Effect of Kangaroo Care on Test Weighing

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Kangaroo Care
  The preprocedural measurements (weight, heart rate, and oxygen saturation) will be recorded before the first feeding hour when they are included in the study and then they will be held on their mothers' chest for skin-to-skin kangaroo care for half an hour. Their heart rate and oxygen saturation will be recorded for half an hour. At the end of the kangaroo care, the infant will be breastfed by his/her mother. A chronometer will be started at that moment he/she begins sucking and terminated when
• Другое Control
  The preprocedural measurements (weight, heart rate, and oxygen saturation) will be recorded before feeding when they are included in the study and then they will be breastfed by their mothers. The chronometer will be started at that moment he/she begins sucking and terminated when he/she stops. Also, the infant's heart rate and oxygen saturation will continue to be recorded during the breastfeeding process. When the breastfeeding process is over, the infant will be allowed to rest in his/her mot

Первичные конечные точки

• Test Weighing [Срок оценки: Change the body weight before feeding to after feeding at 1 day]

Вторичные конечные точки (2)

• Heart Rate [Срок оценки: Change the Heart Rate 10 minutes before feeding to 2 minutes after feeding]
• Oxygen Saturation [Срок оценки: Change the Oxygen Saturation 10 minutes before feeding to 2 minutes after feeding]

Критерии участия

Критерии включения

\- 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Istanbul Medipol University — Istanbul

Идентификаторы

NCT: NCT04252547 · 10840098-604.01.01-E.53511

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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