A Randomised Trial of Routine or Selective Application of a Face Mask for Preterm Infants at Birth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 201
- 试验地点
- 1
- 主要终点
- The proportion of participants who receive face mask PPV in the delivery room DR
研究概览
简要总结
International guidelines recommend giving positive pressure ventilation (PPV) by face mask to newborns who do not breathe or have a slow heart rate at birth. Preterm infants are at high risk of developing respiratory distress syndrome (RDS) and many are treated with continuous positive airway pressure (CPAP) in the neonatal intensive care unit (NICU). Though the majority of preterm infants breathe spontaneously at birth, many clinicians routinely apply a face mask to preterm infants shortly after birth in the delivery room (DR) to give them CPAP. However, applying a face mask may inhibit spontaneous breathing in newborns. In this study, premature babies will be randomly assigned to have a face mask routinely applied for CPAP shortly after birth; or to have a face mask selectively applied only for PPV if they are not breathing or have a slow heart beat in the first 5 minutes of life, or for CPAP if they have signs of respiratory distress after 5 minutes. The investigators will determine whether fewer participants who have the mask selectively applied receive PPV in the DR.
详细描述
Newly born babies have fluid-filled lungs that they must quickly aerate after birth. Compared to infants born at term, preterm babies have greater difficulty in establishing and maintaining aeration of their lungs; this leaves them at increased risk of developing respiratory distress syndrome (RDS). Infants who develop RDS are treated with nasal continuous positive airway pressure (CPAP), and may progress to treatment with surfactant and mechanical ventilation, in the Neonatal Intensive Care Unit (NICU).
The Neonatal Task Force of the International Liaison Committee on Resuscitation (ILCOR) makes recommendations on the treatment of infants at birth. ILCOR recommends assessing the breathing and heart rate (HR) of all newborns, and:
- Giving positive pressure ventilation (PPV) to babies who have a HR < 100bpm, gasping or apnoea
- Considering giving CPAP to babies who have laboured breathing or persistent cyanosis
Most preterm infants breathe spontaneously at birth. Despite this, the majority of preterm infants have a facemask applied for respiratory support immediately after birth, usually before the HR has been determined. Clinicians presumably do this to give early support to infants they believe are at high risk of developing RDS in an attempt to prevent or lessen the severity of the disease.
There is little evidence that giving preterm infants prophylactic nasal CPAP may be superior to supportive care with oxygen. A study that compared nasopharyngeal CPAP to supportive care with oxygen performed before antenatal steroids were routinely given found no difference in the rate of development of RDS with the application of CPAP. Two more recent studies did not show that early application of nasal CPAP reduced the rate of intubation or treatment with surfactant. In these studies CPAP was given by nasal prongs and was started at 15 - 30 minutes of life, not immediately with a facemask. There is no evidence that facemask CPAP immediately after birth prevents or reduces the severity of RDS.
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
盲法说明
Masking of caregivers not feasible due to the nature of the intervention
入排标准
- 年龄范围
- 0 Minutes 至 5 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born before 32 weeks gestational age by best obstetric estimate
排除标准
- •Infants with major congenital anomalies
研究组 & 干预措施
Routine face mask application
Routine application of a face mask shortly after birth to deliver continuous positive airway pressure (CPAP)
干预措施: Face mask application for CPAP and/or PPV delivery (Other)
Selective face mask application
Selective application of a face mask to give positive pressure ventilation (PPV) for apnoea or bradycardia [heart rate (HR) < 100 beats per minute (bpm)] at any time in the delivery room (DR); or to give CPAP for signs of respiratory distress after 5 minutes of life
干预措施: Face mask application for CPAP and/or PPV delivery (Other)
结局指标
主要结局
The proportion of participants who receive face mask PPV in the delivery room DR
时间窗: Within 30 minutes of birth
The proportion of participants who receive face mask positive pressure ventilation (PPV) in the delivery room (DR)
次要结局
- The proportion of participants who receive face mask PPV in the first 5 minutes of life(5 minutes)
- The proportion of participants who receive face mask CPAP in the first 5 minutes of life(5 minutes)
- HR at 5 minutes of life(5 minutes)
- SpO2 at 5 minutes of life(5 minutes)
- The proportion of participants who receive face mask CPAP in the DR(Within 30 minutes of birth)
- The proportion of participants who are intubated in the DR(Within 30 minutes of birth)
- Duration of PPV in the DR(Within 30 minutes of birth)
- The proportion of participants who receive volume in the DR(Within 30 minutes of birth)
- Apgar score at 10 minutes(10 minutes)
- The proportion of participants who receive chest compressions in the DR(Within 30 minutes of birth)
- Apgar score at 5 minutes(5 minutes)
- The proportion of participants who receive NCPAP in NICU(Within one month)
- The proportion of participants who die before hospital discharge(Through study completion, an average of 2-3 months in survivors)
- Maximum FiO2 in the DR(Within 20 minutes of birth)
- The proportion of participants who receive surfactant treatment(Within one month)
- The proportion of participants who receive home oxygen therapy(Through study completion, an average of 2-3 months in survivors)
- The proportion of participants who receive adrenaline in the DR(Within 30 minutes of birth)
- Respiratory support in transport to NICU(Within 45 minutes of birth)
- The proportion of participants who receive endotracheal ventilation in NICU(Within one month)
- The proportion of participants who receive postnatal steroids(Through study completion, an average of 2-3 months in survivors)
- The proportion of participants who have a pneumothorax drained(Within one month)
- The proportion of participants who survive free of BPD(Day 28 of life)
- The proportion of participants who receive survive free of CLD(36 weeks corrected)