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临床试验/NCT05928715
NCT05928715Enrolling By Invitation不适用

Effect of Finger Feeding on Term Newborns: A Randomized Controlled Study

Amasya University2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2023年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
140
试验地点
2
主要终点
Expressed breast milk

研究概览

简要总结

With the planned study, it was aimed to determine the effect of finger feeding method on newborns in term babies.

详细描述

It was planned as a randomized controlled experimental study design.

Full randomization will be performed and infants who meet the inclusion criteria will be assigned to groups by flipping a coin.

On the toss of a coin, if heads came up then subject was allocated to the control group. If tails came up, then subject was allocated to the intervention group. This procedure was repeated for each mother.

Within the scope of the study, "Informed consent" will be obtained from the parents for infants who need formula supplementation or for infants fed with expressed breast milk by the decision of the Physician in the experimental and control groups.

Babies in the control group will continue to receive routine care and no intervention will be made on their feeding style. The researcher will be informed verbally and practically about the finger feeding method and the application steps to the mothers of the babies in the experimental group and to the family members who will support their feeding in baby care. In this direction, it will be ensured that expressed breast milk or formula support is given by finger feeding method.

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
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Mother is 18 years or older Newborns 38 weeks and older Newborns who do not have any postnatal health problems and are followed up with the mother Babies taking formula supplements Babies who have difficulty breastfeeding There is no obstacle to breastfeeding or breastfeeding

排除标准

  • Babies with sucking and swallowing dysfunction Babies with respiratory distress (respiratory rate over 60/min, babies with groaning, nasal wing breathing)

结局指标

主要结局

Expressed breast milk

时间窗: 15 days after the start of the intervention

amount of daily expressed breast milk intake

finger feeding

时间窗: 15 days after the start of the intervention

number of finger feeding per day

Formula intake

时间窗: 15 days after the start of the intervention

amount of daily formula consumption

Breastfeeding

时间窗: 15 days after the start of the intervention

Number of breastfeeding per day

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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