SHINE trial - Effect of Sildenafil in association to Hypothermia on survival without brain lesions In term Neonates with hypoxic-ischemic Encephalopathy: a randomized, double-blinded, placebo-controlled, multicenter trial
This important study, called SHINE, is for newborn babies who have experienced a lack of oxygen around birth, which can sometimes affect their brain. Doctors are testing a medicine called sildenafil (you might know it as Revatio in other situations) alongside a standard cooling treatment often given to these babies. The main goal is to find out if this combination helps babies survive without brain damage. Researchers will be checking the medicine levels in babies' blood and carefully looking at brain scans (MRIs) to see if the treatment is working. They will also follow the babies' development for two years to understand any long-term effects.
At a glance
What is this study about?
When a baby doesn't get enough oxygen during birth, it can sometimes cause brain injury. This condition is called hypoxic-ischemic encephalopathy, but you might hear it simply referred to as a lack of oxygen at birth causing brain problems. One common treatment for this is 'cooling therapy,' where the baby's body temperature is gently lowered for a few days to help protect their brain.
This specific study, called SHINE, is looking to see if adding an existing medicine called sildenafil (sometimes known as Revatio) to the usual cooling treatment can offer even more protection. Sildenafil affects blood flow, and researchers want to see if this effect could help the baby's brain recover better after being starved of oxygen.
The study has two main parts. First, they want to understand how the baby's body handles the sildenafil medicine – how much is absorbed and how it moves through their system. The second and most important part is to see if babies who receive sildenafil along with cooling are more likely to survive without brain damage, compared to those who just get cooling and a dummy medicine (placebo). They will check this using special brain scans (MRIs) and by following the babies' development for up to two years to look for any long-term effects.
Key takeaways
- This study is testing a drug called sildenafil with standard cooling treatment for babies who lacked oxygen at birth.
- The main aim is to see if this combination helps babies survive without brain damage.
- Babies in the study will receive either sildenafil or a dummy medicine, plus cooling.
- Brain scans (MRIs) and blood tests are key parts of the study.
- Babies' development will be checked up to two years of age.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
This study is designed for all newborn babies, regardless of whether they are a boy or a girl. The most important factor for joining the study is that the baby has experienced a lack of oxygen during birth, leading to a condition that affects their brain.
The medical team will carefully review each baby's health to ensure that participating in the study is safe and appropriate for them. There will be specific medical criteria that your baby needs to meet to be considered for the study.
If your baby meets the initial criteria, the doctors will have a detailed discussion with you about the study to help you decide if it's the right choice for your family.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Is my baby a newborn?
- Did my baby experience a lack of oxygen around birth?
- Has a doctor said this lack of oxygen affected my baby's brain?
- Is my baby well enough to potentially receive this treatment, as determined by the hospital team?
What does participation involve?
If your baby takes part in this study, they will receive either the study medicine (sildenafil) or a dummy medicine (placebo), in addition to the standard cooling treatment. The doctors and nurses, and even you, won't know which one your baby is getting – this is called a 'double-blind' study and helps make the results fairer.
Your baby will have their blood tested regularly to check the levels of the medicine, if they are receiving it. There will also be brain scans, called MRIs, usually done within a few days after the cooling treatment finishes. Doctors will also monitor your baby's general health, including their heart function and blood pressure.
After leaving the hospital, there will be follow-up appointments when your child is two years old. These appointments will assess their development and well-being, looking at things like learning, social skills (using tools like the M-CHAT for autism), and overall growth. The total duration of participation includes the initial hospital stay and these follow-up checks until your child is two years old.
Potential risks and benefits
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Common questions
What is 'hypoxic-ischemic encephalopathy'?
It's a medical term for brain injury in a newborn baby caused by a lack of oxygen during or around birth.
What is sildenafil?
It's a medicine that can affect blood flow. In this study, doctors are investigating if it can help protect the baby's brain.
Will my baby definitely get the study drug?
No, your baby will either get the study drug (sildenafil) or a dummy medicine (placebo), chosen randomly. Neither you nor the doctors will know which one it is.
What is the cooling treatment?
It's a standard treatment where a baby's body temperature is gently lowered for a few days to help protect their brain after a lack of oxygen.
How long will my baby be followed after leaving the hospital?
Your child will have follow-up assessments when they are two years old to check their development.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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