Study on prevention of respiratory consequences related to bronchiolitis caused by respiratory sincizial virus (RSV) in preterm babies

Randomized, multicenter, open-label study on PREvention of respiratory SEquelae of RSV bronchiolitis in preterm babies (PRESERV) - Prevention of respiratory consequences due to viral bronchiolitis in preterm babies

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-002980-25-IT

Enrollment

760

Registered

2020-10-07

Start date

2020-06-12

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory sincizial virus (RSV) bronchiolitis MedDRA version: 21.1 Level: PT Classification code 10038718 Term: Respiratory syncytial virus bronchiolitis System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: palivizumab Product Code: [non disponibile] Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: palivizumab CAS Number: 188039-54-5 Current Sponsor co

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Otherwise healthy (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. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - 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 Bronchopulmonary Dysplasia, children with neuromuscular 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, or to other humanized monoclonal antibodies.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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).;Secondary Objective: To evaluate the difference of RSV-related hospitalization due to low respiratory tract infection during the first RSV-season (November 1st - March31th) between Group A and Group B To evaluate direct and indirect costs related to respiratory sequelae in both groups. The following information for an accurate cost evaluation will be collected: length of hospitalizations; need for Mechanical Ventilation and other support therapies; Intensive Care Unit admission and length of stay; medical specialistic visits; drugs (type, dosages and therapy duration); diagnostic exams, loss of working days for parents due to child illness.;Primary end point(s): Overall respiratory morbidity (composite primary endpoint), whose definition is: a) LRTIs by any pathogen (including, but not limited to, RSV) + b) recurrent wheezing (quantified as presence of wheezing days and/or need for use of antiwheezing drugs) +/- asthma;Timepoint(s) of evaluation of this end point: 18 months	—

Measure

Time frame

Main Objective: 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).;Secondary Objective: To evaluate the difference of RSV-related hospitalization due to low respiratory tract infection during the first RSV-season (November 1st - March31th) between Group A and Group B To evaluate direct and indirect costs related to respiratory sequelae in both groups. The following information for an accurate cost evaluation will be collected: length of hospitalizations; need for Mechanical Ventilation and other support therapies; Intensive Care Unit admission and length of stay; medical specialistic visits; drugs (type, dosages and therapy duration); diagnostic exams, loss of working days for parents due to child illness.;Primary end point(s): Overall respiratory morbidity (composite primary endpoint), whose definition is: a) LRTIs by any pathogen (including, but not limited to, RSV) + b) recurrent wheezing (quantified as presence of wheezing days and/or need for use of antiwheezing drugs) +/- asthma;Timepoint(s) of evaluation of this end point: 18 months

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Secondary

Measure	Time frame
Secondary end point(s): Difference of RSV-related hospitalization due to low respiratory tract infection during the first RSV-season (November 1st - March31th) between Group A (treated with palivizumab) and Group B (not treated).; Direct costs in terms of difference of health resources used by Group A and Group B respectively and related to: a. length of hospitalizations (days); b. mechanical ventilation and other support therapies (type, number, duration); c. Intensive Care Unit admission and length of stay (days); d. outpatient visits (type and number of specialistic visits); f. drugs (type, dosages and therapy duration); g. diagnostic tests (type and number). Costs for resources used will be calculated using National Health Service tariffs.; Indirect costs in terms of loss of working days for parents due to child illness.;Timepoint(s) of evaluation of this end point: 18 months; 18 months; 18 months	—

Measure

Time frame

Secondary end point(s): Difference of RSV-related hospitalization due to low respiratory tract infection during the first RSV-season (November 1st - March31th) between Group A (treated with palivizumab) and Group B (not treated).; Direct costs in terms of difference of health resources used by Group A and Group B respectively and related to: a. length of hospitalizations (days); b. mechanical ventilation and other support therapies (type, number, duration); c. Intensive Care Unit admission and length of stay (days); d. outpatient visits (type and number of specialistic visits); f. drugs (type, dosages and therapy duration); g. diagnostic tests (type and number). Costs for resources used will be calculated using National Health Service tariffs.; Indirect costs in terms of loss of working days for parents due to child illness.;Timepoint(s) of evaluation of this end point: 18 months; 18 months; 18 months

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Countries

Italy

Contacts

Public ContactDipartimento Materno Infantile

Ospedale degli Infermi di Ponderano (Biella)

paolo.manzoni@aslbi.piemonte.it01515156905

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026