Respiratory Management Of Extremely Preterm Neonates: Evidence Generation And Implementation By Comparative Effectiveness Research (CER) Using Real World Data (RWD) From A Practice-Based Research Network (PBRN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,829
- 试验地点
- 1
- 主要终点
- Failure on assigned NRS mode within 72 hours post-initial extubation
研究概览
简要总结
Aim: Investigators aim is to conduct two complementary and concurrent CER projects using a pragmatic clinical trial design and registry-based RWD to identify the optimal respiratory management practices for extremely preterm neonates and reduce the risk of BPD and SNI.
Objectives: Two complementary objectives are proposed. Objective 1: To determine the efficacy and safety of "mandatory non-extubation" until 72 hours of postnatal age for preterm neonates born at 23 -25 weeks' GA who receive mechanical ventilation.
Objective 2: To determine whether optimal nasal continuous positive airway pressure post-extubation is as efficacious as nasal intermittent positive pressure ventilation in preterm neonates born at 23 -28 weeks' GA who have received mechanical ventilation.
详细描述
Background and Importance: Preterm neonates <29 weeks' gestational age (GA) have a 10% risk of mortality, 15% risk of severe neurological injury (SNI) and 45% risk of bronchopulmonary dysplasia (BPD). Both SNI and BPD are associated with significant long-term impairment. Various management approaches to prevent these complications are adopted without rigorous evaluation because conducting large-scale randomized trials can be challenging. One area consistently associated with SNI and BPD is respiratory management of these neonates which is also the area lacking evidence-informed approach. Comparative effectiveness research (CER) of different management strategies using Real World Data (RWD) is suggested as an alternative to generate Real World Evidence (RWE). Hypotheses Evaluating Treatment Effectiveness (HETE) studies are a form of CER where two or more practices are compared to evaluate presence or absence of anticipated effect using specific hypothesis. In this proposal, investigators will study two specific respiratory management practices for preterm neonates <29 weeks' GA using this design under the auspices of our practice based research network of the Canadian Preterm Birth Network (CPTBN) which has extensive routine data collection for this population.
Aim: Investigators aim to conduct two complementary and concurrent CER projects using a pragmatic clinical trial design and registry-based RWD to identify the optimal respiratory management practices for extremely preterm neonates and reduce the risk of BPD and SNI.
Objectives: Two complementary objectives are proposed. Objective 1: To determine the efficacy and safety of "mandatory non-extubation" until 72 hours of postnatal age for preterm neonates born at 23 -25 weeks' GA who receive mechanical ventilation.
Objective 2: To determine whether optimal nasal continuous positive airway pressure post-extubation is as efficacious as nasal intermittent positive pressure ventilation in preterm neonates born at 23 -28 weeks' GA who have received mechanical ventilation.
Methods:
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
- 23 Weeks 至 28 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must meet all criteria
- •Preterm neonates <29 weeks gestational age
- •Receipt of mechanical ventilation
排除标准
- •Not received mechanical ventilation or active care
- •Congenital/genetic/chromosomal anomalies
结局指标
主要结局
Failure on assigned NRS mode within 72 hours post-initial extubation
时间窗: 72 hours
* CPAP arm * Switch to any one of: NIPPV (including NIV-NAVA), or NIHFV * Escalation of CPAP PEEP \>12 cmH2O * Intubation * NIPPV arm * Switch to any one of: NIHFV or NIV-NAVA (for centres that use unsynchronized NIPPV as their primary post-extubation mode) * Escalation of NIPPV beyond any one or more of the maximum allowable settings as described earlier * Switch to CPAP with PEEP \> calculated MAP on NIPPV * Intubation
次要结局
- Days of any respiratory support (Post-initial extubation)(through study completion, an average of 14 weeks)
- Need for intubation within 72 hours and 7 days post-initial extubation(72 hours and 7 days)
- Bronchopulmonary dysplasia (BPD) at 36 weeks' PMA(36 weeks post mestrual age)
- Days of EMV (Post-initial extubation)(through study completion, an average of 14 weeks)
- PMA when off positive pressure support(through study completion, an average of 14 weeks)
- Mortality before hospital discharge(through study completion, an average of 14 weeks)
- Failure on assigned NRS mode within 7 days post-initial extubation(7 days)
- Days of non-invasive respiratory support including high flow (Post-initial extubation)(through study completion, an average of 14 weeks)
- Days of supplemental oxygen requirement (Post-initial extubation)(through study completion, an average of 14 weeks)
- Air leak (Post-initial extubation)(through study completion, an average of 14 weeks)
- Chronological age and post-menstrual age at time of full enteral feeds(through study completion, an average of 14 weeks)
研究者
Prakesh Shah
Director
Canadian Neonatal Network