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Study on prevention of respiratory consequances related to bronchiolotis caused by respiratory sincizial virus (RSV) in preterm babies
EU CTIS ID: 2024-515418-41-00
What this study is testing
To compare the incidence rate of overall respiratory morbidity in otherwise healthy (neonate who does not display any major short-or-long-term morbidity related to prematurity) preterm babies 29 +0 -35+6 wGA exposed to prophylaxis with palivizumab (Group A) vs infants 29+0 - 35+6 wGA NOT exposed to prophylaxis with palivizumab (Group B)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Otherwise healthly (neonate who does not display any major short-or long-term morbidity related to prematurity) preterm infants 29+0 - 35+6 wGA (male and female)
- Younger than 6 months of age at the beginning of the RSV season (November 1st)
- Written IC obtained from parents/legal guardian
You likely can't join if
- Children HIV+
- Children with neoplasia
- Children with a known cardiac anomaly
- Children with Down syndrome
- Children with severe congenital disorders
- Children who had physician-diagnosed wheeze before the start of the RSV season
See the full eligibility criteria
- Otherwise healthly (neonate who does not display any major short-or long-term morbidity related to prematurity) preterm infants 29+0 - 35+6 wGA (male and female)
- Younger than 6 months of age at the beginning of the RSV season (November 1st)
- Written IC obtained from parents/legal guardian
- Children HIV+
- Children with neoplasia
- Children with a known cardiac anomaly
- Children with Down syndrome
- Children with severe congenital disorders
- Children who had physician-diagnosed wheeze before the start of the RSV season
- High risk for severe course of RSV infection: children with Bronshopulmonary Dysplasia, children with neuromuscolar impairment, children with cystic fibrosis, children with diaphragmatic hernia and other severe congenital respiratory disorders
- Documented hypersensitivity to the drug or to any of its excipients, ot to other humanized monoclonal antibodies
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.