Observational Program to Assess Respiratory Syncytial Virus (RSV) Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis

Study Overview
=================
Brief Summary
-----------------
This was a non-interventional, prospective, multi-center study with no control group designed to assess the effectiveness of palivizumab in a population of infants at high-risk of serious Respiratory Syncytial Virus (RSV) illness (infants born ≤ 35 weeks of gestation and infants ≤24 months with Bronchopulmonary Dysplasia (BPD) or Congenital Heart Disease (CHD)). Participants received immunoprophylaxis during the RSV season, defined as October 2014 through April 2015, in routine clinical settings throughout the Russian Federation.

Detailed Description
-----------------
Participants received intramuscular injections of palivizumab according to physicians' prescription and the local label. The local label recommended 1 month injection intervals between 5 sequential injections at a dose of 15 mg/kg. Participants could have received from 3 to 5 monthly injections of palivizumab during the 2014 - 2015 RSV season and the duration of this study.

Official Title
-----------------
Prospective, Multi-Center, Observational Program to Assess RSV Hospitalization Rate in Population of Children at High-risk of Serious RSV Illness Who Received Palivizumab Immunoprophylaxis in Routine Clinical Setting in the Russian Federation

Conditions
-----------------
Respiratory Syncytial Virus (RSV)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned prescription of palivizumab for immunoprophylaxis during RSV season or participants for whom palivizumab was prescribed and who received the first dose of palivizumab no later than 60 days before enrollment in the study Infants at high risk of severe RSV infection defined as fulfilling at least one of the following: Infants born ≤35 weeks gestational age AND are ≤6 months of age at the onset of the RSV season; Infants ≤24 months of age AND with a diagnosis of BPD (defined as oxygen requirement at a corrected gestational age of 36 weeks); Infants ≤24 months of age with hemodynamically significant CHD, unoperated or partially corrected. Written authorization to use individual data signed by parents or child representative Exclusion Criteria: Major congenital malformation aside from CHD Chronic pulmonary disease other than BPD Acute period of any infection Contraindication to palivizumab prescription according to local label Administration of a product possibly containing RSV-neutralizing antibody within 30 days prior to enrollment or current administration (includes, but is not restricted to, the following: RSV hyperimmunoglobulin, polyclonal intravenous immunoglobulin, cytomegalovirus hyperimmunoglobulin, varicella zoster hyperimmunoglobulin)

Ages Eligible for Study
-----------------
Maximum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Infants at high-risk of serious RSV illness<br>Infants who received immunoprophylaxis during the RSV season | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test | Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits. | Approximately 7 months | 
| Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection | Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests. | Approximately 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test | The duration of hospitalizations due to LRTI which were accompanied by a positive RSV diagnostic test was documented. | Approximately 7 months | 
| Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants | The number of hospitalized participants admitted to the Intensive Care Unit was documented. | Approximately 7 months | 
| Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU) | The median length of stay of hospitalized participants in the Intensive Care Unit was calculated. | Approximately 7 months | 
| Proportion of Participants Who Received Supplemental Oxygen While Hospitalized | The proportion of participants who received supplemental oxygen while hospitalized was documented. | Approximately 7 months | 
| Proportion of Participants Who Received Mechanical Ventilation While Hospitalized | The proportion of participants who received mechanical ventilation while hospitalized was documented. | Approximately 7 months | 
| Proportion of Participants With Missed Doses of Palivizumab | The proportion of participants with missed or delayed doses of palivizumab was documented. | Approximately 7 months | 
| Proportion of Participants With Co-morbidities During Hospitalizations | The proportion of participants with co-morbidities during hospitalizations was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10). | Approximately 7 months | 
| Median Duration of Mechanical Ventilation Administration During Hospitalizations | The median duration of mechanical ventilation administration during hospitalizations was calculated. | Approximately 7 months | 
| Median Duration of Oxygen Administration During Hospitalizations | The median duration of mechanical oxygen administration during hospitalizations was calculated. | Approximately 7 months | 
| Proportion of Participants With a Particular Co-morbidity | The proportion of participants with co-morbidities was documented. Co-morbidities were defined by the International Statistical Classification of Diseases 10 revision (ICD-10). | Approximately 7 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunoprophylaxis, Palivizumab