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临床试验/NCT05338203
NCT05338203Unknown不适用

Comparison of Breast Milk Contents in Tandem Breastfeeding and Non-Tandem Breastfeeding Mother

Gazi University2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2022年4月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
36
试验地点
2
主要终点
change in protein levels

研究概览

简要总结

Breastfeeding is the gold standard for feeding newborns and infants. Tandem breastfeeding is defined as breastfeeding during pregnancy or simultaneous breastfeeding of two non-twins. The aim of this study; The aim of this study is to compare breast milk contents of mothers who breastfeed in tandem and mothers who do not breastfeed in tandem. The study was planned as an experimental study with a single center control group. The place where the research will be conducted is the Lactation/Relactation outpatient clinic and gynecology and obstetrics polyclinic of Çamlıca Medipol University Hospital and Halil Şıvgın Çubuk State Hospital. and tandem non-breastfeeding mothers. Power analysis was performed to determine the number of samples. For this purpose, the study results of Rosenberg et al. (2021) (Experiment: 8.1±0.2 Control:6.2±1.5) were used as reference. According to the power analysis made by calculating the effect size, the sample size calculated with α= 0.01 error level and 99% power; 18 women in the experimental group and 18 women in the control group, a total of at least 36 women. The analysis was made in G*Power version 3.1.9.4. All mothers will be informed about the study, and mothers who accept the study will have to fill out the "Conformity to Criteria Form" created by the researchers. Written informed consent will be obtained from mothers who meet the research criteria. After completing the introductory information form, milk will be collected from all mothers. Milk collection will be done by one of the researchers. Milking will always be collected from all mothers between 08:00 and 16:00, provided that at least 40 minutes have passed after the last milking. Manual milking will be done for 10 minutes.

详细描述

There are studies on the concentration of macronutrients in breast milk in the literature A few studies have examined macronutrients in breast milk in mothers who breastfeed in tandem. Sinkiewicz-Darol et al. (2021) in his study; Macronutrients in breast milk in mothers who breastfeed in tandem have been studied. Breast milk during tandem breastfeeding had higher fat content, energy value, and total protein concentration than milk after weaning the older child. The carbohydrate content remained constant. In the study of Rosenberg et al., (2021), the concentration of macronutrients in breast milk was investigated in tandem breastfeeding and non-tandem breastfeeding mothers. As a result, it was determined that breast milk produced during pregnancy has different macronutrient content than breast milk produced after birth. It was determined that colostrum and mature milk of mothers who breastfed in tandem were similar to the milk of mothers who did not breastfeed in tandem, except for the carbohydrate content. Breastfeeding and tandem breastfeeding during pregnancy have not been extensively studied. For this reason, our study will determine the effect of tandem breastfeeding on the macronutrient content of breast milk and will provide evidence for tandem breastfeeding, which is traditionally practiced by many women.

1.2 Purpose of Research The aim of this study; The aim of this study is to compare the breast milk contents of tandem breastfeeding and non-tandem breastfeeding mothers.

  1. METHODS and MATERIALS 2.1. Type of Research The research was planned as an experimental study with a single center control group.

2.2. Place of Research The place where the research will be carried out is the Lactation/Relactation polyclinic and gynecology and obstetrics polyclinic of Çamlıca Medipol University Hospital and Halil Şıvgın Çubuk State Hospital.

2.3. Sample of the Research The population of the study will be tandem breastfeeding and non-tandem breastfeeding mothers who applied to the Lactation/Relactation outpatient clinic of Çamlıca Medipol University Hospital and Halil Şıvgın Çubuk State Hospital, and the obstetrics and gynecology outpatient clinics. Power analysis was performed to determine the number of samples. For this purpose, the study results of Rosenberg et al. (2021) (Experiment: 8.1±0.2 Control:6.2±1.5) were used as reference. According to the power analysis made by calculating the effect size, the sample size calculated with α= 0.01 error level and 99% power; 18 women in the experimental group and 18 women in the control group, a total of at least 36 women. The analysis was performed in G*Power version 3.1.9.4.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

change in protein levels

时间窗: 15 days

ıt wıll be analyzed from mılk

次要结局

  • change in carbonhidrad levels(15 days)
  • change in energy levels(15 days)
  • change in ph levels(15 days)
  • change in fat levels(15 days)

研究者

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

Sidika Pelit Aksu

Research asistant (RN)

Gazi University

研究点 (2)

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