An Oligo-center Observational Study to Collect Data in Preterm Neonates Born at or Above 27+0 Weeks of Gestational Age Who Are Sufficiently Stable on Non-Invasive Ventilatory Support
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 主要终点
- Time and failure-adjusted Area Under the Curve (AUC) from Time 0 (T0) to 98 hours after T0 (T47) (AUCT0-T47adjusted) of fraction of inspired oxygen (FiO2)
研究概览
简要总结
The purpose of this observational study is to collect data on vital signs, oxygen requirements and other data related to ventilator care in preterm neonates under standard of care treatment.
详细描述
The objective of this study is to collect data on vital signs, oxygen requirements and other data in preterm infants who are breathing stably on non-invasive ventilatory support. The data obtained during this study will be used to compare data obtained in a future study that will add a new medicinal product in combination with non-invasive ventilatory support to accelerate lung development in preterm infants.
The study will enroll approximately 40 patients. Participants will not be receiving any investigational medicinal product or device in this study.
All participants will have vital signs, oxygen requirements and other data collected continuously throughout the study.
This multi-centre trial will be conducted in Germany. The overall time to participate in this study is up to 10 weeks. Participants will be observed until they reach 36 weeks of gestational age or until they are discharged from the hospital.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 27 Weeks 至 36 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written, informed consent of both parents or legal guardian(s) obtained (on admission, prior to or after delivery).
- •Preterm neonates born at or above 27+0 gestational weeks (GW) who are sufficiently stable on nasal continuous positive airway pressure (CPAP). Upper limit 36+0 GW.
- •Participants' minimum weight at birth must be 800 g. Upper weight limit is 2500 g.
- •CPAP-positive end-expiratory pressure (PEEP) must be ≥5 cm and ≤ 8 cm H2O.
- •Fraction of oxygen (O2) in ventilator outlet gas flow (FiO2) ≥ 30% to reach saturation goal (SpO2 between 88% and 96%) during the time period from B0 to T0.
排除标准
- •FiO2 > 50% to reach saturation goal (saturation of peripheral oxygen (SpO2) between 88% and 96%) during the time period from 30 minutes after birth (B0) to 45 minutes after birth (T0).
- •Presence of severe respiratory distress syndrome (RDS) necessitating immediate intubation and surfactant rescue at entry into the study, or having necessitated surfactant rescue prior to entry into the study.
- •Known life-threatening congenital anomaly or genetic syndrome.
- •Participation in an interventional study in parallel to this observational study.
结局指标
主要结局
Time and failure-adjusted Area Under the Curve (AUC) from Time 0 (T0) to 98 hours after T0 (T47) (AUCT0-T47adjusted) of fraction of inspired oxygen (FiO2)
时间窗: Beginning of the Intensive observation phase (T0; approximately 45 minutes after birth) to 98 hours after T0
Fraction of inspired oxygen (FiO2) is the amount of oxygen in the ventilator outlet gas flow.
次要结局
- Continuous positive airway pressure (CPAP)-failure necessitating intubation and mechanical ventillation and/or surfactant instillation during observation period from T0 to 98 hours(T0 to 98 hours)
- Percentage of participants requiring instillation of an approved surfactant preparation(Gestational week (GW) 36+6 days)
- Mortality rate(T0 to Gestational Week 36+6 days)
- Time of additional oxygen demand (FiO2 > 21%)(T0 to Gestational Week 36+6 days)
- Time with optimal saturation of peripheral oxygen (SpO2) of 88% to 96%(T0 and at 0.25, 0.5, 0.75 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75 4, 4.25. 4.5, 4.74, 5, 5.25, 5.75, 6, 10, 14, 18, 22, 26, 30, 34, 38, 42, 46, 50, and 54 hours)
- Time under Continuous Positive Airway Pressure ventilatory support(T0 to Gestational Week 36+6 days)
- Time on any ventilation support(T0 to Gestational Week 36+6 days)
- Percentage of participants with bronchopulmonary dysplasia (BPD) at GW 36(Gestational Week 36)
- Respiratory rate over time(T0 to Gestational Week 36)
- Percentage of participants with a positive room-air challenge test at Gestational Week 36(Gestational Week 36)
- Time in neonatal intensive care unit (NICU) or intermediate care unit (IMCU)(T0 to Gestational Week 36+6 days)
- Time of intubation for mechanical ventilation(T0 to Gestational Week 36+6 days)
- Days in hospital(From T0 to Gestational Week 36+6 days)