on the scalp.
    We will attach the discs to your baby’s head with a special soft paste and the discs are connected to a machine. It will record the electrical activity in your baby’s brain.
    As part of the EEG, we may also make a continuous video recording so we can watch your baby’s movements.
    If at any time we consider it unsafe for your baby to continue in the trial we will withdraw them. You can also remove your baby from the trial at any time. After withdrawal we will give them standard medical care. Unless you tell us otherwise, we will use any data we have collected up to the time your baby is withdrawn.

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  • What will happen to the information collected in the study?
    We will make all data collected and stored in the study anonymous. This means we will remove your name and your baby’s name, address and other details and store them separately so we can contact you to arrange follow-up. We will give your baby a NEMO-1 study number and we will use this number to look at the data for the study.

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  • Who is organising and funding the research?
    The European Commission under Framework Programme 7 is funding the study under a scheme to support the use of off-patent medicines to treat important illnesses. Your local hospital ethics committee approved this protocol.
    This trial is insured by Only for Children Pharmaceuticals (O4CP) who will monitor its safety.

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  • Where can I get more Information?
    If you have any questions about this study, you can contact us at:

    Name of local principal Investigator:
    Prof. Neil Marlow
    Address of local principal investigator:
    UCL EGA Institute for Women`s Health
    74 Huntley Street;
    London WC1E 6AU
    United Kingdom
    Phone number of local principal investigator:
    +44 (0) 20 7679 6060
    Email of local principal investigator:
    n.marlow@ucl.ac.uk
    NEMO-1 patient identification number:
    Centre number:
    Form version: 1.0
    Date______/______/_____
    If you agree to take part, the doctors involved in the study will talk to you again during the 48 hours that your baby is taking part. They will be available at any stage to discuss concerns or worries that you may have. If you have a concern about your baby’s clinical care, please ask to speak to your baby’s Consultant Neonatologist who will then meet you to discuss your concerns.
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Download of the consent form of the NEMO-1 study: Please click Download here.

 

Thank you for reading this information about our research study NEMO-1.

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