Supraglottic Airway Interface for Positive Pressure Ventilation During Delivery Room Resuscitation of Premature Infants: A Pilot Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Feasibility of Supraglottic Airway as Primary Ventilation Interface
研究概览
简要总结
The goal of this single-arm intervention trial is to learn whether using a supraglottic airway (SA) as the primary interface for positive pressure ventilation (PPV) is feasible during delivery room resuscitation of premature infants. This study will be conducted in premature infants born between 29 0/7 and 33 6/7 weeks' gestation who require PPV at birth.
The main question it aims to answer is: Is it feasible to use a supraglottic airway as the primary interface to provide effective PPV during delivery room resuscitation in 29 0/7 to 33 6/7 weeks' gestation premature infants?
Participants will (1)Be screened prenatally and have informed consent obtained from the birth parent prior to delivery; (2)Be rescreened for eligibility on the day of delivery before receiving the study intervention; (3)Receive PPV using a supraglottic airway as the primary ventilation interface if resuscitation is required at birth; and (4)Have clinical and procedural data collected during delivery room resuscitation and for up to 24 hours after birth.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age 29 0/7 to 33 6/7 weeks at birth
- •Estimated fetal weight >/= 1000 grams at birth
- •Clinical decision to initiate PPV
- •Parental informed consent
排除标准
- •Major anomalies or aneuploidy
- •Palliative care planned or considered
- •Not resuscitated in the infant resuscitation room
研究组 & 干预措施
Supraglottic Airway
Premature infants who require positive pressure ventilation immediately after birth will receive ventilation through a supraglottic airway used as the primary airway interface during delivery room resuscitation.
干预措施: Supraglottic Airway (Other)
结局指标
主要结局
Feasibility of Supraglottic Airway as Primary Ventilation Interface
时间窗: Immediately after birth (up to 10 minutes of life)
Feasibility defined as successful use of a supraglottic airway as the primary interface to deliver positive pressure ventilation for up to 10 minutes of life or until discontinuation of positive pressure ventilation, without need for immediate escalation to an alternative airway interface.
次要结局
- Time to Supraglottic Airway Placement During Resuscitation(Immediately after birth)
- Duration of Supraglottic Airway Use During Resuscitation(Immediately after birth)