Womb Recordings and Respiratory Control Maturation in Neonates
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- mean heart rate
研究概览
简要总结
The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants.
详细描述
The aim of this proposal is to characterize the acute effect of early postnatal sound exposure on neuronal maturation of the respiratory control regions of the brain in preterm infants. We hypothesize that exposure to appropriately designed womb-like sounds in the Neonatal Intensive Care Unit (NICU) will induce a more mature and stabilized cardiorespiratory pattern manifesting as a decrease in apnea, bradycardia, intermittent hypoxemia and mean heart rate.
This proposal lays the foundation for further development of actual womb and maternal voice recordings containing components that closely mimic the womb environment during 33-34 weeks of gestation, a proposed therapeutic window of brain development. These sound recordings will provide low risk interventions sorely needed to stabilize respiration, reduce intermittent hypoxemia and induce maturation of neuronal respiratory networks during this critical stage of development.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The order of the sound exposure will be randomized within each subject. The outcomes assessor (quantifying cardiorespiratory events) will be blinded as to the order of the 6 hour randomization blocks within the 24 hour study.
入排标准
- 年龄范围
- 1 Week 至 5 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm infants 29-33 weeks gestational age at birth
- •34 weeks corrected age
- •off respiratory support >1.5 lpm
排除标准
- •on respiratory support >1.5 lpm
- •congenital anomalies
研究组 & 干预措施
Ambient noise followed by Womb sound
At 34 weeks corrected age, preterm infants (29-33 weeks gestational age at birth), who are off respiratory support >1.5 lpm, will be exposed to alternating 6-hour periods of a recording of ambient noise followed by commercially available womb sounds over a 24-hour period for a combined total of 12 hours of womb sounds and 12 hours of ambient noise.
干预措施: Womb sound recordings (Other)
Womb sound recordings followed by ambient noise
At 34 weeks corrected age, preterm infants (29-33 weeks gestational age at birth), who are off respiratory support >1.5 lpm, will be exposed to alternating 6-hour periods of a recording of commercially available womb sounds followed by ambient noise over a 24-hour period for a combined total of 12 hours of womb sounds and 12 hours of ambient noise.
干预措施: Womb sound recordings (Other)
结局指标
主要结局
mean heart rate
时间窗: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
mean heart rate
respiratory pauses
时间窗: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Respiratory pauses of \>5sec will be documented to increase the chance of capturing small alterations in respiratory stability.
cardiorespiratory events
时间窗: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
Apnea (\>20 seconds or shorter with intermittent hypoxemia \<85% or bradycardia \<80bpm)
intermittent hypoxemia
时间窗: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
falls in oxygen saturation \<85%
bradycardia
时间窗: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
heart rate \<80bpm
body motion
时间窗: During the 24 hour period of randomized blocks of womb sound recordings and ambient noise
non-cardiac alterations in the oximeter plethysmograph waveform
次要结局
未报告次要终点