Clinical Trial to Assess the Clinical Impact, Efficacy and Safety of Customized Nasal Masks Designed by 3D Printing During Non-invasive Ventilation in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Time in which preterm maintain SatO2 below 85%.
研究概览
简要总结
Clinical trial with crossed groups, open, masked for the evaluation of the main outcome. Inclusion of all premature infants with a birth weight less than 1500 g requiring Non-invasive Ventilation (NIV).
Premature will be randomised to start alternatively with MT or 3DM. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days.
To compare the time in which preterm maintain SatO2 below 85% with the 3DM versus the traditional mask (TM) in preterm < 1500 g. Other secondary objectives regarding ventilation enhancement will be assessed, such as the number of bradycardias, cardiorespiratory arrest and need for resuscitation in the context of apnea. Also, skin lesions of the nose resulting from the pressure applied by any of the masks (TM or 3DM) and the need for analgesia and/or sedation for pain control or discomfort will be assessed. Parental perception and satisfaction will be assessed.
详细描述
Improvement and optimization of non-invasive ventilation (NIV) in preterm and low birth weight infants is essential in order to reduce morbidity. By the use of 3D printing design (3DM), these infants would be provided with customized nasal masks, according to their particular anatomical features while on NIV. This would lead to a greater stabilization of the respiratory system, decreased apnea spells, oxygen desaturation and bradycardia, less need for intubation and less skin nose injury, all of which might improve neurodevelopmental outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborn prematurity
- •Age: less than 30 days of life
- •Required respiratory support with non-invasive ventilation (NIV)
- •Premature infant has not been on NIV for more than 3 days before being included in the trial.
- •Signature of the Informed Consent (IC)
排除标准
- •Failure to meet entry criteria
- •Cyanotic congenital heart disease diagnosis
- •Presence of serious malformations
- •Presence of airway malformations
结局指标
主要结局
Time in which preterm maintain SatO2 below 85%.
时间窗: 7 days
To compare the time in which preterm maintain SatO2 below 85%.in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).
次要结局
- Time in which preterm maintain SatO2 below 75%.(7 days)
- Appearance of cutaneous lesions in nasal region or mucosa(7 days)
- Time in which preterm maintain bradycardias.(7 days)
- Pain assessment with scoring scale.(7 days)
- Number of times requiring cardiopulmonary resuscitation(7 days)
研究者
María Teresa Moral Pumarega
Associate Professor of Pediatrics at the Complutense University of Madrid (UCM)
Hospital Universitario 12 de Octubre