NCT04506541

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 10, 2020

Completed
Last Updated

August 10, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

August 3, 2020

Last Update Submit

August 7, 2020

Conditions

Keywords

kangaroo caregrowthdevelopmentbreastfeedingmaternal attachment

Outcome Measures

Primary Outcomes (6)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Kangaroo Care Group

EXPERIMENTAL

The pregnant women who were in the kangaroo care group of the study and who were 36-38 weeks of gestation were given 20 minutes of kangaroo care and breastfeeding training by the researcher. A video about "kangaroo care and breastfeeding" was sent to pregnant women to remind them two weeks after the training. 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. In the first, third, sixth, and ninth months after the discharge of the mothers who started applying kangaroo care, kangaroo care application status, breastfeeding status, baby's growth, and development status were evaluated. In each follow-up, the baby's height, weight, and head circumference were measured with a standard measuring tool.

Other: Kangaroo Care

Control Group

NO INTERVENTION

The pregnant women in the control group were not trained other than breastfeeding training given in the hospital. In the maternity room, routine care practices were performed after delivery of the pregnant women. As in mothers in the kangaroo care group, in the first, third, sixth, and ninth months after the discharge of mothers, kangaroo care application situations, breastfeeding conditions, growth, and development of the baby were evaluated.

Interventions

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.

Kangaroo Care Group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ege University

Bornova, İzmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Patient PositioningPatient CareTherapeuticsInfant CareChild CareHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Rabia GENÇ

    Ege University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 3, 2020

First Posted

August 10, 2020

Study Start

March 1, 2017

Primary Completion

February 1, 2018

Study Completion

February 1, 2019

Last Updated

August 10, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations