A Prospective Randomized Controlled Tiral Comparing Sprinting Versus Non-sprinting Approach to Wean Nasal Continous Positive Airway Pressure Support in Premature Infants Born at Less Than 30 Weeks Gestational Age
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 主要终点
- Number of Participants With Successful Wean Off CPAP at the First Attempt
研究概览
简要总结
Though Nasal Continuous Positive Airway Pressure (NCPAP) is a commonly used form of non-invasive neonatal respiratory support, the optimal method of weaning off NCPAP is not well established. In this prospective, two-center randomized control trial we hypothesize that gradually increasing time off NCPAP (sprinting) increases the success of weaning NCPAP off in infants born between 23 0/7-30 6/7 weeks of gestational age.
详细描述
Eligible infants admitted to two Neonatal Intensive Care Units (NICUs) were randomized to a sprinting (SP) vs. a non-sprinting (NSP) protocol, both over 4 days. Infants assigned to the SP group sprinted twice daily for 3h (day 1), 6h (day 2), 9h (day 3) & then 24h back on NCPAP (day 4) before switching to nasal cannula (NC) on day 5. Infants in the NSP group were maintained on NCPAP of 5 cm of water for the first 4 days before switching to NC on day 5, similar to the SP group. Infants in both groups were observed for the next 3 days (day 5-7) to ensure stability off CPAP
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 26 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born between 23 0/7 - 30 6/7 weeks GA
- •At least 26 0/7 weeks corrected GA.
- •On NCPAP for at least 24 hours
- •Stable on ≤0.3 FiO2 for at least 24 hours
- •Initiation of study protocol, i.e., weaning from NCPAP, was started when infant met all of the following criteria for at least 24 hours:
- •Requiring NCPAP of 4-6 cm of H2O and FiO2 ≤0.
- •All babies < 32 weeks corrected GA should have been loaded or already on maintenance caffeine (caffeine citrate 20 mg/kg as the loading and 5-10 mg/kg as the maintenance dose).
- •Stable respiratory system assessment (respiratory rate of < 70/min, no significant chest retractions (sternal/ diaphragmatic), and baseline oxygen saturation > 86%) and otherwise deemed clinically stable for weaning off non-invasive ventilation by medical team
- •If post-surgery, infant must be at least 2 weeks post-operative and off antibiotics with no concern or need for repeat surgery.
- •A documented hemoglobin of more than 8 g/dl within 7 days of initiation of the study.
- •Meeting "stability criteria" defined below:
- •The infant had to be tolerating a flow of no more than 2 liters NC on a FiO2 of 0.30 or less to keep oxygen saturations above 85% (should match what you wrote below in failure criteria)%.
- •Have a respiratory rate of less than 70 on average over 24 hours for more than 24 hours
- •The infant could have no significant chest recession (sternal/diaphragmatic)
排除标准
- •Evidence of a hemodynamically or clinically significant (worsening respiratory status or pulmonary edema on chest x-ray) Patent ductus arteriosus, diagnosed either clinically or echocardiographically.
- •Any significant congenital abnormality (abnormalities affecting a major organ system, airway, or musculoskeletal system).
- •Hemodynamic/respiratory instability or currently being treated for suspected or proven sepsis (positive blood culture)
- •Grade IV intraventricular hemorrhage
- •Inability to obtain informed parental consent
研究组 & 干预措施
Sprinting
Take off NCPAP twice daily for 3hours (day 1), Take off NCPAP twice daily for 6hours (day 2), Take off NCPAP twice daily for 9hours (day 3), Placed back on NCPAP for 24hours (day 4), Switch to nasal cannula at a flow rate of 1.5-2 L/min (day 5)
干预措施: NCPAP (Device)
Non-Sprinting
- If the infant was on NCPAP 6, Infant was weaned down to CPAP 5 for 96 hours. If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
- If the infant was on NCPAP 5, the infant was continued on CPAP 5 for 96 hours If they met stability criteria, then infant was switched to room air (no flow) or no more than 2L NC.
干预措施: NCPAP (Device)
结局指标
主要结局
Number of Participants With Successful Wean Off CPAP at the First Attempt
时间窗: 7 days
Measured by successful wean off CPAP on first attempt, i.e., no NCPAP requirement after 7 days on wean protocol on first attempt.
次要结局
- Number of Participants With Periventricular Leukomalacia (PVL)(1-2 months)
- Length of Stay (Days)(60-108 days)
- Corrected Gestational Age at Time of Discharge/Transfer(36weeks-41weeks)
- Number of Attempts to Wean Off CPAP(Until completely weaned off CPAP)
- Number of Days on Protocol(7-10 days)
- Number of Participants With Bronchopulmonary Dysplasia(1-2 months)
- Number of Participants With Retinopathy of Prematurity (ROP)(1-2 months)
研究者
Virender Rehan, MD
Chair, Department of Neonatology
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center