Long-Term Safety and Efficacy Outcomes Following Previously Administered Short-Term Treatment With SHP607 in Extremely Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 26
- 试验地点
- 7
- 主要终点
- Number of Hospitalizations
研究概览
简要总结
The purpose of this study is to evaluate long-term safety and efficacy outcomes following previously administered short-term exposure to SHP607, as compared to a standard neonatal care group.
详细描述
In this long-term follow-up study, participants who enrolled in SHP607-202 (NCT03253263) will be followed from 12 months corrected age (CA) through 60 months CA. Participants will not receive any investigational product in 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
- 12 Months 至 24 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who were randomized into Study SHP607-202 (NCT03253263). Participants who were randomized, but did not complete Study SHP607-202 (NCT03253263) must be at least 12 months CA.
- •Written informed consents (and assents, if applicable) must be signed and dated by the participant's parent(s)/legally authorized representative(s) prior to any study-related procedures. The informed consent and any assents for underage parents must be approved by the institutional review board (IRB)/independent ethics committee (IEC).
排除标准
- •Participants are excluded from the study if the participant or participant's parent(s)/legally authorized representative(s) is/are unable to comply with the protocol or is/are unlikely to be available for long-term follow-up as determined by the investigator.
结局指标
主要结局
Number of Hospitalizations
时间窗: 12 months CA through 60 months CA
Number of hospitalizations associated with a respiratory diagnosis will be reported.
Total Number of Days on Home Respiratory Technology use
时间窗: 12 months CA through 60 months CA
Total number of days on home respiratory technology use (for example, home oxygen, continuous positive airway pressure \[CPAP\], tracheostomy) will be reported.
Number of Participants With Adverse Events (AEs)
时间窗: 12 months CA through 60 months CA
An adverse event (AE) is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment.
Number of Emergency Room Visits
时间窗: 12 months CA through 60 months CA
Number of emergency room visits associated with a respiratory diagnosis will be reported.
Incidence of Signs and Symptoms of Respiratory Disease
时间窗: 12 months CA through 60 months CA
Incidence of signs and symptoms of respiratory disease (yes/no) is assessed by recording episodes of wheezing, coughing, and respiratory medication.
Number of Days of Respiratory Medication Use
时间窗: 12 months CA through 60 months CA
Number of days of respiratory medication use (for example, bronchodilators, steroids, leukotriene inhibitors, diuretics) will be reported.
次要结局
- Physical Development as Assessed by Physical Examination(At 12, 24, and 60 months CA)
- Growth Parameters: Height(At 60 months CA)
- Growth Parameters: Body Weight(At 12, 24, and 60 months CA)
- Growth Parameters: Body Length(At 12 and 24 months CA)
- Growth parameters: Head circumference(At 12 and 24 months CA)
- Cognitive Development Quotient Assessed by Kyoto Scale of Psychological Development (KSPD)(At 24 months CA)
- Childhood Behavior Assessed by Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-V)(At 60 months CA)
- Childhood Behavior Assessed by Social Communication Questionnaire (SCQ)(At 60 months CA)
- Number of Participants With Targeted Medical Events and Fatal Serious Adverse Events (SAEs)(12 months CA through 60 months CA)
- Physical Development as Assessed by Neurological Examination for Assessment of Cerebral Palsy(At 12, 24, and 60 months CA)
- Physical Development as Assessed by Visual Acuity(At 12, 24, and 60 months CA)
- Cognitive Development Assessed by Bayley Scales of Infant and Toddler Development (BSID-III)(At 24 months CA)
- Cognitive Development Assessed by Wechsler Preschool and Primary Scale of Intelligence (WPPSI)(At 60 months CA)
- Healthcare Resource Utilization(12 months CA through 60 months CA)
- Childhood Behavior Assessed by Vineland Adaptive Behavior Scales (VABS-III)(At 24 and 60 months CA)
- Health Related Quality of Life (HRQoL) Assessed by the Pediatric Quality of Life Inventory (PedsQL) Scales(At 24, 36, 48, and 60 months CA)
- Gross Motor Function Assessed by Gross Motor Function Measure-88 (GMFM-88)(At 24 and 60 months CA)
- Health Status Measured by the Health Utilities Index 2/3(At 60 months CA)