Oxygenation Instability and Maturation of Control of Breathing in Premature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Central chemoreceptor control of breathing function
研究概览
简要总结
Premature infants present with significant oxygenation instability in the form of frequent spontaneous episodes of hypoxemia during the first weeks after birth. These infants are also exposed to hyperoxemia.
The objective of this study is to determine the extent to which exposure to frequent episodes of hypoxemia and hyperoxemia in extreme premature infants during the early stages of their evolving lung disease is associated with altered maturation and function of their respiratory control system.
This study is part of the Prematurity-Related Ventilatory Control (Pre-Vent): Role in Respiratory Outcomes Clinical Research Centers (CRC) (U01) cooperative program of the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH).
详细描述
Most extreme premature infants present with respiratory failure due to altered lung function compounded by breathing instability due to an immature respiratory control function.
Premature infants present with significant oxygenation instability in the form of frequent spontaneous episodes of hypoxemia during the first weeks after birth. As a result, these infants receive oxygen supplementation but this is often excessive and these infants are also exposed to hyperoxemia. The extent to which these episodes of hypoxemia or the exposure to hyperoxemia impact on the maturation and function of the control of breathing system in extreme premature infants during the evolving stages of their respiratory disease is unknown. This is a prospective study that will systematically evaluate such association in extreme premature infants.
The main objective of this study is to determine the extent to which exposure to frequent episodes of hypoxemia and hyperoxemia in extreme premature infants during the early stages of their evolving lung disease is associated with altered maturation and function of their respiratory control system.
This study is part of the Prematurity-Related Ventilatory Control (Pre-Vent): Role in Respiratory Outcomes Clinical Research Centers (CRC) (U01) cooperative program of the National Heart Lung and Blood Institute (NHLBI) of the National Institutes of Health (NIH).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Premature infants born at 23 0/7- 28 6/7 weeks gestational age
- •Postnatal age up to equivalent to 36 weeks postmenstrual age
- •Requiring supplemental oxygen and/or receiving mechanical ventilation, CPAP, nasal ventilation or nasal cannula
排除标准
- •Severe congenital anomalies that may affect life expectancy or pulmonary or neurosensory development
- •Severe CNS pathology that may alter respiratory control function
结局指标
主要结局
Central chemoreceptor control of breathing function
时间窗: at 36 weeks corrected postmenstrual age
Ventilatory response to carbon dioxide
Peripheral chemoreceptor control of breathing function
时间窗: at 36 weeks corrected postmenstrual age
Ventilatory response to oxygen (Dejours test)
Change in peripheral chemoreceptor control of breathing function
时间窗: Change from 32 to 36 weeks postmenstrual age
Ventilatory response to oxygen (Dejours test)
Change in central chemoreceptor control of breathing function
时间窗: Change from 32 to 36 weeks postmenstrual age
Ventilatory response to carbon dioxide
次要结局
- Ventilatory stability - Periodic breathing density(at 32 and 36 weeks corrected postmenstrual age)
- Ventilatory stability - Apnea frequency(at 32 and 36 weeks corrected postmenstrual age)
- Ventilatory stability - Time series analysis of inter-breath interval(at 32 and 36 weeks corrected postmenstrual age)
- Apneic CO2 threshold during mechanical ventilation(at 32 and 36 weeks corrected postmenstrual age)
- Mechanisms of episodic hypoxemia(at 32 and 36 weeks corrected postmenstrual age)
- Apneic CO2 threshold in central apnea(at 32 and 36 weeks corrected postmenstrual age)
研究者
Nelson Claure
Associate Professor
University of Miami