NEWBORN VENTILATION IN THE DELIVERY ROOM: CAN IT BE IMPROVED WITH A T-PIECE RESUSCITATOR? Multicenter Cross-over Cluster Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,032
- 试验地点
- 17
- 主要终点
- Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.
研究概览
简要总结
A multicenter cross-over cluster randomized controlled trial protocol study in newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (positive pressure ventilation [PPV]) for resuscitation in the delivery room comparing a T-piece resuscitator device versus resuscitation bag.
详细描述
Design: A multicenter cross-over cluster randomized controlled trial. Our hypothesis is based on the assumption that ventilating depressed newborns with a T-piece resuscitator will be more effective than SIB by increasing the proportion of resuscitated newborns with heart rate (HR) ≥ 100 beats per minute (bpm) at two minutes of life as a proxy for successful resuscitation.
Population: Newborn infants ≥ 26 weeks gestational age requiring assisted ventilation (PPV) for resuscitation in the delivery room.
(need for assisted ventilation at positive pressure: Heart Rate [HR] < 100 beats per minute [bpm], apnea, gasping, cyanosis and/or hypotonia)
Intervention: PPV will be performed with a T-piece resuscitator (Neopuff® group) with positive end expiratory pressure.
Control: PPV will be performed with a self inflating bag (SIB group) with and without PEEP.
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 2 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Live-born infants of ≥ 26 weeks' GA with HR < 100 bpm requiring resuscitation with positive pressure ventilation with mask in the delivery room according to the current AAP/AHA recommendations
排除标准
- •Infants requiring intubation from birth. Newborns of < 26 weeks´ GA. Newborns presenting major congenital malformations. Multiple births. Problems (difficulty or malfunctioning) with the device assigned.
研究组 & 干预措施
Neopuff TM with PEEP
Newborns ventilated for neonatal resuscitation using Neopuff TM with PEEP
干预措施: T-piece resuscitator Neopuff TM (Device)
Self Inflating Bag with PEEP
Newborns ventilated for neonatal resuscitation using Self Inflating Bag with PEEP valve attached
干预措施: Self Inflating Bag with PEEP (Device)
Self Inflating Bag without PEEP
Newborns ventilated for neonatal resuscitationusing Self Inflating Bag without PEEP valve attached
干预措施: Self Inflating Bag without PEEP (Device)
结局指标
主要结局
Proportion of Infants With a HR ≥ 100 Bpm at 2 Minutes of Life.
时间窗: 2 minutes of life
次要结局
- • SpO2 Value at 2 Minutes of Life.(2 minutes of life)
- • Incidence of Neonatal Encephalopathy During First Week of Life (Classified by Sarnat)(first week of life)
- Time the Newborn Takes to Reach a HR > 100 Bpm(2 minutes of life)
- • Proportion of Eligible Newborns Who Entered the Study and Who Were Intubated After Failure of PPV With Mask.(after 2 minutes of life)
- • Need for Chest Compression and/or Medications(after 2 minutes of life)
- • Incidence of Air Leaks(after birth and during hospitalization up to four weeks)
- • Need for Mechanical Ventilation or CPAP(during hospitalization)
- • Use of Oxygen Treatment Beyond the Delivery Room(during hospitalization)
- Days on Oxygen(after birth and during hospitalization up to four weeks)
- Apgar Scores at 1 and 5 Minutes(1-5 minutes of life)
- Days on Mechanical Ventilation(after delivery and before four weeks)
- Days on CPAP(after birth and during hospitalization up to four weeks)
- • Incidence of Intracranial Hemorrhage Grades 3-4 for Preterm Newborns <32 Weeks(1 day of life and 30 days after birth)
研究者
Edgardo Szyld
Principal Investigator
Fundacion para la Salud Materno Infantil