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临床试验/NCT03849248
NCT03849248Unknown不适用

The Effect of Maternal Scent on Nutrition and Development of Preterm Infants

American University of Beirut Medical Center2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2019年5月24日最近更新:
适应症

试验速览

阶段
不适用
入组人数
132
试验地点
2
主要终点
Salivary cortisol level

研究概览

简要总结

To study the effect of maternal scent on the oral feeding, behavior and stress level of premature infants hospitalized in the Neonatal intensive care unit and to assess its potential effect on their development at 18 to 24 months.

详细描述

Premature infants develop their sense of smell very early in the womb. After birth infants can recognize and distinguish the odor of their mother from their father and others. Premature infants are capable of smelling and they experience less pain and agitation when they smell their mother's milk; studies have shown that premature infants have better sucking and feeding, and they may go home earlier when they are exposed to the odor of breast milk. It is not known whether the same will happen if preterm infants are exposed to their mother's smell rather than the smell of the maternal milk.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
5 Days 至 10 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Mother of a baby who was born premature before completing 36 weeks of pregnancy
  • Baby between ages of 5-10 days
  • Medically stable baby
  • Baby already began feeding by mouth or by feeding tube

排除标准

  • Medically unstable baby born after 36 weeks of gestation.

结局指标

主要结局

Salivary cortisol level

时间窗: Two years

The saliva will be collected from infant mouth after enrollment the first day before placing the scented cloth under the infant's head and the second after the exposure to the second cloth. Levels will be compared before and after and between groups.

次要结局

  • Physiological parameters: Heart rate and respiratory rate(Two years)
  • Achievement of oral feeding(Two years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Lama Charafeddine

Associate Professor of Pediatrics and Neonatology

American University of Beirut Medical Center

研究点 (2)

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