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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 359
- 主要终点
- Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Proportion of Infants Hospitalized for Lower Respiratory Tract Infection (LRTI) With a Positive Respiratory Syncytial Virus (RSV) Diagnostic Test
时间窗: Approximately 7 months
Hospitalizations for LRTI with positive RSV diagnostic tests were documented at study visits.
Proportion of Infants Who Died From a Confirmed Respiratory Syncytial Virus (RSV) Infection
时间窗: Approximately 7 months
Deaths caused by RSV during the study were to be confirmed by autopsy or clinical history and positive virologic diagnostic tests.
次要结局
- Median Duration of Mechanical Ventilation Administration During Hospitalizations(Approximately 7 months)
- Median Length of Stay (LOS) of Lower Respiratory Tract Infection (LRTI) Hospitalization With a Positive Respiratory Syncytial Virus (RSV) Test(Approximately 7 months)
- Proportion of Participants With a Particular Co-morbidity(Approximately 7 months)
- Proportion of Participants With Intensive Care Unit (ICU) Admission Among Hospitalized Participants(Approximately 7 months)
- Median Length of Stay (LOS) of Participants in the Intensive Care Unit (ICU)(Approximately 7 months)
- Proportion of Participants With Missed Doses of Palivizumab(Approximately 7 months)
- Proportion of Participants With Co-morbidities During Hospitalizations(Approximately 7 months)
- Proportion of Participants Who Received Supplemental Oxygen While Hospitalized(Approximately 7 months)
- Proportion of Participants Who Received Mechanical Ventilation While Hospitalized(Approximately 7 months)
- Median Duration of Oxygen Administration During Hospitalizations(Approximately 7 months)