A Single-arm, Prospective Feasibility Study of Placement and Surfactant Administration Through a Preterm Size Laryngeal Mask Airway in Very Low Birth Weight Neonates, With Respiratory Distress Syndrome, at a Level III Neonatal Intensive Care Unit in Hanoi, Vietnam
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Successful LMA placement, with signs of adequate airway, allowing two attempts.
研究概览
简要总结
Surfactant administration via a supraglottic airway device or laryngeal mask airway (SALSA) is a minimally invasive method of instilling surfactant in the trachea during spontaneous breathing and after applying nasal continuous positive airway pressure (nCPAP). However, the procedure has been limited from use in very low birth weight neonates, due to lack of preterm size LMAs, which are now emerging on the market.
The goal of this study is to see if investigators can successfully use a new, smaller laryngeal mask airway (LMA) to place and give surfactant to premature babies with respiratory distress syndrome (RDS) who weigh between 750g and 1500g at birth.
The main objectives of the study are to:
- Check the placement of the new, smaller LMA: This includes evaluating the airway, how long it takes to place the LMA, how many attempts are needed, and the baby's stability during the process.
- Evaluate the administration of surfactant using the new LMA: Investigators will look at how the baby responds clinically, any changes in oxygen needs, how many doses of surfactant are required, the level of respiratory support needed, and whether intubation or mechanical ventilation is necessary.
- Ensure the safety of using the new LMA and administering surfactant: Investigators will monitor the baby's stability during the procedure and watch for any adverse events.
- Assess pain during the procedure: Investigators will evaluate pain levels using a pain scale based on video reviews.
Above objectives of feasibility are to be assessed before proceeding to a large randomize clinical trial assessing effectiveness and safety.
详细描述
Methodology Feasibility will be measure by a combination of real-life observations of the procedure and video-review with synced physiological data (oxygen saturation and heart rate).
Study Site The Phu San Hanoi Hospital, the largest obstetric hospital in northern Vietnam, receives about 40.000 births annually and has a level-III neonatal intensive care unit with capacity of approximately 40 neonates. Approximately 10-15 neonates weighing less than 1500g per month are admitted who receives standard surfactant treatment with IN-tubation-SURfactant-Extubation (INSURE).
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
- — 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parental informed consent, AND
- •Inborn neonate (=born in the hospital), AND
- •Gestational age less than 34 + 0 weeks, AND
- •Age less than 48 hours, AND
- •Birth weight from 750g to 1500g, AND
- •Clinical diagnosis of RDS requiring non-invasive respiratory support (CPAP/NIPPV) and fraction of inspired oxygen (FiO2) 0.30-0.60 to maintain oxygen saturation (SpO2) between 90% and 95%.
排除标准
- •Severe respiratory insufficiency in need of emergency intubation
- •Previous surfactant administration
- •Previous mechanical ventilation
- •Known pneumothorax
- •Major malformations
- •Investigators not available
结局指标
主要结局
Successful LMA placement, with signs of adequate airway, allowing two attempts.
时间窗: During procedure. 0-30 minutes.
Categorical variable (Yes/No) A successful placement attempt is defined as insertion of the LMA into the infant's mouth with signs of adequate airway, as per judgement of the physician performing the procedure. Factors that will be considered are carbon dioxide (CO2)-detection, chest movement, pulmonary auscultation of bilateral breath sounds, oxygen saturation and heart rate.
次要结局
- Confirmation of carbon dioxide on carbon dioxide detector(During procedure. 0-30 minutes.)
- Bilateral breath sounds by auscultation during LMA placement(During procedure. 0-30 minutes.)
- Fluctuations in heart rate during placement(During procedure. 0-30 minutes.)
- Duration of SpO2 less than 40%(During procedure. 0-30 minutes.)
- Chest rise during LMA placement(During procedure 0-30 minutes.)
- Number of attempts required for successful placement(During procedure. 0-30 minutes.)
- Attempt duration more than 30 seconds(During procedure. 0-30 minutes.)
- Duration of each LMA placement attempt(During procedure. 0-30 minutes.)
- Time between attempts(During procedure. 0-30 minutes.)
- Duration of SpO2 less than 80%(During procedure. 0-30 minutes.)
- Duration of SpO2 less than 60%(During procedure. 0-30 minutes.)
- Fluctuations in oxygen saturation (SpO2) during placement(During procedure. 0-30 minutes.)
- Fluctuations in heart rate during surfactant administration(During procedure. 0-30 minutes.)
- Fluctuations in oxygen saturation (SpO2) during surfactant administration(During procedure. 0-30 minutes.)
- Duration of heart rate less than 100 beats per minute (bpm)(During procedure. 0-30 minutes.)
- Duration of heart rate less than 60 beats per minute (bpm)(During procedure. 0-30 minutes.)
- Volume of surfactant in gastric residuals after the procedure(During procedure. 0-30 minutes.)
- Total procedure duration(During procedure. 0-30 minutes.)
- Duration of positive pressure ventilation during LMA placement(During procedure. 0-30 minutes.)
- Duration of positive pressure ventilation during surfactant administration(During procedure. 0-30 minutes.)
- Duration of positive pressure ventilation during procedure(During procedure. 0-30 minutes.)
- Fraction of inspired oxygen(10 minutes before procedure until 1 hour after procedure.)
- Number of bradycardia less than 60 bpm for more than 10 seconds(During procedure. 0-30 minutes.)
- Number of desaturations to less 80% for more than 30 seconds(During procedure. 0-30 minutes.)
- Number of apneas lasting more than 20 seconds(During procedure. 0-30 minutes.)
- Need for early redosing of surfactant(Within 6 hours from first surfactant administration)
- Need for invasive mechanical ventilation within 72 hours(Within 72 hours after surfactant administration)
- Death(Within 7 days after birth)
- Duration of oxygen requirement after surfactant administration(Within 7 days after birth)
- Duration of continuous positive airway pressure (CPAP) after surfactant administration(Within 7 days after birth)
- Duration of non-invasive positive pressure ventilation (NIPPV) after surfactant administration(Within 7 days after birth)
- Duration of invasive mechanical ventilation after surfactant administration(Within 7 days after birth)
- Number of surfactant doses given(Within 7 days after birth)
- Need for subsequent intubation and mechanical ventilation(Within 7 days after birth)
- Administration method for subsequent surfactant doses(Within 7 days after birth)
研究者
Tobias Alfvén
Professor of Global Child Health
Karolinska Institutet