AuthorisedHuman Pharmacology (Phase I)- OtherInterventional

Continous fentanyl infusion in newborns with hypoxic ischemic encephalopathy treated with therapeutic hypothermia: pharmacokinetics study

This study is investigating how a pain medicine called fentanyl behaves in the bodies of newborn babies. These babies have a brain injury that doctors call 'hypoxic-ischemic encephalopathy' (HIE), which means their brain didn't get enough oxygen around the time of birth. As part of their treatment, these babies are often cooled down, and they might receive fentanyl to help with pain and to keep them comfortable. The main goal of this research is to measure the levels of fentanyl in their blood over time and see how quickly their bodies use or get rid of it. This information will help doctors ensure these vulnerable babies are given the most effective and safest dose of fentanyl, especially when they are undergoing cooling treatment, which can affect how medicines work.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Azienda Ospedaliero Universitaria Di Modena

Enrolment target

Start

05 Aug 2024

Infants with perinatal asphyxiation and indication to hypothermic treatment with analgo-sedation performed with fentanyl

What is this study about?

This study is about understanding how a medicine called fentanyl works in very unwell newborn babies. These babies have a condition known as hypoxic-ischemic encephalopathy (HIE). This means their brain was temporarily short of oxygen or blood flow around the time they were born, which can lead to brain injury. One common and important treatment for HIE is called 'therapeutic hypothermia,' where the baby's body temperature is carefully lowered for a few days to help protect their brain.

While undergoing this cooling treatment, babies need to be kept comfortable and pain-free, which often involves using pain relief medicines like fentanyl. However, cooling a baby's body can change how medicines are processed. This study aims to carefully examine how these tiny, unwell babies react to and process fentanyl. We want to find out how much fentanyl gets into their blood, how long it stays there, and how quickly their bodies break it down and get rid of it. This detailed information about how fentanyl moves through their system is called 'pharmacokinetics.'

By understanding these processes better, doctors can ensure that babies with HIE who are receiving cooling treatment are given the right amount of fentanyl. The goal is to provide effective pain relief and sedation while making sure the medicine is used as safely as possible, avoiding giving too much or too little. This research will help medical teams make more informed decisions about treating these very delicate patients.

Key takeaways

This study helps understand how pain relief medicine (fentanyl) works in newborn babies with brain injury (HIE).
It aims to find the safest and most effective dose of fentanyl for these vulnerable babies.
Babies in the study are already receiving cooling treatment (therapeutic hypothermia) and fentanyl as standard care.
Participation involves extra measurements of fentanyl levels in the baby's blood.
The study has a low risk, as it mainly involves extra monitoring rather than new treatments.
Results will help doctors better care for future babies with HIE.

Who may be eligible?

This study includes newborn babies who have experienced a lack of oxygen or blood flow to their brain around the time they were born, leading to a condition called hypoxic-ischemic encephalopathy (HIE). These are babies who would normally receive specialized cooling treatment to help protect their brains.

There are no specific age limits beyond being a newborn, and the study is open to baby boys and baby girls. The most important factor is that the baby has HIE and is being treated with therapeutic hypothermia, as well as receiving fentanyl for comfort or pain relief as part of their standard care.

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?
Does your baby have hypoxic-ischemic encephalopathy (HIE)?
Is your baby receiving therapeutic hypothermia (cooling treatment)?
Is your baby receiving fentanyl for pain relief or comfort?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they will receive fentanyl as part of their regular medical care for pain relief and comfort, as they would even if they weren't in the study. The main difference is that extra small blood samples will be taken at specific times to measure the levels of fentanyl in their body. These samples will be taken when the fentanyl treatment starts, then at 24, 48, 72, and 96 hours during the infusion. This helps researchers understand how the medicine is working throughout the cooling treatment. There will also be careful monitoring for any side effects of the fentanyl. The total duration of participation will be for the period your baby is receiving the continuous fentanyl infusion during their cooling and rewarming period, which typically lasts around four days.

Potential risks and benefits

The potential benefit of taking part is that the information gathered will help future babies with similar conditions receive safer and more effective pain relief. This study helps improve understanding without changing your baby's treatment plan beyond the extra monitoring. Potential risks are very low, mainly associated with the small, additional blood samples, which are taken by experienced hospital staff. Your baby will be carefully monitored for any known side effects of fentanyl, as they would be in routine care. You are absolutely free to withdraw your baby from the study at any time, for any reason, without affecting their medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Italy

Common questions

What is HIE?

HIE stands for hypoxic-ischemic encephalopathy. It's a type of brain injury that can happen to newborn babies if their brain doesn't get enough oxygen or blood flow around the time of birth.

What is therapeutic hypothermia?

Therapeutic hypothermia is a special treatment for babies with HIE where their body temperature is carefully lowered for a few days. This cooling helps protect their brain from further damage.

What is fentanyl and why is my baby receiving it?

Fentanyl is a strong pain relief medicine. Babies with HIE undergoing cooling treatment might receive it to keep them comfortable and reduce pain or distress.

Will my baby get different care if they join the study?

No, your baby will receive the same medical care and fentanyl dosage regimen they would normally get for their condition. The study mainly involves additional monitoring of fentanyl levels in their blood.

Are there any side effects from fentanyl?

Like all medicines, fentanyl can have side effects, which hospital staff will monitor very carefully. These can include changes in breathing, heart rate, or blood pressure. Your baby will be under constant medical supervision.