Comparing Regional Ventilation in Neonates With Different Delivery Systems of Continuous Positive Airway Pressure
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- change in electrical impedance
研究概览
简要总结
The goal of this clinical trial is to compare late preterm newborn lung physiology when supported with different continuous positive airway pressure (CPAP) devices.
The main questions it aims to answer are:
- Which CPAP modality provides better breathing support in newborns with respiratory distress syndrome who are greater than 32 weeks gestational age?
- Does the lung physiology data predict the CPAP modality that will result in a shorter CPAP treatment duration?
Participants will wear a belt of electrodes on their chest (electrical impedance tomography) and have an esophageal balloon manometry measure lung physiology data for 2.5 hours while switching CPAP devices. Participants will then be randomly assigned to a CPAP device to support their breathing until they recover from respiratory distress syndrome.
详细描述
Across centers, there is a variation in standard of care for the preferred device and interface to deliver continuous positive airway pressure (CPAP) to support neonatal functional residual capacity. CPAP, a type of noninvasive respiratory support, is commonly delivered to neonates by mechanical ventilators or underwater bubble devices (bubble CPAP). Variation also exists with the tubing used to deliver CPAP. One commonly used nasal interface is the RAM cannula (Neotech, Valencia, CA), made of a soft material with thin tubing walls and is designed to provide 60-80% occlusion of the nares. This contrasts with the occlusive interface intended to provide complete seal.
To provide evidence for standardization of CPAP delivery, clinical trials are needed to assess which modality of CPAP delivery is optimal for neonates with respiratory distress syndrome who are > 32 weeks and <37 weeks gestational age, an understudied population. The investigators propose to use electrical impedance tomography (EIT) paired with esophageal balloon manometry to assess neonatal lung physiology when supported with different modalities of CPAP. Furthermore, participants will be randomly assigned to A) physiology based CPAP vs B) one size fits all approach. The subjects will remain on the assigned modality of CPAP for the remainder of their respiratory distress syndrome treatment, and researchers will track which modality of CPAP results in a shorter CPAP treatment period and if this is expected based on the lung physiology data collected.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
Given the nature of CPAP, it is not possible to mask which CPAP device the subject is supported by, but the participant, care provider, and outcomes assessor will be masked to whether the subject was randomized to arm A (the device the lung physiology assessment deemed superior for that subject) or arm B (random assignment to the CPAP device, not taking into account the subject's lung physiology).
入排标准
- 年龄范围
- 12 Hours 至 36 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •medically stable neonates born >32 0/7 weeks and < 37 0/7 weeks gestational age, with birth weights > 1500 grams, are chronologically 12-36 hours old, and are receiving RAM cannula ventilator CPAP with positive end expiratory pressure (PEEP) between 5-6 cm water (H2O) and Fraction of inspired oxygen (FiO2) < 0.3 for the suspected diagnosis of respiratory distress syndrome
排除标准
- •neonates with congenital anomalies that potentially will affect respiratory physiology, for example hypoplastic lungs or gastroschisis.
- •neonates with contraindications for wearing an occlusive interface, for example epidermolysis bullosa which may have risk of worsening skin integrity at the pressure points of the occlusive interface, or a known small air leak that may potentially develop into a large pneumothorax.
- •neonates with contraindications for placement of esophageal balloon manometry, for example hypoglycemia managed with extended feeding times greater than 30 minutes.
- •neonates with contraindications for electrical impedance tomography, for example inability to ensure contact of the electrodes on the belt with the skin on the circumference of the chest due to presence of a chest tube dressing.
结局指标
主要结局
change in electrical impedance
时间窗: 2.5 hours during the lung physiology assessment
change in average electrical impedance with each CPAP delivery modality
duration of CPAP treatment
时间窗: through study completion, an average of 2 weeks after the lung physiology assessment
compare groups Arm A-1, A-2 vs Arm B-1, B2; Compare groups Arm A-1, B-1 vs Arm A-2, B-2
次要结局
- lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) vascular pulsatility(2.5 hours during the lung physiology assessment)
- lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in minute ventilation(2.5 hours during the lung physiology assessment)
- lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in end expiratory lung impedance(2.5 hours during the lung physiology assessment)
- lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Abdominal circumference(2.5 hours during the lung physiology assessment)
- lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) end expiratory pressure(2.5 hours during the lung physiology assessment)
- lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) tidal volume(2.5 hours during the lung physiology assessment)
- lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Respiratory rate(2.5 hours during the lung physiology assessment)
- lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) pressure rate product(2.5 hours during the lung physiology assessment)
- lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Oxygen saturation(2.5 hours during the lung physiology assessment)
- lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in dynamic compliance(2.5 hours during the lung physiology assessment)
- lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) esophageal pressure change(2.5 hours during the lung physiology assessment)
- clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) Frequency of deviation(through study completion, an average of 2 weeks after the lung physiology assessment)
- clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial)(through study completion, an average of 2 weeks after the lung physiology assessment)
- clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) frequency of exogenous surfactant administration(through study completion, an average of 2 weeks after the lung physiology assessment)
研究者
Jessica E Shui, MD
Neonatologist, Assistant Professor of Pediatrics at MGH
Massachusetts General Hospital