Active not recruitingPHASE1INTERVENTIONAL

Sildenafil to Repair Brain Injury Secondary to Birth Asphyxia

This study is investigating a medicine called sildenafil for babies who have suffered a brain injury during birth due to a lack of oxygen (birth asphyxia). These babies are already receiving a standard treatment called therapeutic hypothermia, which involves cooling their bodies. Researchers want to find the safest and most effective dose of sildenafil to give to these vulnerable newborns. They will also observe how the medicine works in their bodies and if it has any positive effects on their brain and heart health, without causing serious side effects. The goal is to see if sildenafil can offer additional protection and help improve outcomes for these babies.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Enrolment target

Start

19 Sep 2019

Estimated completion

01 Dec 2024

Birth Asphyxia

What is this study about?

Birth asphyxia is a serious condition where a baby doesn't get enough oxygen during birth. This can lead to brain injury. Currently, a common treatment for these babies is therapeutic hypothermia, which involves carefully cooling their bodies to help protect the brain. This study is exploring whether a medicine called sildenafil could provide additional benefits.

Sildenafil is a medicine known to improve blood flow, and researchers believe it might help protect the brain cells and improve how the heart and lungs work in these critically ill babies. This particular study is an early-stage trial (Phase 1). This means the main goal is to carefully find out what the safest dose of sildenafil is for these newborns and to understand how their bodies handle the medicine. They will start with small doses and gradually increase them, all while closely monitoring the babies for any side effects.

Ultimately, by finding the right dose and understanding how sildenafil works in these babies, the researchers hope to see if this medicine could one day become part of a new treatment to help babies recover better from brain injury caused by birth complications. They will be looking for any signs that sildenafil might improve brain and heart function without causing new problems.

Key takeaways

The study is for newborn babies with brain injury due to lack of oxygen at birth.
It's testing a medicine called sildenafil to see if it helps protect the brain and heart.
The main goal is to find the safest dose of sildenafil for these vulnerable babies.
Babies in the study will also receive standard cooling treatment.
Participation involves close monitoring by doctors.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

This study is looking for newborn babies who meet specific criteria related to brain injury caused by a lack of oxygen during birth. To beconsidered, a baby must have been born after at least 36 weeks of pregnancy and weigh at least 1.8 kilograms (about 4 pounds). There must also be clear signs that the baby had problems during or immediately after birth, such as a low Apgar score, issues with their blood oxygen levels, or needing help with breathing.

Another important requirement is that the baby shows signs of a moderate to severe brain problem (called neonatal encephalopathy), based on a medical examination or special brain monitoring. Crucially, a brain scan (MRI) performed around the second day of life must also show evidence of a brain injury.

However, some babies would not be able to join the study. This includes those with serious heart defects, unusual brain development, certain genetic conditions, or significant bleeding inside the brain that is visible on their initial brain scan.

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 your baby a newborn (up to 2 days old)?
Was your baby born after at least 36 weeks of pregnancy and weigh over 1.8kg (about 4 lbs)?
Did your baby experience problems with oxygen at birth?
Does your baby show signs of brain injury on a brain scan (MRI)?
Does your baby NOT have severe heart problems, unusual brain development, genetic conditions, or brain bleeding?

Answer every question to see your result.

What does participation involve?

If your baby is eligible and you agree for them to participate, they will receive sildenafil as doctors try to find the safest dose. The medicine will be given under close medical supervision. Throughout the study, your baby will have regular medical check-ups, blood tests, and scans to monitor their health, the effects of the medicine, and how their brain and heart are doing. All babies in the study will also continue to receive their standard cooling treatment. The study involves giving the medication and monitoring for a short period, typically from birth up to around two days of age, while they are already in intensive care.

Potential risks and benefits

Participating in a study like this means your baby will receive close medical attention and monitoring. While sildenafil is a known medicine, its effects in newborns with brain injury are still being studied, so there's no guarantee it will directly benefit your baby. There's a potential that sildenafil could help protect your baby's brain and heart, but there are also potential risks and side effects, which doctors will explain fully and monitor for carefully. You have the full right to withdraw your baby from the study at any time, for any reason, without it affecting their ongoing medical care.

Locations (1)

Montreal Children's Hospital
Verified postcode
Montreal, Canada

Common questions

What is birth asphyxia?

Birth asphyxia means a baby didn't get enough oxygen before, during, or right after birth, which can sometimes lead to brain injury.

What is sildenafil?

Sildenafil is a medicine that can help improve blood flow, and researchers are studying if it can help protect the brains and hearts of newborn babies.

What is therapeutic hypothermia?

This is a standard treatment where doctors carefully cool a baby's body to help protect their brain after a lack of oxygen at birth.

Why is this study being done?

Researchers want to find the safest dose of sildenafil for babies with birth brain injury and see if it helps their recovery alongside standard treatments.

Will my baby still get their regular care?

Yes, all babies in the study will continue to receive their usual medical care, including cooling treatment, alongside the study medication.