Pressure HIgh or LOw DElivered to Preterm Newborns in the Delivery ROOM
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Oxygen saturation/Inspired Oxygen fraction (SpO2/FiO2)
研究概览
简要总结
The aim of this randomized pilot clinical trial of preterm infants requiring noninvasive respiratory support for respiratory distress syndrome (RDS) at birth is to improve short-term respiratory outcomes. The main question it aims to answer is:
- Can a CPAP (or a PEEP if ventilation is needed) administered with a face mask and a T-piece at a level of 8 cmH2O improve lung recruitment in the delivery room when compared to administration of a level of 5 cmH2O in a control group?
- Secondly, can improved lung recruitment in the first few minutes of life provide long-term benefits to the premature infant? The participants will be premature infants between 26 and 29+6 weeks gestational age.
详细描述
BACKGROUND:
It has been widely demonstrated that noninvasive respiratory support (NIV) used in the delivery room can reduce the incidence of pulmonary bronchodysplasia (BPD) and death in very preterm infants weighting less than 1500 g.
In this population, the use of CPAP immediately after birth during the respiratory stabilization in the delivery room has been shown to promote respiratory transition and promote the achievement of an initial adequate functional residual capacity (CFR).
To date, various forms of delivery of additional pressures in the first minutes of life are being studied such as positive pressure ventilation (PPV), sustained inflation (SI), ventilation with dynamic increasing and decreasing levels of CPAP. However, there is no consensus on which pressure is the best and safest to apply and its optimal duration.
This monocentric pilot study aims to verify in preterm infants (26-29+6 weeks EG) the feasibility, efficacy and safety of using two different levels of CPAP (5 vs 8 cmH2O - both of which are contemplated in international guidelines for the management of the premature infant) in the delivery room; it will also test the accuracy and usefulness of the data that can be recorded with an RFM as indices of oxygenation, spontaneous ventilation and therefore of early lung recruitment. The investigators hypothesize that a higher CPAP level (8 cmH2O) for the first 15 minutes of life may lead to faster and more effective lung recruitment.
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 (Participant)
入排标准
- 年龄范围
- 26 Weeks 至 30 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants at birth between 26 and 29+6 weeks gestational age with Respiratory distress syndrome requiring non invasive respiratory support
排除标准
- •Congenital anomalies
研究组 & 干预措施
CPAP 8
Upon arrival of the infant on the neonatal resuscitation trolley, start the normal standard procedures required by international protocols (e.g., drying, temperature control measures, placement of pulse-oximeter sensor to the right hand or wrist, etc.). Immediately start CPAP application with mask and T-piece: the CPAP level will be set at 8 cmH2O. Perform gentle tactile stimulation if the child is not breathing in appropriately. Place the pulse-oximeter sensor on the right hand then connect it to the oxymeter previously turned on. Assess breathing and HR for 30 seconds. Perform the next step of the flow-chart of resuscitation in the delivery room according to the Neonatal Resuscitation Program guidelines. If positive pressure ventilation (PPV) is required (in case of persistent bradycardia or apnea), maintain PEEP at 8 cm H2O and an initial PIP of 25 cm H2O. The CPAP level will be reduced to 6 cm H2O after 15 minutes of life, then the recording will be discontinued.
干预措施: static CPAP 8 cmH2O (Behavioral)
CPAP 5
Upon arrival of the infant on the neonatal resuscitation trolley, start the normal standard procedures required by international protocols (e.g., drying, temperature control measures, placement of pulse-oximeter sensor to the right hand or wrist, etc.). Immediately start CPAP application with mask and T-piece: the CPAP level will be set at 5 cmH2O. Perform gentle tactile stimulation if the child is not breathing in appropriately. Place the pulse-oximeter sensor on the right hand then connect it to the oxymeter previously turned on. Assess breathing and HR for 30 seconds. Perform the next step of the flow-chart of resuscitation in the delivery room according to the Neonatal Resuscitation Program guidelines. If positive pressure ventilation (PPV) is required (in case of persistent bradycardia or apnea), maintain PEEP at 5 cm H2O and an initial PIP of 25 cm H2O. The CPAP level will be raised to 6 cm H2O after 15 minutes of life, then the recording will be discontinued.
干预措施: static CPAP 5 cmH2O (Behavioral)
结局指标
主要结局
Oxygen saturation/Inspired Oxygen fraction (SpO2/FiO2)
时间窗: From randomization assessed every minute up to 15 minutes of life
Oxygen saturation / Inspired Oxygen fraction ratio
次要结局
- Exhaled tidal volumes (Vte)(From randomization assessed every minute up to 15 minutes of life)
- ET(From randomization up to 15 minutes of life)
- Surf(From randomization up to 72 hours of life)
- HR(From randomization assessed every minute up to 15 minutes of life)
- PPV(From randomization up to 15 minutes of life)
- PIE(From randomization up to 72 hours of life)
- MV(From randomization up to 72 hours of life)
- IVH(From randomization up to 72 hours of life)
- BPD(assessed at 36 weeks gestational age (GA))
- SpO2(From randomization assessed every minute up to 15 minutes of life)
- Death(From date of randomization until the date of death from any cause, assessed up to 40 weeks gestational age (GA))
- PNX(From randomization up to 72 hours of life)
研究者
Francesco Cavigioli
Principal Investigator
ASST Fatebenefratelli Sacco