I have read the information leaflet and had all my questions answered for me... I consent for my baby to be included in the study... I understand that I can withdraw consent at any time... I consent for my baby’s data to be used for the purposes of the study...
Name of the baby: _ Name of the parent: _ Signature of the parent: _ Date: _
Name of the researcher: _ Signature of the researcher: _ Date: _ _
1 Clamping the Umbilical cord in Premature Deliveries (CUPID): A Randomised Controlled Pilot Trial
Parent Information Leaflet
You are being invited to give your permission for you and your baby to take part in a clinical research study. Before you decide it is important for you to understand why this research is being done and what it will involve. This process is known as informed consent. This leaflet gives detailed information about the research study, which will be discussed with you. Once you understand it fully, you will be asked to sign a consent form if you are happy to take part. A copy of this information leaflet will be given to you to keep. If anything is unclear, or if you would like more information, please do not hesitate to ask us. Take all the time you need to decide if you are to take part.
Why have you been invited to take part?
Your baby is at risk of being born prematurely and so this is why the doctors have provided you with this information. Being born prematurely puts your baby at a higher risk of having immediate and future medical problems. The doctors at Cork University Maternity Hospital are trying to find the best ways to care for premature babies and their mothers’. One of the ways to do this is through research studies like this one.
What is the study about?
At present your baby receives all of his/her blood and oxygen from you via your placenta. The connection between your placenta and your baby is known as the umbilical cord. After your baby is born you are still connected until the doctor cuts the umbilical cord. He/she does this by placing two clamps over the cord and then cutting the cord in between the two clamps. We believe the timing and way in which the doctor clamps the cord may be important for babies born prematurely and this study is investigating what the best approach is for you and your baby.
What are the different approaches to clamping the cord?
There are three options:
1. Immediate cord clamping: The cord will be clamped immediately (less than 20 seconds) after delivery. 2. Delayed cord clamping: The cord will be clamped after one minute. This approach allows for extra blood to
flow from you, and your placenta into your baby before being separated. If your baby needs help to adapt after delivery this will not be affected, as this help will be provided at the bedside on a mobile trolley while you and your baby are still attached by the umbilical cord.
3. Umbilical Cord Milking: The doctor can ‘milk’ the cord and then clamp it. This means that the doctor will push blood down the umbilical cord towards your baby a few times after delivery, and then clamp the cord.
Why is it important to find out which approach is best?
Right now it is not clear which approach is best for you and your baby. Recently, studies from other countries have shown that by increasing the amount of blood your baby receives from you after delivery, either by delaying the clamping of the cord or by milking it, may result in better short term outcomes for premature babies. These include higher blood pressures, which are good for premature babies, less bleeds seen on head ultrasounds and less blood transfusions. These findings are all positive but we still do not know if they result in better long-term neurological outcomes for premature babies. Therefore, at present it is not clear what the best approach is, and more studies are required to find out. The majority still practice immediate cord clamping.
How will we decide what approach is best?
If you decide to take part we will take a blood sample from you the day after your delivery. This will help us decide which approach benefits mothers best. Your baby will have a number of tests all of which are routine investigations in premature infants. They include EEG, Cranial ultrasounds, brain oxygen monitoring, and Echo. These are all monitoring methods used in the intensive care unit. They will help us decide which approach benefits babies best, by looking at your baby’s brain and heart function during the first days after delivery.
2 What is EEG?
EEG stands for electroencephalography. It is a recording of the electrical activity of the brain and is captured using electrodes that are attached to the scalp. Electrodes are like small stickers and are easily removed with water or baby oil after use. They take about 10 minutes to apply and after this they will be left in place for the first few days of life. Our EEG system also uses video to help us study movement patterns during sleep. This video recording is strictly confidential and will not be used for any other purposes.
What are cranial ultrasounds?
You have seen your baby on ultrasound during your pregnancy. We will use a similar but much smaller device to look at your baby’s brain by ultrasound. All premature babies have a head ultrasound in the first few days of life. As part of the study your baby will have an extra one a few hours after being born.
What is NIRS?
Near Infrared Spectrometry (NIRS) is a method that is widely used for assessing the oxygen supply to the brain. NIRS is a test that picks up the oxygen level in the baby’s brain. Similar to the EEG attachments, the NIRS probe (a small sticker) will also be applied to your baby’s forehead and will be kept in place for the first few days of life. Once both tests (EEG and NIRS) are complete, these attachments will be safely removed from your baby’s head.
What is echocardiography?
We will use the ultrasound probe to look at your baby’s heart and the blood flow entering and leaving the heart. It is important to note that these methods of monitoring are standard methods of assessment of preterm infants.