The Effects Of KC On Exclusively Breastfeeding And Baby's Growth And Development According To Attachment Theory

Breastfeeding, Exclusive Clinical Trial

Official title:

The Effects Of Birth Kangaroo Care On Exclusively Breastfeeding And Baby's Growth And Development According To Attachment Theory

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04506541
• Other study ID #: Kangaroo care at birth
• Status: Completed
• Phase: N/A
• Start date: March 1, 2017
• Est. completion date: February 1, 2019

Study information

• Verified date: August 2020
• Source: Ege University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: February 1, 2019
• Est. primary completion date: February 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

The inclusion criteria

• 36-38 gestational weeks,

• giving birth at 37 weeks or above,

• single and live fetus,

• having no obstacle for applying kangaroo care,

• accepting kangaroo care implementation,

• no need for intervention of newborn,

• no need of newborn to be referred to the neonatal intensive care unit,

• being able to communicate with the pregnant woman,

• having a cesarean section with spinal or epidural anesthesia.

Exclusion criteria

• being accepted to the delivery room with urgent delivery,

• mothers who did not want to apply kangaroo care,

• mothers who had mental disorders which could harm the baby or self such as postpartum depression,

• the delivery was performed under general anesthesia for pregnant women who had a cesarean delivery.

Related Conditions & MeSH terms

• Attachment
• Breastfeeding, Exclusive
• Development, Infant
• Growth Acceleration

Intervention

Other:
• Kangaroo Care
Kangaroo care application started in the first minute after giving birth in mothers who were in the kangaroo care group and came to the delivery room.

Locations

Country	Name	City	State
Turkey	Ege University	Bornova	Izmir

Sponsors (2)

Lead Sponsor	Collaborator
Ege University	Buca Women Birth and Child Diseases Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	breastfeeding conditions	Baby's time to start sucking: how many minutes in the first half hour it starts to suck Absorption time: How many minutes it absorbs in the first half hour; o Breastfeeding status only: Breastfeeding time of the mother's baby only until the end of the research by using Kangaroo Care and Breastmilk Intake Status Inspection Form. The form was developed by the researcher to monitor and control how long the mother implemented the kangaroo care, the time baby started breastfeeding, the duration of breastfeeding, and the changes in the baby's body weight	from birth to the ninth month
Primary	baby's weight	the weight of the baby was evaluated in grams and was measured with a standard measuring tool.	from birth to the ninth month
Primary	baby's height	the height of the baby was evaluated in centimeter and was measured with a standard measuring tool.	from birth to the ninth month
Primary	baby's head circumferecne	the head circumference of the baby was evaluated in centimeter and was measured with a standard measuring tool.	from birth to the ninth month
Primary	baby's development	Baby's first, third, sixth and ninth month developmental status by using Guide to Monitoring and Supporting Development. There is no scoring in the development monitoring and supporting guide. In the study, the developmental status of the babies was categorized as "behind by month," "normal by month," and "ahead by month.	from birth to the ninth month
Primary	maternal attachment	Attactment level between mother and baby at postpartum first, third, sixth and ninth months by using Maternal Attachment Scale. The scale consists of 26 items in a four-point Likert type. The minimum score that can be obtained from the scale is 26, the maximum score is 104, and the height of the score indicates that the bond between the mother and the baby is high The Cronbach's alpha value of the scale was determined as 0.87 in the study.	from birth to the ninth month