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Study on the Effects of Propofol Sedation in Preterm Babies with Respiratory Distress Syndrome During LISA Procedure

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 the effects of a treatment method called LISA, which stands for Less Invasive Surfactant Administration, in preterm babies who are born before 32 weeks of pregnancy and are experiencing a condition known as Respiratory Distress Syndrome. This condition affects the lungs and makes it difficult for the baby to breathe. The study will compare the use of a medication called Propofol, which is used for sedation, to a placebo during the LISA procedure. The goal is to see if using Propofol helps reduce the need for mechanical ventilation, which is a machine that helps with breathing, within the first 72 hours of the baby's life.

In addition to Propofol, the study may involve the use of another medication called Ketamine if additional sedation is needed. The trial will monitor various outcomes, including the rate of mechanical ventilation required, the comfort level of the babies during the procedure, and any potential side effects. The study will also assess the babies' health at different stages, such as at 36 weeks of gestational age and at two years old, to evaluate their development and any long-term effects.

The trial is designed to be double-blind, meaning neither the healthcare providers nor the participants will know who is receiving Propofol or the placebo, to ensure unbiased results. The study aims to provide valuable information on the best practices for treating Respiratory Distress Syndrome in preterm infants, potentially improving their care and outcomes.

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 clinical trial, the preterm infant, born before 32 weeks of gestation, is assessed for eligibility. This includes having a condition known as Respiratory Distress Syndrome (RDS) within the first 48 hours of life and being treated with CPAP or BiPAP, which are types of breathing support.

    The infant must require a substance called surfactant to help with breathing. An intravenous line must be available for administering medications.

  2. Step 2

    Randomization and initial procedure

    The infant is randomly assigned to one of two groups: one receiving sedation with propofol and the other receiving a placebo during the LISA (Less Invasive Surfactant Administration) procedure.

    The LISA procedure involves administering surfactant to help the infant breathe more easily.

  3. Step 3

    Medication administration

    If assigned to the sedation group, the infant receives propofol intravenously. Propofol is an emulsion for injection or infusion, used to help the infant relax during the procedure.

    If the infant does not achieve adequate comfort, as assessed by the Faceless Acute Neonatal Scale (FANS), additional medication such as ketamine may be administered. Ketamine is a solution for injection used as a rescue medication.

  4. Step 4

    Monitoring and assessment

    The infant is monitored for the need for mechanical ventilation (MV) within the first 72 hours of life. This is a primary measure of the trial's success.

    Secondary assessments include evaluating the infant's comfort using the FANS, which measures behavioral and physiological responses, and monitoring for any adverse effects or complications.

  5. Step 5

    Follow-up and evaluation

    The infant's health is assessed for conditions such as bronchopulmonary dysplasia (BPD) at 36 weeks of gestational age.

    Long-term follow-up includes evaluating developmental milestones at two years of age using tools like the ASQ questionnaire and assessing motor, visual, and hearing functions.

Who can join the trial?

9 criteria

  • Preterm infants born less than 32 weeks of gestational age.
  • Infants showing signs of Respiratory Distress Syndrome (RDS) within the first 48 hours of life.
  • Infants treated with CPAP (Continuous Positive Airway Pressure) or BiPAP (Bilevel Positive Airway Pressure).
  • Infants requiring a medication called surfactant to help their lungs function better.
  • Infants with an oxygen level (FiO2) of 30% or more for at least 10 minutes if they are 28-31 weeks of gestational age, or 25% or more for at least 10 minutes if they are less than 28 weeks of gestational age.
  • Infants with a blood oxygen saturation level (SpO2) between 88% and 95%.
  • Infants with an available intra-venous line (a tube placed in a vein for giving medications or fluids), which can be peripheral, umbilical, or central.
  • Infants covered by French Social Security.
  • Parents or guardians must sign an informed consent form agreeing to the infant's participation in the study.

Who cannot join the trial?

8 criteria

  • Babies born at or after 32 weeks of pregnancy cannot participate.
  • Babies who do not have Respiratory Distress Syndrome (a breathing problem) cannot participate.
  • Babies who need immediate mechanical ventilation (a machine to help them breathe) cannot participate.
  • Babies with severe congenital malformations (serious birth defects) cannot participate.
  • Babies with a known allergy to propofol (a type of medicine used for sedation) cannot participate.
  • Babies who have received sedative or analgesic drugs (medicines to calm or relieve pain) before the procedure cannot participate.
  • Babies with a history of severe bradycardia (very slow heart rate) cannot participate.
  • Babies with severe hypotension (very low blood pressure) cannot participate.
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Investigated drugs

Propofol is a medication used to help relax and sedate patients. In this clinical trial, it is being used to see if it can make a procedure called LISA (Less Invasive Surfactant Administration) more comfortable for preterm babies. The trial is comparing the effects of using propofol for sedation versus not using any sedation during this procedure. The goal is to find out if using propofol helps reduce the need for mechanical ventilation within the first 72 hours of life for these babies.

What is already known about the treatment

Propofol – Propofol is administered intravenously, meaning it is given through a vein, and is used in this clinical trial to sedate preterm babies during a procedure called LISA, which stands for Less Invasive Surfactant Administration. Currently, propofol is well-established in medical literature as a sedative and anesthetic agent, commonly used in various medical procedures to help patients relax or sleep. In this trial, its main therapeutic indication is to provide sedation for preterm babies undergoing the LISA procedure to treat Respiratory Distress Syndrome. At the molecular level, propofol works by enhancing the activity of a neurotransmitter in the brain called GABA, which helps to calm the nervous system. It is classified pharmacologically as a general anesthetic.

Investigated diseases

Respiratory Distress Syndrome of preterm infants – This condition occurs in babies born before 32 weeks of gestation due to immature lungs. The lungs lack a substance called surfactant, which helps keep the air sacs open. Without enough surfactant, the air sacs collapse, making it difficult for the baby to breathe. The condition typically presents shortly after birth with rapid, shallow breathing and a grunting sound. As the syndrome progresses, the baby may require additional oxygen or mechanical ventilation to assist with breathing. Over time, the baby's lungs may develop and produce more surfactant, leading to improvement in breathing.
Trial detailsLast updated 2 Oct 2026
Age0-17PhasePhase IIITrial ID2024-518836-36-00Protocol code38RC18.123Estimated enrolment542 patientsSponsorCentre Hospitalier Universitaire Grenoble Alpes

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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