Neonatal Supraglottic Airway Trial: A Single-centre, Open-label, Randomized Clinical Trial to Evaluate the Efficacy of I-gel® Supraglottic Airway Used in Neonatal Resuscitation in Reducing Early Neonatal Mortality and Morbidity
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,163
- 试验地点
- 1
- 主要终点
- Composite outcome of either a) early neonatal death or b) neonatal encephalopathy
研究概览
简要总结
Mortality rates from birth asphyxia in low-income countries remain very high. Face mask ventilation (FMV) is the most common method of resuscitating neonates in such settings. It is mostly performed by midwives but may not always be satisfactory. The i-gel® is a cuffless supraglottic airway which is easy to insert and provides an efficient seal that prevents air leakage with the potential to enhance the performance of neonatal resuscitation. Midwives can be trained in a short time to use this method. A pilot study in Uganda has demonstrated that midwives can safely perform resuscitation of newborn with the i-gel.
OBJECTIVE To investigate whether the use of a cuffless supraglottic airway compared to face-mask ventilation during neonatal resuscitation can reduce early neonatal death (before 7 days of life) or morbidity in neonatal encephalopathy (NE) in asphyxiated neonates.
STUDY DESIGN, SETTING AND POPULATION A single-centre randomized clinical trial will be conducted at Mulago National Referral Hospital, Kampala, Uganda, among asphyxiated neonates in the delivery units. Prior to the intervention, all staff in the labour ward performing resuscitation will receive training according to the HBB curriculum with a special module for training on supraglottic airway insertion. Resuscitation will be performed according to international guidelines.
UTILITY OF THE STUDY It is crucial to explore alternative, cost-effective modalities that not only would reduce mortality, but also the burden of neurological damage in survivors.
详细描述
One of the targets in the SDG-3 is to reduce neonatal mortality to less than 12 per 1000 live births by 2030. This will require considerable effort in many low-income countries. Perinatal mortality contributes to 40% of infant mortality in Uganda. Early neonatal death from birth asphyxia (BA) could be as high 60%. New evidence-based strategies are needed to reduce mortality from BA in order to achieve SDG-3 by 2030.
Optimal care of the depressed newborn is crucial to prevent and manage BA. The challenge in low-income settings is that highly qualified staff is not readily available to attend to the newborn who require their expertise. In most cases, the midwives are the most skilled personal attending to deliveries and also responsible for resuscitating newborns. At present in low-income settings, FMV is the commonly used method for resuscitating depressed newborn. Easy-to-use equipment such as a supraglottic airway could contribute to obtain more effective ventilation, and improve the outcome of the infant.
This trial is based on a previous pilot trial ClinicalTrials.gov Identifier: NCT02042118.
Primary objective
• To assess if the proportion of either early neonatal death or neonatal encephalopathy (admission to NICU with a Thompson score of 11 or above in day 1-5 during hospitalisation), can be decreased from 40 % in the control arm (using FM) to 30 % or less in the intervention arm (using i-gel supraglottic airway), a 25% decrease.
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 (Outcomes Assessor)
盲法说明
The neonatologists assessing the Thompson score will be blinded to the intervention arm. Other staff members will know about the arm allocation.
入排标准
- 年龄范围
- — 至 10 Minutes（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inborn baby (=born in the hospital)
- •Expected ≥ 34-week gestation
- •Expected birth weight ≥ 2000 g
- •Need for PPV at birth
- •Parental consent
排除标准
- •Major malformations (incompatible with sustained life or affecting the airways)
研究组 & 干预措施
Supraglottic airway
All newborns in need of resuscitation in this arm will receive initial treatment with positive pressure ventilation using a supraglottic airway and a bag.
干预措施: Supraglottic airway (Device)
Face-mask
All newborns in need of resuscitation in this arm will receive initial treatment with positive pressure ventilation using a face-mask and a bag.
干预措施: Face-mask (Device)
结局指标
主要结局
Composite outcome of either a) early neonatal death or b) neonatal encephalopathy
时间窗: Day 7 of life
A composite outcome of a) early neonatal death (within 7 days) b) neonatal encephalopathy (admission to NICU with a Thompson score of 11 or above in day 1-5 during hospitalisation).
次要结局
- Early neonatal death(Day 7 of life)
- Neonatal encephalopathy(Day 7 of life)
- Advanced resuscitation(Day 7 of life)
- Mild neonatal encephalopathy(Day 7 of life)
- Any hospital admission(Day 7 of life)
- Number of adverse events (AEs) and serious adverse events (SAEs)(Day 7 of life)
- Very early neonatal death(Day 1 of life)