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Study on Sildenafil and Hypothermia for Newborns with Hypoxic-Ischemic Encephalopathy

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying a condition known as hypoxic-ischemic encephalopathy in newborns. This condition occurs when a baby's brain doesn't receive enough oxygen and blood, which can lead to brain damage. The study will explore the effects of a treatment combining sildenafil and controlled cooling, also known as hypothermia, to see if it can improve survival without brain injuries. Sildenafil is a medication that is being tested in this study in the form of a solution for injection.

The purpose of the study is to determine if the combination of sildenafil and hypothermia is more effective than hypothermia alone. The study will be conducted in two steps. In the first step, researchers will examine how the body processes sildenafil in newborns with the condition. In the second step, the study will compare the outcomes of newborns receiving the combination treatment to those receiving a placebo, focusing on survival without brain lesions as seen on an MRI scan at the time of hospital discharge.

Throughout the study, researchers will monitor various aspects of the newborns' health, including brain activity and heart function, to assess both the potential benefits and safety of the treatment. The study aims to provide valuable insights into whether this treatment approach can help improve outcomes for newborns affected by hypoxic-ischemic encephalopathy.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the neonate must be born at or after 36 weeks of gestation and diagnosed with hypoxic ischemic encephalopathy (HIE).

    The neonate will be treated with therapeutic hypothermia, which involves maintaining a body temperature of 33.5 ± 0.5 °C.

  2. Step 2

    Beginning treatment

    The experimental treatment will start after more than 1 hour of active hypothermia and within the first 12 hours of life.

    The neonate will receive sildenafil intravenously, which is a solution for injection, as part of the treatment.

  3. Step 3

    Monitoring and assessments

    During the trial, the primary focus will be on measuring the plasma concentrations of sildenafil to understand how the body processes the medication.

    The neonate's survival without brain lesions will be assessed using an MRI scan between the end of rewarming (day 3.5) and day 5.

  4. Step 4

    Secondary assessments

    Additional assessments will include changes in EEG patterns, detailed analysis of MRIs, and spectroscopy.

    A 2-year follow-up will assess neurodevelopmental outcomes, including potential autism spectrum disorders.

  5. Step 5

    Safety evaluations

    Safety evaluations will include monitoring for low systemic pressure that may require support and assessing cardiac function.

Who can join the trial?

5 criteria

  • Newborns born at or after 36 weeks of pregnancy.
  • Newborns treated with a special cooling treatment called therapeutic servo-controlled hypothermia (temperature set at 33.5 ± 0.5 °C) for a condition known as neonatal HIE.
  • The experimental treatment will start more than 1 hour after the cooling treatment begins and less than 12 hours after birth.
  • The newborn must have social security coverage.
  • One of the parents or legal guardians must provide written consent for the newborn to participate in the study.

Who cannot join the trial?

4 criteria

  • Patients with conditions other than Hypoxic Ischemic Encephalopathy (a type of brain injury caused by lack of oxygen).
  • Patients who are not newborns (neonates) born after 36 weeks of pregnancy.
  • Patients who are not undergoing treatment with controlled cooling (hypothermia).
  • Patients who are not eligible for treatment with IV sildenafil (a medication used in this study).
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Investigated drugs

Sildenafil is a medication that is being studied in this trial for its potential benefits in newborns with a condition called hypoxic-ischemic encephalopathy (HIE). This condition occurs when a baby’s brain does not receive enough oxygen and blood. In this trial, sildenafil is given through an IV, which means it is administered directly into the bloodstream. The researchers want to see if sildenafil can help improve the chances of survival without brain damage when used alongside a treatment called controlled hypothermia. Controlled hypothermia is a therapy where the baby’s body temperature is lowered to help protect the brain from further injury.

What is already known about the treatment

Sildenafil – Sildenafil is administered intravenously, meaning it is given directly into a vein, and is being studied for its potential benefits in newborns with a condition called hypoxic ischemic encephalopathy, which is a type of brain injury caused by lack of oxygen. Currently, this medication is being evaluated in clinical trials to see if it can improve survival without brain damage when used alongside controlled cooling treatments. Sildenafil works by relaxing blood vessels, which can improve blood flow and oxygen delivery to tissues. It is classified as a phosphodiesterase type 5 (PDE5) inhibitor, a group of drugs that are often used to treat conditions related to blood flow.

Investigated diseases

Hypoxic ischemic encephalopathy – This condition occurs when the brain does not receive enough oxygen and blood flow, often around the time of birth. It can lead to brain cell damage due to the lack of oxygen and nutrients. The progression of the disease can vary, with some infants experiencing mild effects and others facing more severe neurological issues. Initially, symptoms may include difficulty breathing, poor muscle tone, and seizures. Over time, affected infants may develop problems with movement, learning, and other developmental milestones. The severity of these issues depends on the extent of the initial brain injury.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IVTrial ID2023-508928-35-00Protocol codeAPHP180603Estimated enrolment556 patientsSponsorAssistance Publique Hopitaux De Paris

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