跳至主要内容
临床试验/CTRI/2010/091/006121
CTRI/2010/091/006121未知Phase 3 4

Maternal music exposure during pregnancy influences Neonatal Behaviour

Department of Pediatrics, NSCB Medical College, Jabalpur, MP1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 待定

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

研究者

发起方
Department of Pediatrics, NSCB Medical College, Jabalpur, MP

研究点 (1)

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