Clinical trial NCT04506541: The Effects Of KC On Exclusively Breastfeeding And Baby's Growth And Development According To Attachment Theory
Official title: The Effects Of Birth Kangaroo Care On Exclusively Breastfeeding And Baby's Growth And Development According To Attachment Theory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding, Exclusive
Growth Acceleration
Development, Infant
Attachment
Keywords: kangaroo care
growth
development
breastfeeding
maternal attachment
Lead sponsor: Ege University
Sponsor class: OTHER
Collaborators: name: Buca Women Birth and Child Diseases Hospital
First posted: 2020-08-10
Enrollment: 214
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: breastfeeding conditions
timeFrame: from birth to the ninth month
measure: baby's weight
timeFrame: from birth to the ninth month
measure: baby's height
timeFrame: from birth to the ninth month
measure: baby's head circumferecne
timeFrame: from birth to the ninth month
measure: baby's development
timeFrame: from birth to the ninth month
measure: maternal attachment
timeFrame: from birth to the ninth month
Secondary outcomes:
Other outcomes:
Locations:
city: Bornova
country: Turkey
facility: Ege University
state: İzmir
Study officials:
affiliation: Ege University
name: Rabia GENÇ
role: PRINCIPAL_INVESTIGATOR
References: