Exposure to Biological Maternal Sounds in Extremely Preterm Infants: Effects on Short- and Long-term Outcomes
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Brain volume (DM^3)
研究概览
简要总结
The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal sensory stimulation can influence physical growth, brain maturation, respiratory stability and early vocalization during postnatal development. The investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental in premature infants and will increase their potential to grow into healthy children.
详细描述
The purpose of this RCT is to learn more about how sounds that we experience in the womb can affect early development in premature infants. The investigators are specifically interested determining whether and what types of maternal auditory stimulation can influence physical growth, brain maturation, respiratory stability (including heart rate, respiratory rate and oxygen saturation levels) as well as early vocalization prior to 40 weeks gestation. The investigators hypothesize that daily exposure to biological maternal sounds, such as mother's voice and heartbeat, will improve both short-term and long-term developmental outcomes in premature infants and will increase their potential to grow into healthy children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 24 Weeks 至 34 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Born between 24-36 weeks GA.
排除标准
- •Chromosomal or congenital anomalies; congenital infections; > grade II IVH;
- •maternal use of tobacco, alcohol, or illicit drugs;
- •significant abuse or malnutrition during pregnancy,
- •failed ABR.
- •No exclusions based on gender or ethnicity.
结局指标
主要结局
Brain volume (DM^3)
时间窗: Between 36-40 weeks gestation
Data will be obtained by an MRI brain scan and will be calculated separately for white matter, grey matter, CSF.
Language and cognitive skills
时间窗: At 12 and 24 months corrected-age
Data will be obtained using the MacArthur-Bates Communicative Development Inventories (CDI), the Receptive-Expressive Emergent Language Test Third Edition (REEL-3), and the Bayley Scales of Infant Development Third Edition (Bayley-III).
次要结局
- Oxygen saturation levels (mg/l)(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Heart rate (BPM)(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
- Infant vocalization (word count)(Between 32-36 weeks gesation)
- Weight gain (gr/kg/day)(participants will be followed for the duration of hospital stay, an expected average of 6 weeks)
研究者
Amir Lahav
Instructor in Pediatrics
Brigham and Women's Hospital