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Study of Fentanyl Continuous Infusion in Newborns with Hypoxic Ischemic Brain Injury During Cooling Therapy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial medication administration

    You will receive an initial dose (starting bolus) of fentanyl at 2 micrograms per kilogram of body weight

    The medication will be given through an intravenous line (a small tube inserted into your vein)

  2. Step 2

    Continuous medication phase

    After the initial dose, you will receive continuous fentanyl at 1 microgram per kilogram per hour

    This continuous administration will continue throughout the therapeutic hypothermia (cooling) and heating phases

  3. Step 3

    Blood sampling schedule

    Blood samples will be collected at the following times:

    - Before starting the medication (zero-time)

    - Within 30 minutes after the initial dose

    - At 24 hours after starting

    - At 48 hours after starting

    - At 72 hours after starting

    - At 96 hours after starting

  4. Step 4

    Monitoring phase

    Throughout the treatment, medical staff will monitor for any side effects of the medication

    Your vital signs and overall condition will be continuously monitored

Who can join the trial?

12 criteria

  • Must be a newborn baby requiring cooling treatment (hypothermic treatment) for birth-related oxygen deprivation (perinatal asphyxia)
  • Must be born at or after 35 weeks of pregnancy (gestational age ≥ 35 weeks)
  • Must weigh more than 1.8 kg at birth (birth weight > 1.8 kg)
  • Must have at least one of these conditions:
    • Low health score at 5 minutes after birth (Apgar Score ≤ 5)
    • Required ongoing resuscitation at 10 minutes after birth
    • Blood tests showing low pH (less than 7.0) or high base deficit (more than 12) within first hour after birth
    • Must show signs of brain dysfunction (encephalopathy)
    • Must have either:
      • Moderate to severe brain activity abnormalities on monitoring (aEEG anomalies)
      • Seizures
      • Must start cooling treatment (controlled hypothermia) within 6 hours after birth
      • Parents must provide written consent for study participation
      • Must be able to receive the study's pain medication

Who cannot join the trial?

10 criteria

  • Infants who do not meet the criteria for hypothermic treatment (a cooling therapy used to reduce brain injury)
  • Infants who are not receiving fentanyl (a strong pain medication) for sedation and pain control
  • Infants who do not have a history of perinatal asphyxia (lack of oxygen during or immediately after birth)
  • Infants who are receiving other types of pain medications or sedatives besides fentanyl
  • Infants with severe congenital abnormalities (birth defects)
  • Infants with active bleeding disorders
  • Infants whose parents or legal guardians have not provided informed consent
  • Infants who are participating in other clinical trials
  • Infants with severe liver or kidney dysfunction
  • Infants who are not within the newborn period (first 28 days of life)
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Investigated drugs

Fentanyl is a strong pain-relieving medication (opioid) used to manage pain and provide sedation. In this trial, it is used as a continuous infusion to help newborn babies who have experienced a lack of oxygen at birth and are receiving cooling therapy. The medication helps keep the babies comfortable and reduces stress during their treatment. It works by binding to specific receptors in the brain and nervous system to decrease pain sensation.

What is already known about the treatment

Fentanyl - A potent synthetic opioid pain medication administered through intravenous infusion, particularly used in clinical settings for pain management and sedation. In neonatal care, it's specifically used for analgo-sedation in infants undergoing therapeutic hypothermia treatment following perinatal asphyxia, where careful dosing is essential due to its powerful effects. The medication works by binding to opioid receptors in the brain and spinal cord, effectively reducing pain perception and providing sedation, while its pharmacological classification places it in the opioid analgesic drug class. The drug's pharmacokinetics are of particular interest in newborns with hypoxic ischemic encephalopathy, as their metabolism and response to the medication may be affected by both their condition and the cooling therapy they receive.

Investigated diseases

Perinatal Asphyxia - A condition that occurs when a newborn doesn't receive enough oxygen before, during, or immediately after birth. This oxygen deprivation can affect various body organs, particularly the brain. The condition develops when there is a decrease in blood flow or oxygen to the baby during the birth process. It can cause the baby to have breathing difficulties and decreased heart rate immediately after birth. The severity of the condition can vary from mild to severe, with different effects on the baby's body systems. Babies affected by this condition may show signs of poor muscle tone and decreased responsiveness.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase ITrial ID2024-516076-15-00Protocol codeFentanylTHEstimated enrolment20 patientsSponsorAzienda Ospedaliero Universitaria Di Modena

sourced from the EU Clinical Trials Register and site verification

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