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临床试验/NCT05001334
NCT05001334Unknown不适用

Evaluating the Efficiency of Kangaroo Care on Physiological Weight Loss in Term Newborns by Means of Number of Feedings, Number of Diapers and Periodic Weight Measurements

Istanbul University2 个研究点 分布在 2 个国家目标入组 102 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
102
试验地点
2
主要终点
Physiological weight loss evaluation

研究概览

简要总结

The aim of the study is to evaluate the effect of kangaroo care on physiological weight loss in term newborns.

详细描述

The data collection process continues in a randomized controlled experimental study conducted to determine the effect of kangaroo care on physiological weight loss in term newborns. In the calculation made for the determined effect size, 80% power, 5% margin of error and one-way statistical significance, the experimental group was planned as 51 and the control group as 51 newborns. In this reporting period, 25 newborns as the experimental group and 30 newborns as the control group were followed up and interviewed with the mother.

Mothers who meet the criteria to participate in the research are informed about the research in the delivery room or in the first hours of delivery. The mothers of the experimental group who accept to participate in the research are given training on how to make kangaroo care and what to pay attention to.

Breastfeeding of the mother, the number and frequency of bottle feeding, kangaroo care, diuresis, defecation numbers and weight are recorded by following up. Physiological weight losses are determined by comparing birth weight with daily weight losses.

A cotton kangaroo care blanket is given to every mother who agrees to participate in the study, so that mothers can care for their kangaroos comfortably and to continue kangaroo care at home. These covers, prepared for kangaroo care, increase the motivation of mothers to participate in the study. In order to facilitate the follow-up of diuresis and defecation numbers, the family is supported in the evaluation of diapers (number, weight).

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
— 至 1 Week(Child)
性别
All
接受健康志愿者

入选标准

  • Term babies born between 37-42 weeks of gestation
  • Newborns born vaginally
  • Newborns with developed sucking and swallowing reflexes

排除标准

  • Newborns born with C-section
  • Newborns in need of NICU care
  • Preterm newborns (born <37 weeks of gestation)
  • Newborns in need of oxygen
  • Genetic or metabolic disease (of the baby) limiting breastfeeding
  • HIV (+) mother
  • Mother having a chronic disease that will affect breastfeeding
  • Mother using drugs that pass into the breastmilk and affect the baby
  • Presence of a medical problem that will prevent the mother and baby from staying together

结局指标

主要结局

Physiological weight loss evaluation

时间窗: 1 week

Physiological weight loss of term newborns whose mothers are trained about and perform kangaroo care, is theorised to be less than those who receive standard newborn care information. Periodical weight measurements will be recorded. To evaluate feeding efficiency, number of feedings and kangaroo care periods, changed diaper numbers will be evaluated.

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

Nuray Dilek

Nurse, MSc

Istanbul University

研究点 (2)

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