PMOS to Evaluate the Compliance to Synagis (Palivizumab) Under Daily Pediatrician´s Conditions in Premature Infants 33 - 35 wGA Over 3 Consecutive Respiratory Syncytial Virus (RSV) Seasons in Austria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 124
- 试验地点
- 45
- 主要终点
- Number of Injections Per Patient Per Season
研究概览
简要总结
Compliance to Synagis (palivizumab) is a key factor to obtain maximal protection against respiratory syncytial virus (RSV) infection as shown in the IMpact study. Many factors such as parents' knowledge of burden of respiratory syncytial virus disease or physicians' satisfaction with Synagis as well as the appropriate use of the product might influence compliance. The primary objective of this observational study is to evaluate the compliance to Synagis under daily pediatricians practice conditions in premature infants 33 to 35 weeks gestational age (wGA). Palivizumab, monoclonal antibody for passive immunoprophylaxis against severe respiratory syncytial virus disease, was administered according to usual clinical practice. Compliance was assessed using four criteria: The number of injections per participant per respiratory syncytial virus season, the body site where injections were administered, the interval in days between injections, and the dosage per administration. Originally the study was to include two respiratory syncytial virus seasons but was extended to a third season.
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 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infant 33 to 35 weeks gestational age
- •Younger than 3 months at respiratory syncytial virus season start
- •At least 4 points according to the Austrian risk score according to Austrian guidelines: 1 point younger than 3 months (at start of respiratory syncytial virus season), 1 point neurologic disease, 1 point weight less than 10th percentile, 1 point discharge from hospital during respiratory syncytial virus season (1 Oct - 30 March), 1 point older siblings, 0.5 points multiple births, 0.5 points day care attendance, 0.5 points passive tobacco smoke exposure, 0.5 points socio-economic status (overcrowding)
- •Synagis application (prescription)
- •Signed authorization form for data use (parental authorization)
排除标准
- •Patients without Synagis prescription
- •Patients who meet contraindications as outlined in the latest version of Synagis summary of product characteristics (SmPC):
- •Patients with known hypersensitivity to palivizumab or any component of the formulation or other humanized monoclonal antibodies
- •Patients with chronic lung disease
- •Patients with congenital heart disease
- •Greater than 36 weeks gestational age
结局指标
主要结局
Number of Injections Per Patient Per Season
时间窗: One RSV season (5 months)
The average number of injections administered per participant within a respiratory syncytial virus season.
Body Site of Injections Per Administration
时间窗: One RSV season (5 months)
The body site of injection administration for participants at each study visit.
Interval Between Administrations
时间窗: One RSV season (5 months)
The average number of days that elapsed between palivizumab injections administered at the previous study visit.
Dosage Per Administration
时间窗: One RSV season (5 months)
The median dose and range of palivizumab (milligrams) that was administered at each study visit.
次要结局
- Parents Knowledge of Burden of RSV Disease Via Interview by Physician(One RSV season (5 months))
- Effectiveness of Palivizumab at the End of the Observation Period is Checked by the Physician by Ranking in a Visible Analog Scale(One RSV season (5 months), end of study)
- Assessment of Pain During Injection According to Pain Scores (VAS and Modified Behavioral Pain Scale)(One RSV season (5 months))