Kangaroo Mother CareMother CareNCT06863753
The Effect of Kangaroo Mother Care on Breastfeeding Success in The Early Postpartum Period
A study testing Kangoroo mother care in people with Kangaroo Mother Care, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study was to determine the effect of kangaroo mother care on breastfeeding success in the early postpartum period. The secondary aim was to determine the effect of kangaroo mother care on the vital signs of the mother and the baby. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Kangaroo Mother Care
- What is being tested?
- Kangoroo mother care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 31 May 2025to 31 May 2025
- 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 18 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over 18 years of age
- Agree to participate in the survey (those who signed the Informed Consent Form)
- Having had their first or second normal birth
- Being literate
- Having no communication problems
- Being a singleton pregnancy
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- Having a gestational age of 37-42 weeks
- Being open to communication and cooperation
- Having an intact family unit
- Birth weight 2500-4000 gr. between
- Born by normal delivery
- APGAR score of 7 and above at 1 and 5 minutes
- No health problems or congenital anomalies
- Born between 37 and 42 weeks of pregnancy
Who cannot join
- Being under 18 years of age
- Do not agree to participate in the study
- Not being able to read or write
- Having more than two babies
- Having breast problems that prevent breastfeeding
- Being born by Caesarean section
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- Having a diagnosed mental or psychological disorder
- Weighing less than 2500 grams
- Weighing more than 4000 grams
- Being born by Caesarean section
- APGAR score of less than 7 at 1 and 5 minutes
- Being born with a congenital anomaly
- Born before 37 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Kangaroo Mother Care on Breastfeeding Success in The Early Postpartum Period: Randomized Controlled Study
The primary aim of this study was to determine the effect of kangaroo mother care on breastfeeding success in the early postpartum period. The secondary aim was to determine the effect of kangaroo mother care on the vital signs of the mother and the baby.
Read the detailed description
From the selected sample, assignments to the intervention and control groups will be made by stratified block randomization method and randomizer.org website. Since it is predicted that mothers' previous breastfeeding experiences may affect breastfeeding success, mothers will be stratified in terms of the number of births (first vaginal birth/ two vaginal births). After stratification, block randomization will be performed and mothers will be assigned to the intervention and control groups with similar characteristics.
- Conditions
- Kangaroo Mother Care
- Being tested
- Kangoroo mother care
- Keywords
- Kangaroo mother care, Breastfeeding, Kangaroo care, Skin-to-skin contact
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kangoroo mother careOther
Kangaroo mother care will be practiced once, when the service, mother and baby are available, and then the training will be given. For skin-to-skin contact, the newborn will be laid naked on the mother's bare chest in the prone position, the newborn's abdomen and chest will be in contact with the mother's skin. Subsequently, the newborn's head will be turned to the side so that the airway remains open. The newborn will stay in this position for at least 45 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo mother care | Experimental | The practice will take place in the mother and baby's room. Mother and baby will be prepared for the practice. Kangaroo mother care will be provided once, when the service, mother and baby are available, and then the practice will be performed. For skin-to-skin contact, the newborn will be laid naked on the mother's bare chest in the prone position, the newborn's abdomen and chest will be in contact with the mother's skin. Subsequently, the newborn's head will be turned to the side so that the airway remains open. The newborn will stay in this position for at least 45 minutes. Receives: Other: Kangoroo mother care |
| Control | No intervention | No intervention will be made to the control grup, only the data will be collected at the same time as the study group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LATCH Breastfeeding and Diagnostic Scale mean scores
This measurement tool consists of five items. The name of the diagnostic tool, LATCH, is formed from the first letters of these five criteria in English.
- L, Latch on the breast;
- A, Audible swallowing;
- T, Type of the nipple;
- C, Comfort breast/nipple of the mother;
- H, Hold/Help position of the baby. Each item is evaluated between 0-2 points. The total score that can be obtained from the scale is 10, and a high score means high breastfeeding success.
Measured: Baseline and 60th minute
Secondary outcomes (8)
Vital signs of babies
Body temperature
Measured: Baseline and 60th minute
Vital signs of mothers
Body temperature
Measured: Baseline and 60th minute
Vital signs of babies
Respiratory rate
Measured: Baseline and 60th minute
Vital signs of babies
Oxygen saturation
Measured: Baseline and 60th minute
Vital signs of babies
Heart rate
Measured: Baseline and 60th minute
Vital signs of mothers
Respiratory rate
Measured: Baseline and 60th minute
Vital signs of mothers
Oxygen saturation
Measured: Baseline and 60th minute
Vital signs of mothers
Heart rate
Measured: Baseline and 60th minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2025
- Study start31 May 2025
- Primary completion31 May 2025
- Study completion31 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kangaroo Mother CareStudies of the same condition, open and under way.
