Hypoxic-ischaemic encephalopathy – European Clinical Trials Information Network https://clinicaltrials.eu Bridging Patients with Clinical Trials Thu, 28 May 2026 11:29:10 +0000 en-US hourly 1 https://wordpress.org/?v=7.0 https://clinicaltrials.eu/wp-content/uploads/2024/12/cropped-EU_icon-32x32.png Hypoxic-ischaemic encephalopathy – European Clinical Trials Information Network https://clinicaltrials.eu 32 32 Study of intravenous melatonin safety and dosing in newborns with moderate to severe hypoxic-ischaemic encephalopathy receiving therapeutic hypothermia treatment https://clinicaltrials.eu/trial/study-of-intravenous-melatonin-safety-and-dosing-in-newborns-with-moderate-to-severe-hypoxic-ischaemic-encephalopathy-receiving-therapeutic-hypothermia-treatment/ Wed, 29 Apr 2026 15:06:41 +0000 https://clinicaltrials.eu/trial/study-of-intravenous-melatonin-safety-and-dosing-in-newborns-with-moderate-to-severe-hypoxic-ischaemic-encephalopathy-receiving-therapeutic-hypothermia-treatment/ This study focuses on newborns with hypoxic-ischaemic encephalopathy (HIE), a serious brain condition that occurs when a baby’s brain doesn’t receive enough oxygen around the time of birth. The study will test a new form of melatonin, a substance given through an intravenous infusion, in combination with therapeutic hypothermia (cooling treatment) which is the current standard care for these babies.

The purpose of this research is to determine if giving high doses of melatonin through a vein is safe for newborns with moderate to severe HIE and to find the most appropriate dose for future studies. The study will also measure how the medication moves through the body and monitor the levels of melatonin and the solution it is mixed with in the blood.

During the study, babies will receive different doses of melatonin while undergoing cooling treatment. The medical team will closely monitor the babies’ brain activity using special monitoring equipment, take blood samples to measure drug levels, and perform brain scans called MRI to assess the effects of the treatment. The babies’ development will be followed using various assessment methods to understand how well they progress after the treatment.

]]> Study of Fentanyl Continuous Infusion in Newborns with Hypoxic Ischemic Brain Injury During Cooling Therapy https://clinicaltrials.eu/trial/study-on-continuous-fentanyl-infusion-for-newborns-with-hypoxic-ischemic-encephalopathy-undergoing-therapeutic-hypothermia/ Wed, 29 Apr 2026 15:01:02 +0000 https://clinicaltrials.eu/trial/study-on-continuous-fentanyl-infusion-for-newborns-with-hypoxic-ischemic-encephalopathy-undergoing-therapeutic-hypothermia/ This research focuses on newborns with hypoxic ischemic encephalopathy, a brain condition that occurs when babies don’t receive enough oxygen during birth. These newborns require cooling therapy (therapeutic hypothermia) to protect their brain. The study examines how the pain medication fentanyl works in the bodies of these infants during their cooling treatment.

The study will monitor how fentanyl moves through the body when given through a vein (intravenous administration) to newborns receiving cooling therapy. The medication will be given first as a single dose, followed by continuous administration over several days. The purpose is to understand how newborns’ bodies process this pain medication while they are being treated with cooling therapy.

During the study, doctors will measure the amount of medication in the blood at different times: right after giving the first dose, and then at 24, 48, 72, and 96 hours while the medication is being given continuously. They will also watch carefully for any side effects from the medication to ensure the treatment is safe for these newborns.

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