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临床试验/NCT04252547
NCT04252547招募中不适用

The Effect Of Kangaroo Mother Care On Test Weighing In Preterm Infants

Istanbul University - Cerrahpasa2 个研究点 分布在 2 个国家目标入组 46 人开始时间: 2024年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
46
试验地点
2
主要终点
Test Weighing

研究概览

简要总结

The study will be conducted with the Crossover Randomized Controlled Method. The infants who have attained oral feeding in the neonatal intensive care unit will be divided into two groups via randomization in the computer environment. After the randomization, kangaroo care will be applied to the infants in Group 1 during the first feeding hour when they are included in the study and they will be breastfed by their mothers without any other application during the next feeding. On the other hand, no application will be performed on the infants in Group 2 during the first feeding hour when they are included in the study and kangaroo care will be applied to them during the second feeding hour. The infants in both groups will be breastfed by their mothers during the feeding hours.

详细描述

Test weighing is a feeding evaluation method which is used for evaluating the increase in infant's body weight and the amount of food intake before and after breastfeeding. Each gram is evaluated to be equivalent to one cc breast milk. The aim of the study is to evaluate the effect of kangaroo care applied to the preterm infants that have attained oral feeding and are breastfed by their mothers, on their physiological parameters, feeding condition and body weight increase. After weighing the infant only in his/her diaper before the feeding and applying kangaroo care in which skin-to-skin contact will be provided for half an hour, the mother will breastfeed the infant. The infant will be weighed once again after the feeding without diaper change and the effect of kangaroo care on test weighing and physiological parameters during the feeding process will be evaluated. Sample size of the study has been determined by the power analysis, in line with the results obtained from the studies which have been conducted using a similar research method. According to the analysis results, it has been calculated as 23 for each group and 46 in total. Parents of the infants meeting the study inclusion criteria will be informed both in written and verbally and then the study will be conducted with mothers who agree to participate in the study with their infants.

研究设计

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

入排标准

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

入选标准

  • - Agreeing to participate in the study for parents.
  • The inclusion criteria for infants were as follows;
  • Attaining to oral feeding by the physician in the neonatal intensive care unit
  • Being born at 26-36+6 gestational week which is determined according to the mother's last period cycle
  • Being at 32-39+6 postmenstrual week during the time they are included in the study
  • Having body weight of 1500 grams and above
  • Being breastfed at least once
  • Having no health problems other than being preterm

排除标准

  • The exclusion criteria for infants were as follows;
  • Suffering from gastrointestinal, neurological or genetic diseases (such as necrotizing enterocolitis, intracranial bleeding, hydrocephalia, omphalocele, down syndrome, gastroschisis) and other diseases
  • Having a condition obstructing oral feeding (such as cleft palate, cleft lip, facial muscle paralysis, craniofacial abnormalities etc.)
  • Receiving oxygen support

结局指标

主要结局

Test Weighing

时间窗: Change the body weight before feeding to after feeding at 1 day

The infants' body weight before and after feeding will be measured using an 'Infant Scale'. The infants will be weighed naked only in their diaper before and after feeding, in order to evaluate the amount of milk they have received from their mothers' breast.

次要结局

  • Oxygen Saturation(Change the Oxygen Saturation 10 minutes before feeding to 2 minutes after feeding)
  • Heart Rate(Change the Heart Rate 10 minutes before feeding to 2 minutes after feeding)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Canan Genç

RN, Principal Investigator

Istanbul University - Cerrahpasa

研究点 (2)

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