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

Conditions

Respiratory sincizial (RSV) bronchiolitis

Brief summary

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

Detailed description

Difference of number of RSV-related hospitalizations due to low respiratory tract infection during the first RSV-season (November 1st- March 31th) between Group A and Group B., Direct costs in terms of difference of health resources used by Group A and Group B respectively and related to: lenght of hospitalizations(days);mechanical ventilation and other support therapies(type, number, duration);Intensive Care Unit admission and lenght of stay(days);outpatient visits(type and number of specialistic visits);drugs(type, dosage and therapy duration);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 due to child illness

Related papers

No related papers found yet.

Interventions

DRUGSynagis 50 mg/0.5 ml solution for injection

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
Difference of number of RSV-related hospitalizations due to low respiratory tract infection during the first RSV-season (November 1st- March 31th) between Group A and Group B., Direct costs in terms of difference of health resources used by Group A and Group B respectively and related to: lenght of hospitalizations(days);mechanical ventilation and other support therapies(type, number, duration);Intensive Care Unit admission and lenght of stay(days);outpatient visits(type and number of specialistic visits);drugs(type, dosage and therapy duration);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 due to child illness	—

Measure

Time frame

Difference of number of RSV-related hospitalizations due to low respiratory tract infection during the first RSV-season (November 1st- March 31th) between Group A and Group B., Direct costs in terms of difference of health resources used by Group A and Group B respectively and related to: lenght of hospitalizations(days);mechanical ventilation and other support therapies(type, number, duration);Intensive Care Unit admission and lenght of stay(days);outpatient visits(type and number of specialistic visits);drugs(type, dosage and therapy duration);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 due to child illness

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Countries

Italy

Outcome results

None listed