Breastfeeding, ExclusiveNCT04506541
The Effects Of KC On Exclusively Breastfeeding And Baby's Growth And Development According To Attachment Theory
A study testing Kangaroo Care in people with Breastfeeding, Exclusive and Growth Acceleration, run by Ege University at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breastfeeding, Exclusive, Growth Acceleration, Development, Infant
- What is being tested?
- Kangaroo Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2017to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects Of Birth Kangaroo Care On Exclusively Breastfeeding And Baby's Growth And Development According To Attachment Theory
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.
Read the 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
- Being tested
- Kangaroo Care
- Keywords
- kangaroo care, growth, development, breastfeeding, maternal attachment
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangaroo CareOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: from birth to the ninth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2020
- Study start1 Mar 2017
- Primary completion1 Feb 2018
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breastfeeding, ExclusiveStudies of the same condition, open and under way.
- More trials run by Ege UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ege University
- Sponsor type
- University, hospital or other
- Collaborators
- Buca Women Birth and Child Diseases Hospital
- Responsible party
- Principal investigator, Emine Serap Sarıcan, Ege University
- Investigators
- Rabia GENÇ, Principal investigator, Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04506541
- Sponsor's protocol ID
- Kangaroo care at birth
- Status last verified
- Aug 2020
- First submitted
- 3 Aug 2020
- Last updated
- 10 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects Of Birth Kangaroo Care On Exclusively Breastfeeding And Baby's Growth And Development According To Attachment Theory
- ClinicalTrials.gov ID
- NCT04506541
- Acronym / sponsor ID
- Kangaroo care at birth
- Keywords
- kangaroo care, growth, development, breastfeeding, maternal attachment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Ege UniversityUniversity, hospital or other
- Collaborators
- Buca Women Birth and Child Diseases Hospital
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 1 Feb 2018 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 10 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kangaroo Care Group | Experimental | Other: Kangaroo CareThe 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. |
| 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. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Kangaroo CareKangaroo 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. | Other | Kangaroo Care Group |
Primary outcome
breastfeeding conditions
Time frame: from birth to the ninth month
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
baby's weight
Time frame: from birth to the ninth month
the weight of the baby was evaluated in grams and was measured with a standard measuring tool.
baby's height
Time frame: from birth to the ninth month
the height of the baby was evaluated in centimeter and was measured with a standard measuring tool.
baby's head circumferecne
Time frame: from birth to the ninth month
the head circumference of the baby was evaluated in centimeter and was measured with a standard measuring tool.
baby's development
Time frame: from birth to the ninth month
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.
maternal attachment
Time frame: from birth to the ninth month
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rabia GENÇ principal investigator
Ege University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangaroo Care in people with Breastfeeding, Exclusive and Growth Acceleration, run by Ege University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
breastfeeding conditions (time frame: from birth to the ninth month). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2020.