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Study on Preventing Respiratory Issues from RSV Bronchiolitis in Preterm Babies Using Palivizumab

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 Respiratory Syncytial Virus (RSV) bronchiolitis, which affects the lungs and breathing passages, particularly in young children. The trial is investigating the use of a treatment called palivizumab, marketed under the name Synagis, which is given as a solution for injection. This treatment is being tested to see if it can help prevent respiratory problems in preterm babies who are otherwise healthy.

The purpose of the study is to compare the health outcomes of preterm babies who receive palivizumab with those who do not. The study involves two groups of infants: one group will receive the treatment, and the other will not. The researchers aim to see if the treatment can reduce the number of respiratory issues, such as infections and wheezing, during the RSV season, which typically runs from November to March.

Throughout the study, the health of the infants will be monitored to track any respiratory problems and hospital visits. The study will also look at the costs associated with healthcare resources used by both groups, including hospital stays and treatments. The trial is expected to continue until June 2025, providing valuable information on the effectiveness of palivizumab in preventing respiratory issues in preterm infants.

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 study

    The study involves preterm infants born between 29 and 35 weeks of gestational age. Infants must be younger than 6 months at the start of the RSV season, which begins on November 1st.

    Written informed consent must be obtained from the parents or legal guardians before participation.

  2. Step 2

    Group assignment

    Participants are randomly assigned to one of two groups: Group A or Group B.

    Group A will receive prophylaxis with palivizumab, a medication given to help prevent respiratory infections caused by the respiratory syncytial virus (RSV).

    Group B will not receive the prophylaxis with palivizumab.

  3. Step 3

    Medication administration

    For infants in Group A, palivizumab is administered as an injection. The product used is Synagis 50 mg/0.5 ml solution for injection.

    The medication is given as a solution for injection, following the prescribed dosage and schedule determined by the study protocol.

  4. Step 4

    Monitoring and follow-up

    Participants are monitored for respiratory health throughout the RSV season, which lasts from November 1st to March 31st.

    The primary focus is on overall respiratory health, including any lower respiratory tract infections and recurrent wheezing.

    Secondary observations include the number of hospitalizations related to RSV, healthcare resource usage, and any indirect costs such as loss of working days for parents due to child illness.

  5. Step 5

    Completion of the study

    The study is expected to conclude by June 29, 2025.

    Data collected will be used to compare the health outcomes of infants in Group A and Group B, focusing on the prevention of respiratory issues related to RSV.

Who can join the trial?

5 criteria

  • The baby must be born early, between 29 weeks and 35 weeks and 6 days of pregnancy.
  • The baby should be generally healthy and not have any major health problems related to being born early.
  • The baby must be younger than 6 months old at the start of the **RSV season**, which begins on November 1st. **RSV season** is a time of year when a virus called **Respiratory Syncytial Virus** is more common.
  • Parents or legal guardians must provide written permission for the baby to participate in the study.
  • Both male and female babies can participate in the study.

Who cannot join the trial?

4 criteria

  • Babies who have any major health problems related to being born early cannot participate.
  • Babies who are not in the age range of 29 weeks and 0 days to 35 weeks and 6 days of gestational age cannot participate.
  • Babies who have been exposed to a medication called palivizumab for preventing respiratory infections cannot participate in one of the study groups.
  • Babies who have not been exposed to palivizumab cannot participate in the other study group.
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Investigated drugs

Palivizumab is a medication used in this clinical trial to help prevent serious respiratory infections caused by the respiratory syncytial virus (RSV) in preterm babies. It is given to infants who are at a higher risk of developing severe RSV infections due to their premature birth. The trial aims to see if using palivizumab can reduce the number of respiratory problems these babies might experience.

What is already known about the treatment

Palivizumab – This medication is administered as an injection, typically given into a muscle. It is currently used in medical practice and literature as a preventive treatment for respiratory syncytial virus (RSV) infections, particularly in high-risk infants such as those born prematurely. Palivizumab works by binding to a protein on the surface of the RSV virus, preventing it from entering and infecting healthy cells. It is classified as a monoclonal antibody, which is a type of medication designed to target specific proteins in the body.

Investigated diseases

Respiratory Syncytial Virus (RSV) Bronchiolitis – This is a common lung infection in young children and infants, caused by the respiratory syncytial virus. It primarily affects the small airways in the lungs, leading to inflammation and congestion. Symptoms often start with a runny nose and cough, progressing to wheezing and difficulty breathing. The disease is most prevalent during the winter months and can lead to severe respiratory issues in infants, especially those born prematurely. As the infection progresses, it may cause increased respiratory effort and require medical attention. Recovery can take several weeks, with symptoms gradually improving over time.
Trial detailsLast updated 7 Oct 2026
Age0-17PhasePhase IIITrial ID2024-515418-41-00Protocol codePRESERVEstimated enrolment760 patientsSponsorAzienda Sanitaria Locale Della Provincia Di Biella

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