Continued Pressure for Alveolar Protection: A Randomized Controlled Trial (CPAP Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 860
- 试验地点
- 15
- 主要终点
- Bronchopulmonary Dysplasia or Death
研究概览
简要总结
The objective of the CPAP Trial is to test whether extending CPAP until 34 weeks' PMA or for at least 2 additional weeks compared to weaning to a nasal canula will decrease the likelihood of bronchopulmonary dysplasia or death at 36 weeks' PMA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
The inherent nature of ventilator/respiratory support interventions often precludes the ability to blind investigators and caregivers. As such, many studies in this domain face the limitation of not being blinded. The study team recognizes this limitation and will implement measures to mitigate potential biases arising from an unblinded trial. The DCC PI who will be overseeing the statistical team will be masked. Additionally, interim analysis (efficacy and safety) reports presented to the Data and Safety Monitoring Board (DSMB) will be masked.
入排标准
- 年龄范围
- — 至 31 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age <29 weeks at birth
- •PMA <32 weeks at study entry
- •On treatment with CPAP without a rate in FiO2 <0.25 and PEEP of 4-5 cmH2O
- •Meet stability criteria:
- •If previously intubated must be extubated ≥ 72 hours
- •<3 self-resolving apneas (≤ 20 s) and/or bradycardia (<100 bpm) in any hour over previous 6 hours
- •No episodes of apnea or bradycardia requiring intervention (oxygen/stimulation/bag and mask) for 24 hours
- •Parents/legal guardians consent for enrollment
排除标准
- •Major malformation
- •Neuromuscular condition that affects respiration
- •Terminal illness
- •Decision to withhold or limit support
- •Too sick to participate in opinion of Attending physician
- •Clinical shock, sepsis
- •Planned surgery during study period
研究组 & 干预措施
Continuous Positive Airway Pressure
CPAP will be provided via mask or binasal prongs to maintain a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery whenever available.
干预措施: CPAP (Device)
Nasal Cannula
HFNC at 4 L/min will be used initially in the control group. Flow should be titrated down by 1 L/min per day until ≤0.5 L/kg among infants in the nasal cannula group if not meeting pre-specified failure criteria to reduce the risk of inadvertent positive end-expiratory pressure (PEEP). Flow can also be increased (up to 6 L/min maximum) if needed among infants on NC who meet the pre-specified failure criteria. Infants in the control group placed back on CPAP may use an interface at provider discretion.
干预措施: Nasal Cannula (Device)
结局指标
主要结局
Bronchopulmonary Dysplasia or Death
时间窗: 36 Weeks' PMA
The likelihood of BPD or death at 36 weeks' Postmenstrual Age (PMA): a five-level ordinal outcome (death, survival with grade 3 BPD, survival with grade 2 BPD, survival with grade 1 BPD, and survival free of any BPD).
次要结局
- Days alive and off respiratory support(34-40 weeks' PMA)
- Mortality at 36 Weeks(36 Weeks' PMA)
- Death or Grade 2-3 BPD(36 Weeks' PMA)
- Death or Grade 3 BPD(36 Weeks' PMA)
- Retinopathy of prematurity(52 weeks' PMA)
- Respiratory support, supplemental oxygen, and pulmonary medications(40 weeks' PMA)
- Full PO feedings(52 weeks' PMA)
- Length of hospitalization(52 Weeks' PMA)