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Clinical Trial Summary

Kangaroo care is a developmental care method determined to improve the quality of life of premature babies. When the benefits of kangaroo care on development and feeding with breast milk on premature babies are considered, term babies should also receive kangaroo care, and kangaroo care should be started immediately after birth. In this research, the authors aimed to investigate the effect of kangaroo care at birth on breast milk only feeding status and infant growth and development according to attachment theory. This is a randomized controlled, experimental, prospective study. The sample of the study consisted of pregnant women between 36-38 gestational weeks, who referred to the pregnant outpatient clinic of Buca Maternity and Children Hospital between March 2017 and February 2019 (n: 132). Pregnant women in the intervention group received "kangaroo care and breastfeeding training," and their babies were given kangaroo care at birth. Routine care was given to the mothers and their babies in the control group. Maternal attachment levels of mothers in both groups after birth and infants' breastfeeding only status and infant growth and development in the first, third, sixth, and ninth months were evaluated.


Clinical Trial Description

The research is a randomized controlled, experimental, prospective study conducted to examine the effect of kangaroo care at birth on feeding with breast milk only and nutritional status and growth-development of the baby according to attachment theory. The research was carried out at the Republic of Turkey, Ministry of Health, Izmir Provincial Health Directorate, Buca Women Birth and Child Diseases Hospital. The population of the study consisted of all pregnant women who were between 36-38 weeks of gestation and referred to the pregnant outpatient clinic between March 2017 and February 2019 (N.8079).Power analysis was carried out to determine the sample group that would represent the population in the research. In the power analysis, the sample was determined by evaluating the reference studies related to the feeding rate of only with breast milk in the first nine months, and the expected growth development level in the first nine months, which were the dependent variables of the research. For the first nine months, the 2.4% value stated in TNSA 2013 regarding feeding with breast milk rate was taken as reference (TNSA, 2013). Studies of Çelik et al. (2014) were taken as reference for the evaluation of growth and development. The number of samples to be taken for each group was determined as a result of the power analysis made according to these values. As a result of the evaluation made with power analysis, the expected effect factor with growth and development was calculated as two-times. Accordingly, it was determined that 48 samples should be taken for each group. Forecasting that data loss may occur in multi-monitoring studies, more than 10% of the sufficient sample size was included in the study (n: 214). The sample of the study consisted of pregnant women who applied to the Ministry of Health, Izmir Provincial Health Directorate, Buca Women Birth and Child Diseases Hospital pregnant outpatient clinic between March 2017 and February 2019, who were between 36-38 weeks of gestation and who met the inclusion criteria (n:132). After determining the sample number of the research, it was decided to make randomization according to the last numbers of the pregnant women's protocol numbers, and to which group the odd and even numbers would be included was determined by the method of a draw. As a result of the draw, the last digit of the protocol number ending with an odd number was included in the control group, the last digit of the protocol number, ending with an even number, was included in the intervention group ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04506541
Study type Interventional
Source Ege University
Contact
Status Completed
Phase N/A
Start date March 1, 2017
Completion date February 1, 2019

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