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Study on Remifentanil and Sodium Chloride for Safe Intubation in Stable Newborns

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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 the use of remifentanil for helping with the process of endotracheal intubation in newborns. Endotracheal intubation is a medical procedure where a tube is placed into a baby's windpipe to help them breathe. The study involves newborns who are stable in terms of their heart and blood pressure and need this procedure done in a planned manner. The main goal is to find the right dose of remifentanil that provides effective sedation, which means making the baby calm and comfortable during the procedure, with minimal side effects.

The trial will use remifentanil, a medication given through an injection, to see how well it works in providing the right conditions for intubation. Another solution, sodium chloride, will be used to help with the administration of the medication. The study will observe how the babies respond to the medication, focusing on how well they are sedated and how smoothly the intubation process goes. The researchers will also monitor for any side effects, such as changes in heart rate or breathing, to ensure the safety of the newborns.

The study aims to determine the best dose of remifentanil for newborns, both those born at full term and those born prematurely, to ensure the procedure is as safe and effective as possible. The researchers will assess the level of sedation by gently stimulating the baby's foot and observing their response. The trial will also look at how quickly the babies recover their normal breathing after the procedure and check for any other health concerns that might arise. This research is important for improving the care and comfort of newborns who need this critical medical procedure.

The research process

The trial runs in 6 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 legal representatives of the neonate must provide written informed consent. This is a formal agreement to participate in the study.

  2. Step 2

    Eligibility confirmation

    The neonate must be hemodynamically stable, meaning they have a normal mean blood pressure and are not using medications that affect heart function. The neonate should be at least 26 weeks gestational age and require semi-elective endotracheal intubation.

  3. Step 3

    Administration of medication

    The neonate will receive a medication called remifentanil through an intravenous route. This means the medication is given directly into a vein. The purpose of this medication is to provide sedation, which helps in performing the intubation procedure effectively.

    Along with remifentanil, a solution of sodium chloride (NaCl 0.9%) may also be administered intravenously. This is a common practice to ensure the proper delivery of medications.

  4. Step 4

    Intubation procedure

    The neonate will undergo a procedure called endotracheal intubation. This involves placing a tube into the windpipe to help with breathing. The conditions for intubation are assessed immediately after the procedure using a scoring system to ensure adequate sedation and successful intubation.

  5. Step 5

    Monitoring and assessment

    After the intubation, the level of sedation is assessed by observing the neonate's response to a gentle stimulus, such as rubbing the sole of the foot. The response is scored to determine the effectiveness of the sedation.

    Safety is monitored by checking for any side effects like slow heart rate, low blood pressure, breathing difficulties, or muscle stiffness. The ease of ventilation and time taken for successful intubation are also evaluated.

  6. Step 6

    Follow-up and conclusion

    The neonate is observed for the return of normal breathing and any additional medical assessments are conducted, such as checking blood gas values and the need for any additional medication.

    The trial aims to determine the optimal dose of remifentanil that provides effective sedation with minimal side effects for neonates undergoing intubation.

Who can join the trial?

4 criteria

  • The baby must be a hemodynamic stable neonate, which means having a normal mean blood pressure without needing medications to support heart function.
  • The baby needs to require semi-elective endotracheal intubation, which is a planned procedure to help with breathing.
  • The baby must be at least 26 weeks gestational age, meaning they have been developing in the womb for at least 26 weeks.
  • Written informed consent must be obtained from the baby's legal representatives, which means the parents or guardians agree to the baby's participation in the study.

Who cannot join the trial?

6 criteria

  • Patients who are not hemodynamically stable. This means their blood circulation is not stable enough.
  • Patients who do not require semi-elective endotracheal intubation. This is a procedure where a tube is placed into the windpipe to help with breathing, planned but not urgent.
  • Patients who have any known allergies or adverse reactions to remifentanil, a medication used for sedation.
  • Patients with any condition that the study doctors believe would make it unsafe to participate.
  • Patients who are not within the age range specified for the study.
  • Patients who are not able to provide consent, or whose guardians cannot provide consent on their behalf.
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Investigated drugs

Remifentanil is a medication used to help with sedation during medical procedures. In this clinical trial, it is being studied to find the best dose for newborns who need a tube placed in their windpipe to help them breathe. The goal is to find a dose that works well for sedation while causing the least amount of side effects. This medication is given before the procedure to make sure the baby is comfortable and relaxed. The study aims to determine the right amount needed to achieve effective sedation in most newborns.

What is already known about the treatment

Remifentanil – Remifentanil is administered intravenously, meaning it is given directly into a vein through an injection or infusion. It is currently being studied in clinical trials to determine the best dose for use in newborns who need help with breathing through a procedure called endotracheal intubation. This medication is mainly used to provide sedation and pain relief during medical procedures. At the molecular level, remifentanil works by binding to specific receptors in the brain and nervous system, which helps to reduce pain and induce sedation. It is classified as an opioid analgesic, a type of medication commonly used for pain management.

Investigated diseases

Hemodynamic Stable Term and Preterm Neonates Requiring Semi-Elective Endotracheal Intubation – This condition involves newborns, both full-term and preterm, who need a planned but not urgent procedure to insert a tube into their windpipe to help them breathe. The procedure is necessary when the baby is stable in terms of blood flow and heart function but still requires assistance with breathing. The progression involves preparing the neonate for intubation, ensuring they are calm and sedated to minimize stress and discomfort. During the procedure, the baby's breathing is supported, and their vital signs are closely monitored. The goal is to achieve successful intubation with minimal side effects, ensuring the baby remains stable throughout the process. After intubation, the focus is on maintaining adequate ventilation and monitoring for any complications.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2022-501858-11-00Protocol codeBC-09897Estimated enrolment50 patientsSponsorUniversitair Ziekenhuis Gent

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