Effects of Clustering Care on the Physiological Stability of Preterm Infants in a Neonatal Intensive Care Unit.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Physiological stability (heart rate, respiratory rate and oxygen saturation)
研究概览
简要总结
This crossover design experimental study aims to compare the physiological stability of premature newborns during and after a cluster of care compared to a period when they receive standard non clustered care at the neonatal unit.
详细描述
The cluster care will take place at the time of feeding of the premature infants. The intervention will start with a calm period of 20 minutes before the start of care (no manipulations will be allowed), the baby will then received the cluster care for 20 minutes and a quiet period of 30 minutes will follow after the cluster care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 26 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 26 to 31 6/7 weeks of gestation at birth
- •more than 72 hours of life,
- •receive a respiratory aid such as endotracheal tube, NIPPV (non invasive positive pressures ventilation), CPAP (continuous positive airway pressure) or nasal prongs with oxygen,
- •are fed intravenously (IV) or by central venous catheter (CVC),
- •one of the parents speaks and reads English or French,
- •one of the parents is at least 18 years old to sign the consent.
排除标准
- •severely ill (necrotizing enterocolitis, septicemia),
- •under respiratory assistance or on a high frequency mode,
- •having a congenital or cardiac abnormality,
- •requiring surgery,
- •sedatives or opioids,
- •diagnosed with grade II, III or IV intraventricular hemorrhage and / or hydrocephalus,
- •have a device for invasive blood pressure,
- •having an oxygen requirement of more than 30% to maintain oxygen saturation within the limits indicated by the NICU (neonatal intensive care unit).
- •one of the parents is at least 18 years old to sign the consent.
结局指标
主要结局
Physiological stability (heart rate, respiratory rate and oxygen saturation)
时间窗: The physiological stability will be measured for 70 minutes.
The physiological stability will be measured with the SCRIP score. The Stability of the cardiorespiratory system in premature infants is a scale, in which a score of 0 means major physiological instability and a score of 6 means a physiological stability. For every single parameter there's three grades from severe instability (0 points) to minor instability (1 point) to perfect stability (2 points).
次要结局
未报告次要终点
研究者
Abril Nicole Fernandez Oviedo
Principal investigator
Université de Montréal