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临床试验/CTRI/2025/07/089918
CTRI/2025/07/089918尚未招募不适用

Effectiveness of parent-administered multisensory stimulation using the “Auditory Tactile Visual Vestibular intervention (ATVV)” on infant sensory processing, breastfeeding performance and postpartum bonding in mothers of hospitalized premature infants, when compared to usual care- A randomized controlled trial

Christian Medical College1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2025年7月2日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
82
试验地点
1
主要终点
Sensory processing ability of infants using the Infant Sensory

研究概览

简要总结

Sensory experiences are crucial for brain development, particularly in preterm infants. In utero, fetuses experience rhythmic multisensory input, but premature infants in the NICU often face sensory overload or under stimulation. These challenges can lead to sensory processing issues and increase the risk of neurodevelopmental problems, such as ADHD, ASD, and learning difficulties. Disruptions in sensory processing may result in Sensory Processing Disorder (SPD), affecting motor coordination, sensory discrimination, and emotional responses. Research shows that structured multisensory stimulation, including auditory, tactile, visual, and vestibular input, can benefit preterm infants’ neurodevelopment. Audio Tactile Visual Vestibular (ATVV) is a type of structured multisensory stimulation for premature infants. ATVV intervention focuses on sensory systems that are well developed in preterm infants and has positive behavioral and physiological findings. ATVV has shown positive effects, including improved alertness, feeding, weight gain, shorter hospital stays, and better developmental outcomes. It also strengthens parent-infant bonding and reduces maternal stress. In most studies, the interventions were administered by trained professionals. Administration by the mother will help implement the concept of family-centered care, empowering and involving the mother in vital interventions. The study aims to evaluate the effectiveness of parent administered ATVV program, on sensory processing, breastfeeding performance, post-partum bonding, weight gain, and length of hospital stay. This randomized controlled trial aims to evaluate the effectiveness of parent administered multisensory stimulation using the Auditory Tactile Visual Vestibular intervention (ATVV) on premature infants’ sensory processing, breastfeeding performance, and post-partum bonding in mothers, compared to usual care. Conducted at CMC Vellore’s NICU and CARING clinic, the study will involve 82 participants divided into intervention and control groups. Mothers in the intervention group will perform the ATVV procedure for three weeks, with assessments conducted at discharge and one year follow-up. The results will provide valuable insights into the effectiveness of parent administered sensory interventions on infant outcomes and parent bonding, helping to further develop intervention protocols.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
1.00 Day(s) 至 1.00 Year(s)(—)
性别
All

入选标准

  • from birth to 1-year corrected age follow up.

排除标准

  • Mothers with post-partum depression and known case of psychiatric comorbidities, mothers who are unable to breastfeed due to any medical condition, babies with major congenital abnormalities.

结局指标

主要结局

Sensory processing ability of infants using the Infant Sensory

时间窗: t1:3 weeks after intervention | t2:one year corrected age

Profile 2 (ISP-2)

时间窗: t1:3 weeks after intervention | t2:one year corrected age

次要结局

  • Breastfeeding performance(Post-partum bonding in mothers)

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Aruna R

Christian Medical College

研究点 (1)

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