Changing the Paradigm for Improving Neonatal Care: Clinical Study on Optimal Oxygen-saturation Time and the Adding Value of Parents to Nursing Care in the Control of Fi02
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Children maintained within the saturation ranges in each group
研究概览
简要总结
The purpose of this study is to determine whether saturation control by parents in children younger than 32 weeks or under 1500 g versus conventional care performed by nursing increases the time in which these patients remain at optimal saturation range. If the hypothesis of this study is confirmed premature infants could prevent episodes of hypoxia-hyperoxia and also give more relevance to the role of parents in caring for their children admitted in a neonatal intensive care unit.
详细描述
Both episodes of hyperoxia and hypoxemia in preterm infants increase morbidity and mortality. Nowadays the adjustment of FiO2 is manually controlled, which means it depends on the staff, needing multiple adjustments throughout the day.
The investigators's hypothesis is that the FiO2 control by parents, improve the percentage of time in range of optimum saturation at least 10% compared to control by nurses.
The aim of this study is to compare the proportion of time with oxygen saturation (SpO2) within the assigned target range, in the preterm infants whose parents modify the fraction of inspired oxygen (FiO2) versus the nursing staff modifying group.
This is a randomized controlled clinical study in the neonatal intensive care unit at Hospital 12 de Octubre. Patients will be randomized in two groups, Experimental Group: parents controlling the saturation ranges, they will manually adjust FiO2 versus the Control Group: controlled by nursing staff (standard procedure). Saturations will be registered and adjustments of FiO2 will be filmed for nonconsecutive 20-hours periods. Twenty-three patients will be enrolled in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 7 Days 至 9 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Related to child
- •Preterm neonates less than 32 weeks or less than 1500 g hospitalized in the Neonatal Intensive Care Unit at Hospital 12 de Octubre.
- •Receiving supplemental oxygen ≤0.4 administered by CPAP or conventional nasal cannula or high flow or children with BiPAP (flow generator with double level pressure)
- •Minimum age 7 days old.
- •Related to the mother:
- •Absence of health problems that allows her to perform the task.
- •Availability to frequently visit her baby with the father or with a companion, at least for 20 hours, not consecutive.
- •Understanding of the study and the Spanish language by the mother and father or companion.
- •Signed informed consent.
排除标准
- •Evidence of pneumothorax or pneumomediastinum.
- •Non-compliance with study protocol.
- •Requiring treatment with vasoactive drugs.
研究组 & 干预措施
Control by nursing.
FiO2 adjusted manually by nursing staff. Intervention: Other. Standard procedure
干预措施: Standard procedure (Other)
Control by parents.
FiO2 adjusted manually by parents. Intervention. Other. Experimental procedure
干预措施: Experimental procedure (Other)
结局指标
主要结局
Children maintained within the saturation ranges in each group
时间窗: 20-40 hours as maximum
Percentage of time the child is kept within the ranges of saturation in each group
次要结局
未报告次要终点
研究者
Carmen Rosa Pallas
Dra. Carmen Rosa Pallás Alonso
Hospital Universitario 12 de Octubre