- More trials run by Mersin 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
- Model description
- Prospective, Clinical trial with randomized control
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülhan VAROL, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06863753
- Sponsor's protocol ID
- MEU-HEM-GV-220
- Acronym
- Mother Care
- Status last verified
- Jun 2025
- First submitted
- 5 Jan 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Kangaroo Mother Care on Breastfeeding Success in The Early Postpartum Period: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06863753
- Acronym / sponsor ID
- Mother Care / MEU-HEM-GV-220
- Conditions
- Kangaroo Mother Care
- Keywords
- Kangaroo mother care, Breastfeeding, Kangaroo care, Skin-to-skin contact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 31 May 2025 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 7 Mar 2025 (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.
The primary aim of this study was to determine the effect of kangaroo mother care on breastfeeding success in the early postpartum period. The secondary aim was to determine the effect of kangaroo mother care on the vital signs of the mother and the baby.
Detailed description
From the selected sample, assignments to the intervention and control groups will be made by stratified block randomization method and randomizer.org website. Since it is predicted that mothers' previous breastfeeding experiences may affect breastfeeding success, mothers will be stratified in terms of the number of births (first vaginal birth/ two vaginal births). After stratification, block randomization will be performed and mothers will be assigned to the intervention and control groups with similar characteristics.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, Clinical trial with randomized control
| Arm | Type | Receives |
|---|---|---|
| Kangaroo mother care | Experimental | Other: Kangoroo mother careThe practice will take place in the mother and baby's room. Mother and baby will be prepared for the practice. Kangaroo mother care will be provided once, when the service, mother and baby are available, and then the practice will be performed. For skin-to-skin contact, the newborn will be laid naked on the mother's bare chest in the prone position, the newborn's abdomen and chest will be in contact with the mother's skin. Subsequently, the newborn's head will be turned to the side so that the airway remains open. The newborn will stay in this position for at least 45 minutes. |
| Control | No intervention | –No intervention will be made to the control grup, only the data will be collected at the same time as the study group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
Key exclusion criteria (13 listed)
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 |
|---|---|---|
| Kangoroo mother careKangaroo mother care will be practiced once, when the service, mother and baby are available, and then the training will be given. For skin-to-skin contact, the newborn will be laid naked on the mother's bare chest in the prone position, the newborn's abdomen and chest will be in contact with the mother's skin. Subsequently, the newborn's head will be turned to the side so that the airway remains open. The newborn will stay in this position for at least 45 minutes. | Other | Kangaroo mother care |
Primary outcome
LATCH Breastfeeding and Diagnostic Scale mean scores
Time frame: Baseline and 60th minute
This measurement tool consists of five items. The name of the diagnostic tool, LATCH, is formed from the first letters of these five criteria in English. * L, Latch on the breast; * A, Audible swallowing; * T, Type of the nipple; * C, Comfort breast/nipple of the mother; * H, Hold/Help position of the baby. Each item is evaluated between 0-2 points. The total score that can be obtained from the scale is 10, and a high score means high breastfeeding success.
8 secondary outcomes
Vital signs of babies
Time frame: Baseline and 60th minute
Vital signs of mothers
Time frame: Baseline and 60th minute
Vital signs of babies
Time frame: Baseline and 60th minute
Vital signs of babies
Time frame: Baseline and 60th minute
Vital signs of babies
Time frame: Baseline and 60th minute
Vital signs of mothers
Time frame: Baseline and 60th minute
Vital signs of mothers
Time frame: Baseline and 60th minute
Vital signs of mothers
Time frame: Baseline and 60th minute
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 4 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Kangaroo Mother Care
Active, not recruiting
Maternal Sensory Interventions in Newborns
Neonatal Intensive Care Unit, Hospitalized Newborn
Recruiting
Admission to Kangaroo Mother Care (KMC) Ward and Maternal Postpartum Depression
Low Birth Weight, Kangaroo Mother Care
Active, not recruiting
Effect of Kangaroo Mother Care on Energy Utilization in Preterm Neonates
Impact of Kangroo on Neonates
Not yet recruiting
EFFECT OF KANGAROO MOTHER CARE ON HOSPITAL OUTCOME IN LOW BIRTH WEIGHT
Low Birth Weight Among Neonates
Not yet recruiting
Effectiveness of Simulation-based Training Delivered to Special Newborn Care Providers on Resuscitation Management and Kangaroo Mother Care: Simulation-based Training for Asyphxia in Babies Trial (STAR-Baby Trial)
Newborn Asphyxia, Hypothermia Neonatal
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kangoroo mother care in people with Kangaroo Mother Care, run by Mersin 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 14 inclusion and 13 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 4 Jun 2025. 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?
LATCH Breastfeeding and Diagnostic Scale mean scores (time frame: Baseline and 60th minute). 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 4 Jun 2025.