Open Randomised Study of Conventional Ventilation Optimised by Dead Space Washout in Extremely Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 4
- 主要终点
- Cumulative duration of all periods of non-invasive ventilation
研究概览
简要总结
The Continuous Tracheal Gas Insufflation (CTGI) is a ventilation option of conventional mechanical ventilation that is used to reduce or even eliminate the dead space caused by respiratory prostheses. This objective is of particular interest in the smallest preterm infants, where the volume of anatomical dead space due to prostheses is little different from the tidal volume. The principle of this option is to continuously blow an additional flow of 0.2 L/minute at the tip of the endotracheal tube to purge expired CO2 trapped in the prostheses, to have a CO2-free volume of gas available for subsequent insufflation.
The goal of this clinical trial is to learn if Continuous Tracheal Gas Insufflation (CTGI) works to reduce ventilatory dependence in preterm infants after mechanical ventilation. It will also learn about the safety of CTGI. The main questions it aims to answer are:
- Does Continuous Tracheal Gas Insufflation (CTGI) reduce the number of days of non-invasive ventilation in extremely preterm infants who needed mechanical ventilation?
- Does Continuous Tracheal Gas Insufflation (CTGI) reduce the age at the weaning of any ventilatory support and/or oxygen supplementation.
Researchers will compare the clinical outcome of patients mechanically ventilated with the CTGI-device to the outcome of patients ventilated without the CTGI device, to see if the CTGI ventilation works to reduce ventilation dependence.
Participants will:
• Be mechanically ventilated using CTGI (if randomly assigned in the CTGI-group), for the entire endotracheal ventilation period during their stay in the neonatal intensive care unit.
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
- None
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational Age at birth between 23 weeks gestation + 0 days and 26 weeks gestation + 6days
- •Age between 0 and 7 days of life
- •Need for intubation and mechanical ventilation before day 8 of life
- •Availability of the Research-associated medical devices
- •Beneficiary of a social security system (in France: CMU or securité sociale)
- •Parental consent for their infant to participate in this trial
排除标准
- •Known Severe Congenital Malformation (potential life-threatening malformation)
- •Known Preexisting Severe Intraventricular Haemorrhage (grade 3 or 4) and/or other brain abnormality that can alter life prognosis
- •Known Genetic Disorder (potential life-threatening malformation)
- •Preexistent mechanical ventilation for a duration of more than 12 hours
- •Participation in another interventional research trial before inclusion
研究组 & 干预措施
Continuous Tracheal Gas Insufflation
the preterm infant intubated and ventilated with Continuous Tracheal Gas Insufflation
干预措施: Ventilation with Dead Space Washout via Continuous Tracheal Gas Insufflation (CTGI) (Device)
Standard ventilation without CTGI
In the No Intervention arm, the preterm infants are mechanically ventilated using standard ventilation, without the CTGI-device. There is no dead space washout.
结局指标
主要结局
Cumulative duration of all periods of non-invasive ventilation
时间窗: From birth to the end of hospital stay, up to maximum 45 weeks of corrected gestational age.
The cumulative duration of all periods of non-invasive ventilation, in days, starting from birth, and up to maximum 45 weeks corrected gestational age. Non-invasive ventilation includes all types of positive pressure support non-invasive ventilation and high flow nasal cannula ventilation (HFNC).
次要结局
- Number of participant with Severe hypoxemia(From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life)
- Calculation of the mean age at definitive weaning from invasive ventilation for the participants in each arm.(From birth to the date of the end of the hospital stay, up to maximum 5 months of life)
- Age of the participants at definitive O2 weaning.(From birth to the date of the end of the hospital stay, up to maximum 5 months of life)
- Number of participants deceased(From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life)
- Measure of the Driving Pressure during mechanical ventilation(From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life)
- Measure of expiratory tidal volume during mechanical ventilation.(From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life)
- Measure of Transcutaneous Carbon dioxide partial pressure (TcPCO2)(From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life)
- Number of participants who received a second dose of surfactant(From birth up to maximum 7 days of life.)
- Number of participants treated with high-frequency ventilation (HFV) or high-frequency oscillatory ventilation (HFOV).(From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life)
- Third cytokine dosage in tracheal aspirates.(Between day 10 to day 12 of life.)
- Resuts of Neurodevelopmental Follow-up for surviving participants.(At 2 years of corrected age (± 2 months))
- Number of participants with Cerebral Palsy(At 2 years of corrected age (± 2 months))
- Number of participants with visual disorders at 2 years of age(At 2 years of corrected age (± 2 months))
- Number of participants requiring hemodynamic support.(From enrollment in the study to the date of the end of the hospital stay, up to maximum 5 months of life)
- Measure of carbon dioxide partial pressure (PCO2) on blood gas(From enrollment up to maximum 15 days of life)
- Use of Inhaled Nitric Oxide (iNO therapy)(From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life)
- Number of participants treated for Pneumothorax(From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life)
- Number of participants treated with Systemic Corticosteroids for Prevention or Management of Bronchopulmonary Dysplasia (BPD)(From enrollment to the date of the end of the hospital stay, up to maximum 5 months of life)
- Number of participants diagnosed as Bronchopulmonary Dysplasia (BPD)(From two days before 36 weeks of corrected gestational age until two days after 36 weeks of corrected gestational age..)
- Number of participants with unplanned extubation(From birth to the date of the end of the hospital stay, up to maximum 5 months of life)
- Calculation of days with invasive mechanical ventilation for each participant.(From birth to the date of the end of the hospital stay, up to maximum 5 months of life)
- Age of participants at definitive weaning from all positive pressure ventilatory support(From birth to the date of the end of the hospital stay, up to maximum 5 months of life)
- Age of the participants at the definitive withdrawal of any Ventilatory Support(From birth to the date of the end of the hospital stay, up to maximum 5 months of life)
- Number of participants with Late-onset primary bloodstream infections(From birth to the date of the end of the hospital stay, up to maximum 5 months of life)
- Number of participants with Neuroimaging complications(From birth to the date of the end of the hospital stay, up to maximum 5 months of life)
- Number of participants Treated for Retinopathy (ROP)(From birth to the date of the end of the hospital stay, up to maximum 5 months of life)
- Number of days for each participant of Exposure to systemic analgesic or sedatives treatments(From birth to the date of the end of the hospital stay, up to maximum 5 months of life)
- First cytokine dosage in tracheal aspirates.(Between 24 hours to 48 hours of life.)
- Second cytokine dosage in tracheal aspirates.(Between day 4 to day 5 of life.)
- Measurement of average weight gain for all study participants in each arm.(From birth to the date of 36 weeks of corrected gestational age.)
- Number of days for each participant in the study with central venous line(From birth to the date of the end of the hospital stay, up to maximum 5 months of life)
- Number of participants necessitating respiratory drugs during the two first years of life.(From the date of discharge from the hospital to 2 years of age)