A Randomised Trial of Colorimetric Carbon Dioxide (CO₂) Detector-guided Non-invasive Ventilation Versus Standard Care: The NEU-CAP Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,860
- 主要终点
- Use of positive pressure ventilation (PPV) between 5 and 10 minutes after birth
研究概览
简要总结
The aim of NEU-CAP is to investigate the clinical impact of using a colorimetric carbon dioxide (CO₂) detector during non-invasive ventilation (NIV). Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioural aspect, in this case CO₂-detector-guided non-invasive ventilation.
详细描述
Rationale: Most infants establish effective gas exchange after birth independently with spontaneous breathing. Those that don't, receive breathing support non-invasively either through a face mask or invasively through endotracheal tube (ETT). Endotracheal ventilation is associated with lung injury in preterm infants. As a result, clinicians aim to support premature infants non-invasively and to only intubate those who don't respond adequately to mask positive pressure ventilation (PPV). It is a challenge for clinicians to judge how well infants are breathing and the effect of PPV during face mask breathing support. Current methods of monitoring provide indirect feedback that may be difficult to interpret. Exhaled carbon dioxide (CO₂) detectors that change colour in the presence of CO₂ are used to confirm ETT position. Detection of CO₂ during mask breathing support may offer a direct indication of gas exchange, which might allow for better assessment of spontaneous breathing and ventilation effectiveness.
Objective: To assess the effect of colorimetric CO₂ detector use during non-invasive ventilation, versus standard care, on the proportion of neonates receiving PPV after 5 minutes of life
Study design: This is a stepped-wedge cluster randomised trial, with randomisation occurring at the level of the participating hospital rather than the individual infant. This design is suitable for evaluating interventions with a potential learning effect and supports a structured implementation across study sites.
Study population: Infants receiving non-invasive breathing support in the first 10 minutes of life, born before 32 weeks of gestation.
Intervention: At the start of the study, all participating centres will continue their standard practice by providing non-invasive breathing support without using a CO₂ detector. As the study progresses, centres will switch one-by-one to using the colorimetric CO₂ detector during mask breathing support until all have switched. Once they have switched, centres will continue to use the CO₂ detector until the end of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Centres will be randomised for the fortnight at which they will switch their non-invasive ventilation practice from standard care to CO₂-detector-guided non-invasive ventilation. The analysing researcher will be blinded for the allocation of treatment switch.
入排标准
- 年龄范围
- — 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born before 32 weeks of gestation
- •Received non-humidified face-mask support in the first 10 minutes of life
- •Parental consent obtained
排除标准
- •Congenital diaphragmatic hernia
- •Tracheo-oesophageal fistula
- •Cyanotic heart disease
- •Surfactant protein deficiency
- •Any other congenital abnormality or condition with an adverse effect on breathing, ventilation, or oxygenation. Many of the infants enrolled in the study will later be diagnosed with respiratory distress syndrome (RDS); this will not render them ineligible for inclusion.
研究组 & 干预措施
Standard care
At the start of the study, all participating centres will provide NIV using the standard monitoring methods in place as part of their local standard of care; this will not include using a CO₂ detector at any centre. No additional tools or changes to monitoring protocols will be introduced during this period.
干预措施: Local standard care of monitoring non-invasive ventilation (Procedure)
Colorimetric CO₂-detector-guided non-invasive ventilation
For each centre, a lot will be drawn which indicates the fortnight in which the protocol changes from standard care to CO₂-detector-guided non-invasive ventilation.
Colorimetric CO₂ detectors have a chemical indicator that changes colour when a threshold level of CO₂ is exceeded. They are routinely used in newborn infants to confirm that an endotracheal tube (ETT) is correctly placed in the trachea. The CO₂ detector also has promise as a tool to directly assess lung aeration during mask breathing support. It could offer immediate feedback on both the adequacy of spontaneous breathing during continuous positive airway pressure (CPAP) and the effectiveness of PPV in non-breathing neonates. The colorimetric CO₂ detector used in this study has been developed specifically for use during NIV.
All other procedures in the delivery room and neonatal intensive care unit (NICU) will be performed according to international and local guidelines.
干预措施: CO₂-guided Non-Invasive Ventilation (Procedure)
结局指标
主要结局
Use of positive pressure ventilation (PPV) between 5 and 10 minutes after birth
时间窗: 5-10 minutes after birth
Proportion of infants receiving positive pressure ventilation between 5 and 10 minutes after birth
次要结局
- Use of PPV before 1 minute(Before 1 minute after birth)
- Use of PPV between 1 and 5 minutes(1-5 minutes after birth)
- Use of PPV after 10 minutes(After 10 minutes after birth)
- Heart rate(At 5 minutes after birth)
- Apgar score(1, 5 and 10 minutes after birth)
- Use of PPV <10 min(Within 10 minutes after birth)
- Number of infants who received chest compressions <10min(Within 10 minutes after birth)
- Number of infants who were intubated <10min(Within 10 minutes after birth)
- Number of infants who were administered adrenaline <10min(Within 10 minutes after birth)
- Number of infants who were administered volume expansion <10min(Within 10 minutes after birth)
- Death <10min(Within 10 minutes after birth)
- Number of infants who were supported by continuous positive airway pressure (CPAP) in the first week after birth(In the first week after birth)
- Number of infants who received surfactant in first week(In the first week after birth)
- Surfactant doses(In the first week after birth)
- Number of infants who were mechanically ventilated(In the first week after birth)
- Number of infants with abnormalities on the first cranial ultrasound(In the first week after birth)
- Number of infants who died in the first week after birth(In the first week after birth)
- Cord clamping time(During resuscitation at birth)
研究者
Janneke Dekker
Assistant Professor
Leiden University Medical Center