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临床试验/NCT05181020
NCT05181020已完成不适用

Studying the Influence of Exposure to Maternal Voice on Oral Feeding Volumes in Preterm Infants

Connecticut Children's Medical Center2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2020年6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
已完成
入组人数
25
试验地点
2
主要终点
Oral feeding volume

研究概览

简要总结

Oral feeding is one of the primary functions of the neonatal brain. In preterm infant population, competency at oral feeding is one of the major milestones in preparation for discharge. Mother's voices have been shown to have a net stimulatory effect and premature infants have been found to have increased cardiorespiratory stability after listening to mother's voices. Main objective of this study is to determine if it is possible to expose preterm infant in a systematic manner to mother's voices before their feeds and to determine if this exposure results in an increase in their oral intake.

详细描述

Achievement of full oral feedings is directly associated with length of neonatal intensive care unit stay. Extremely low gestational age infants with dysfunctional oral feeding in early childhood have lower cognitive and language skills compared with those with normal oral feedings. Also, previous studies have shown a strong association between oral feeding and infant maturity and behavior state and positive feeding experience. In recent years, there is emerging evidence that non-medical developmental care interventions in the neonatal intensive care units such as kangaroo care, single family rooms, and music and massage therapy may be beneficial for preterm infants and improve their long term neurodevelopmental outcomes. Beneficial effects of exposure to mother's voice and sounds on preterm infants in the neonatal intensive care units are well documented. Our study proposes to examine the association between exposure to mother's voice prior to and during oral feeding and oral feeding volume and rate in preterm infants.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
28 Weeks 至 40 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Preterm infants born between gestational age of 28 0/7 weeks and 34 6/7 weeks
  • Ready to start oral feeding attempts
  • Taking a total daily oral intake < 50% of feeds on average in 2 days prior to starting intervention
  • Mothers who are English speaking and over 18 years old

排除标准

  • Major congenital anomalies
  • Non-English speaking
  • Family history of suspected congenital hearing loss
  • Failed hearing test in NICU
  • Grade three to four intraventricular hemorrhage or periventricular leukomalacia
  • necrotizing enterocolitis requiring treatment
  • Congenital infections such as cytomegalovirus which can lead to sensorineural hearing loss

研究组 & 干预措施

Maternal Voice Exposure

Experimental

Infants enrolled will be exposed to maternal voice for 20 min immediately prior to being offered oral feedings. This exposure will be conducted 2 times a day until infant starts taking all enteral feeds orally.

干预措施: Maternal Voice Exposure (Behavioral)

结局指标

主要结局

Oral feeding volume

时间窗: Through study completion, average 40 weeks post menstrual age

Effect of maternal voice immediately prior to feeding on oral feeding volumes in preterm infants

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

Shabnam Lainwala

Principal Investigator, Attending Neonatologist

Connecticut Children's Medical Center

研究点 (2)

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