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Study on Premedication with Ketamine or Fentanyl for Patients with Respiratory Distress Syndrome Receiving Surfactant Treatment

Registered 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 Respiratory Distress Syndrome, which affects breathing. The trial is investigating two medications, Fentanyl and Esketamine, to see which one is better for premedication before a procedure called less invasive surfactant administration. Surfactant is a substance that helps the lungs function properly, and this procedure is used to deliver it to the lungs in a gentler way.

The purpose of the study is to determine which medication, Fentanyl or Esketamine, is safer and more effective when used as premedication. Participants in the study will receive either one of these medications or a placebo before undergoing the surfactant administration procedure. The study will monitor for any side effects and measure how well the medications work in reducing these effects.

The trial will take place over a period of time, with participants being closely observed to ensure their safety and to gather data on the effectiveness of the medications. The goal is to find out which medication leads to fewer adverse events, making it the preferred choice for premedication in this procedure.

The research process

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

Step 1
Joining the trial
Upon joining the clinical trial, you will be assessed to ensure you meet the necessary criteria. This includes having a gestational age at birth of at least 26 weeks and experiencing respiratory insufficiency that is managed with non-invasive support, such as nasal CPAP or high-flow oxygen therapy.
You must also require oxygen to maintain your oxygen saturation within the target range and need surfactant treatment as determined by a clinician.
Step 2
Receiving premedication
As part of the trial, you will receive premedication to prepare for the less invasive surfactant administration. The premedication will be either fentanyl citrate or esketamine hydrochloride, both administered as a solution for injection.
The medication will be given through an intravenous bolus, which means it will be injected directly into your vein in a single, quick dose.
Step 3
Monitoring and procedure
During the procedure, your vital signs will be closely monitored. This includes your heart rate, blood pressure, and oxygen levels to ensure your safety.
The primary goal is to administer the surfactant with minimal discomfort and to observe any adverse events, such as the need for additional ventilation support or changes in vital signs.
Step 4
Evaluation of outcomes
The trial aims to determine which premedication, either ketamine or fentanyl, is associated with fewer adverse events and is more effective and safe for the procedure.
Secondary outcomes include the duration of the procedure, the number of attempts needed to place the catheter, and the assessment of pain using a specific pain score.
Step 5
Completion of trial participation
Once the procedure and monitoring are complete, your participation in the trial will conclude. The data collected will contribute to understanding the best practices for premedication in less invasive surfactant administration.

Who can join the trial?

5 criteria

The baby must be born at a **gestational age** of at least 26 weeks. Gestational age is the number of weeks the baby has been in the womb.
The baby must have **respiratory insufficiency** and be managed with non-invasive respiratory support. Respiratory insufficiency means the baby is having trouble breathing.
The baby must need oxygen to keep their oxygen levels in the right range and require **surfactant treatment**. Surfactant treatment is a therapy to help the baby's lungs work better.
Both male and female babies can participate.
The study includes babies who are considered a vulnerable population, meaning they need special protection and care.

Who cannot join the trial?

6 criteria

Patients who are not experiencing respiratory distress syndrome. This is a condition where the lungs cannot provide enough oxygen to the body.
Patients who have not received surfactant treatment. Surfactant is a substance that helps keep the lungs open so that breathing is easier.
Patients who have not been given premedication. Premedication involves giving medicine before a procedure to help with comfort and safety.
Patients who are not within the specified age range for the study.
Patients who do not belong to the clinical trial group specified for the study.
Patients who are not part of the vulnerable population selected for the study. A vulnerable population may include groups like children or the elderly who need special protection.

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Investigated drugs

Ketamine
is a medication used in this trial as a premedication option. It is often used for its sedative and pain-relieving properties. In this study, ketamine is being evaluated to see if it can help reduce adverse events when used before a procedure called Less Invasive Surfactant Administration (LISA).
Fentanyl
is another medication being tested as a premedication in the trial. It is a strong pain reliever that is commonly used to manage pain and provide sedation. The study aims to determine if fentanyl is effective and safe in reducing adverse events during the LISA procedure.

What is already known about the treatment

Ketamine
Ketamine is administered intravenously or intramuscularly and is currently used in medical practice as an anesthetic and for pain management. It is being studied in clinical trials for its potential use in premedication for less invasive surfactant administration in respiratory distress syndrome. Ketamine works by blocking NMDA receptors in the brain, which helps reduce pain and induce sedation. It is classified as a dissociative anesthetic.
Fentanyl
Fentanyl is administered intravenously and is widely used in medicine for pain relief and as an anesthetic. In clinical trials, it is being evaluated for its effectiveness as a premedication in less invasive surfactant administration for respiratory distress syndrome. Fentanyl acts by binding to opioid receptors in the brain, providing pain relief and sedation. It is classified as an opioid analgesic.

Investigated diseases

Respiratory Distress Syndrome – This condition occurs when the lungs cannot provide enough oxygen to the body, often due to a lack of surfactant, a substance that helps keep the air sacs in the lungs open. It is most common in premature infants whose lungs are not fully developed. The disease progresses as the lungs struggle to expand and contract properly, leading to difficulty breathing. As the condition advances, the body may not receive enough oxygen, causing further complications. Surfactant treatment is often used to help improve lung function and ease breathing.