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临床试验/NCT05223192
NCT05223192招募中不适用

The Effects of Entrainment on Respiratory Stability and Cerebral Oxygenation in Preterm Infants

Icahn School of Medicine at Mount Sinai1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
120
试验地点
1
主要终点
Heart Rate

研究概览

简要总结

Infants born prematurely at will be asked to participate in this randomized controlled trial at a corrected gestational age of 24-37 weeks. Infants will be randomly selected to each of the two groups: intervention and control. Infants in the treatment group will receive six intervention days over a two-week period, 3 sessions per week. Each intervention day consists of each of the two interventions in a random sequence: no intervention/silence and live ocean disc instrument intervention. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation. Each infant will thus receive control and ocean disc intervention on the same day in the NICU. Interventions will be given in a randomized order (i.e., first ocean disc or first silence, randomized to AM or PM), with observation occurring for 10 minutes before each intervention, 15 minutes during each intervention, and 10 minutes after each per session. There will be 3 sessions per week for a two-week randomized treatment schedule. For each infant, data on total apnea time, mean respiratory rate, heart rate, O2 levels and behavior rating during will be collected. The sound decibel level will also be recorded and maintained at 40-65dB to prevent overstimulation and hearing damage. Near-infrared light spectroscopy (NIRS) data on cerebral oxygenation will also be collected. Observations will be recorded on the infant's activity or when change occurs, such as a pacifier falling out. Parents and nurses will be asked to behave as they normally would during routine care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
24 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Newborns born at 24-37 weeks' gestation at Mount Sinai hospital
  • •Newborn is considered appropriate for clinically indicated music therapy

排除标准

  • •Infant not expected to survive 24 hours from the time of study entry (To be assessed by a member of the NICU Faculty other than the PI)
  • •Infant of uncertain viability (gestation <23 weeks, birth weight <500 grams)
  • •Known or suspected genetic disorder (e.g., Trisomy 21)
  • •Identified hearing disorder

研究组 & 干预措施

Intervention group

Experimental

Participants in this group will receive the ocean disc music therapy entrainment intervention

干预措施: Music Therapy Entrainment with Ocean Disc Intervention (Behavioral)

Control group

No Intervention

Participants in this group will not receive any intervention

结局指标

主要结局

Heart Rate

时间窗: 14 days

Oxygen-Saturation Level

时间窗: 14 days

Weight

时间窗: 14 days

Respiratory Rate

时间窗: 14 days

Cerebral oxygen saturation

时间窗: 14 days

Cerebral oxygen saturation measured using NIRS

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joanne Loewy

Associate Clinical Professor

Icahn School of Medicine at Mount Sinai

研究点 (1)

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