Maternal music exposure during pregnancy influences Neonatal Behaviour
试验速览
- 阶段
- Phase 3 4
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- performance on Brazelton Neonatal Behavioral Assessment Scale (BNBAS)
研究概览
简要总结
Objective: Auditory stimulation during pregnancy has been found to influence foetal behaviour with a potential of being carried forward to neonatal period. This study evaluated the effect of ante-natal music exposure to primigravida healthy mothers on the behaviour of their term appropriate-for-date newborns assessed using Brazelton Neonatal Behavioral Assessment Scale (BNBAS). Methods: This was a single centre, randomized, open-label controlled trial. Primigravida mothers aged 19-29 years, free of chronic medical diseases or significant deafness, with singleton pregnancy, with a gestation of 20 weeks or less were randomized to listen to a pre-recorded music cassette for approximately 1 hour/day in addition to standard ante-natal care (intervention arm) or standard care only (control arm). Peri-natal factors with adverse effect on neonatal behaviour were deemed as protocol violations. Outcome measure included scores on 7 clusters of BNBAS. Primary analysis was per protocol.
研究设计
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
入选标准
- •Primigravida mothers * 19 to 29 years of age * Singleton pregnancy* Less than 20 weeks of gestation.
排除标准
- •Mothers with significant co-existing medical diseases* Severe to profound hearing loss.
结局指标
主要结局
performance on Brazelton Neonatal Behavioral Assessment Scale (BNBAS)
时间窗: Day 3 of life
次要结局
未报告次要终点
