Effects of Flow Magnitude on Cardiorespiratory Stability During Nasal High Flow Therapy in Preterm Infants (MASTER Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Treatment failure
研究概览
简要总结
Premature babies often need help breathing for a longer period of time. Traditionally, this is done with a breathing aid called NCPAP (nasal continuous positive airway pressure). This treatment is safe and effective, but it is very time-consuming and can sometimes have side effects. In the present research project, the investigators want to find out whether another type of breathing aid called NHF (nasal high flow therapy) is just as effective for stable premature babies. The investigators suspect that NHF is just as effective, but easier to use and more comfortable.
详细描述
This is a multi center parallel group three arm randomized controlled clinical trial investigating cardiorespiratory stability in stable preterm infants receiving NHF.
Currently, NCPAP remains the gold standard for administration of prolonged non-invasive ventilatory support in very preterm infants. NHF is a promising method for tailored, less invasive long-term ventilatory support for preterm infants. If ventilatory support with NHF is similarly effective to conventional NCPAP in stable preterm infants, clinicians are likely to adopt this method for widespread clinical use because of its improved comfort and potential other benefits. Primary aim of this trial is to examine cardiorespiratory stability in preterm infants treated with two commonly used NHF flowrates (Interventional group 1 and 2) in comparison to NCPAP (Comparator). Secondary aim is to examine potential comfort-related beneficial effects of NHF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
盲法说明
Due to the nature of the study design masking is not possible.
入排标准
- 年龄范围
- 23 Weeks 至 31 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion if all apply.
- •Preterm infants up to 31+6 weeks GA admitted to the Division of Neonatology at Inselspital Bern, Switzerland or Division of Neonatology at the University Medical Center of the Johannes Gutenberg-University Mainz, Germany (inborn or outborn)
- •>2nd day of life (defined as date day)
- •Stable on NCPAP 6 cm H2O for ≥ 24 hours, defined as:
- •≤ 2 apneas with concomitant bradycardias (<100/min) per hour for the previous 6 hours
- •FiO2 ≤ 0.3 and not increasing
- •No significant chest recessions (Silverman Score < 5)
- •Respiratory rate ≤ 60/min
- •No need for intermittent positive pressure ventilation
- •Parents with an age 18+ years
- •Written parental informed consent (or other legal representative)
排除标准
- •Exclusion if any applies.
- •Significant fetal anomalies
- •Primary palliative care
- •Stable on NCPAP 6 cm H2O according to stability criteria for more than 120 hours
研究组 & 干预措施
NHF high
Nasal high flow therapy 8L/min
干预措施: NHF high (Other)
NHF low
Nasal high flow therapy 6L/min
干预措施: NHF low (Other)
NCPAP
Nasal continuous positive airway pressure 6 cm H20
干预措施: NCPAP (Other)
结局指标
主要结局
Treatment failure
时间窗: 24 hours
Treatment failure is a composite outcome defined as meeting one of the following treatment failure criteria within 24 hours of starting of intervention: 1. \>2 apneas with concomitant bradycardias (\<100/min) per hour for \> 1 hour or 2. FiO2 \> 0.3 consistently for \> 1 hour or 3. Significant chest recessions (Silverman Score ≥ 5) for \> 1 hour or 4. Respiratory rate \> 60/min consistently for \> 1 hour or 5. Any need for intermittent positive pressure ventilation The presence of "Treatment failure" within 24 hours of starting of intervention will be documented (dichotomous outcome; yes/no).
次要结局
- Apneas and bradycardias(24 hours)
- Respiratory rate (RR)(24 hours)
- Heart rate (HR)(24 hours)
- Oxygen saturation (SpO2) and fraction of inspired oxygen (FiO2)(24 hours)
- Frequency of any treatment failure(Individual study duration: estimated to be between a minimum of 7 days to an (estimated) maximum of 10 weeks.)
- Rescue NCPAP(Individual study duration: estimated to be between 7 days to 10 weeks.)
- Postmenstrual age (PMA) off positive pressure support(Estimated to be at a PMA of approximately 29 to 34 weeks.)
- Postmenstrual age (PMA) off FiO2 > 0.21(Estimated to be at a PMA between approximately 28 to 34 weeks.)
- Postmenstrual age (PMA) at discharge(Estimated to be at a PMA of approximately 38-40 weeks.)
- Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after start of the intervention(4 hours)
- Time spent <55% cRSO2 1 hour before until 3 hours after start of the intervention(4 hours)
- Cerebral oxygen saturation (cRSO2) 1 hour before until 3 hours after cessation of the intervention(4 hours)
- Time spent <55% cRSO2 1 hour before until 3 hours after cessation of the intervention(4 hours)
- Change in end-expiratory lung impedance (ΔEELI)(48 hours)
- Change in global inhomogeneity (ΔGI) index(48 hours)
- Change in variability of tidal volume (ΔTV)(48 hours)
- Change in ratio of tidal volume anterior/posterior (ΔRatio TV ap)(48 hours)
- Incidence of Bronchopulmonary dysplasia (BPD)(At 36 weeks PMA)
- Urinary cortisol(24 hours)
- COMFORTneo score(72 hours)
- Revised Bernese Pain Scale for Neonates (BSN-R) score(72 hours)
- Parental assessment of comfort(72 hours)
- NASA Task Load Index (NASA-TLX)(72 hours)
- Nasal trauma score(Individual study duration: estimated to be between 7 days to 10 weeks.)
- Behavioral Sleep stage classification for Preterm Infants (BeSSPI)(24 hours)
- Parental Bonding Questionnaire (PBQ)(At 36 weeks PMA)
- Age at initiating breastfeeds(Estimated to be between 30-34 weeks PMA.)
- Age at reaching full breastfeeds(Estimated to be between 34-40 weeks PMA.)
- Weight(At 36 weeks PMA)
- Head circumference(At 36 weeks PMA)