BreastfeedingNCT07543029
Kangaroo Care: Breastfeeding Success and Maternal Role
A study testing Kangaroo Mother Care in people with Breastfeeding and Maternal Role, run by Recep Tayyip Erdogan University at 1 site in Turkey (Türkiye).
Trial summary
Purpose: This is a randomized controlled trial designed to investigate the effects of Intermittent Kangaroo Mother Care (KMC) in the early postpartum period to primiparous mothers on breastfeeding success and the perception of the maternal role. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Maternal Role, Postpartum Care
- What is being tested?
- Kangaroo Mother Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 30 Jun 2026
- 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 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- For mothers:
- It must be the mother's first birth,
- Birth must have been vaginal,
- The mother must be healthy,
- The mother must voluntarily participate in the study,
- The mother must not have any communication-impairing conditions (language, cognitive problems, etc.),
Show all 13Show fewer
- For babies:
- Birth weight must be between 2500-4000 grams;
- The newborn must be healthy,
- Exclusively breastfeeding,
- The newborn must be at term gestation (38-42 weeks),
- The newborn's Apgar score at 1 and 5 minutes must be above 7,
- The newborn must not have any health problems that could affect breastfeeding (cleft palate, cleft lip, esophageal atresia, etc.).
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intermittent Kangaroo Care in the Early Postpartum Period to Primiparous Mothers on Breastfeeding Success and Perception of the Maternal Role
Purpose: This is a randomized controlled trial designed to investigate the effects of Intermittent Kangaroo Mother Care (KMC) in the early postpartum period to primiparous mothers on breastfeeding success and the perception of the maternal role.
Methodology and Sample:
Read more
Setting and Period: The study will be conducted at the Bucak State Hospital Delivery Unit between June 2025 and June 2026.
Sample Size: Based on G*Power analysis (alpha=0.05, power=80%, effect size d=0.548), a total of 108 mothers will be included, accounting for a 10% potential attrition rate. Participants will be assigned to groups using the sealed envelope method and randomization via www.random.org.
Intervention:
Experimental Group: Following routine care, the newborn will be placed in a "chest-to-chest" position on the mother's bare chest for intermittent Kangaroo Care. Intermittent KMC will be maintained for 24 hours, during which breastfeeding attempts will be supported.
Control Group: Mothers and newborns will receive only the hospital's routine care (standard skin-to-skin contact and breastfeeding support).
Data Collection Tools:
Personal Information Form, Semantic Differential Scale-Myself as a Mother (to measure maternal role perception), LATCH Breastfeeding Assessment Tool (to evaluate breastfeeding success).
Read the detailed description
Intervention Protocol:
Experimental Group: In addition to routine delivery care, newborns will receive Kangaroo Mother Care (KMC). The newborn, wearing only a diaper and a hat, will be placed in an upright "chest-to-chest" position on the mother's bare chest. The infant's head will be maintained in a neutral physiological position, and the back will be covered with a blanket. The first application was performed under the researcher's supervision to ensure that the mothers were performing kangaroo care correctly. Mothers performed their first kangaroo care session with the researcher's assistance and subsequent sessions under the researcher's supervision.
Control Group: Participants will receive the standard hospital protocol (routine skin-to-skin contact immediately after birth and standard neonatal care). No additional KMC intervention will be applied by the study team.
Data Collection and Measurement Points:Data collection will be conducted at two specific time points to evaluate the effectiveness of the intervention:Baseline (0 Hour): Immediately following the first breastfeeding attempt (within the first hour postpartum), the LATCH Breastfeeding Assessment Tool and Semantic Differansial Scale will be administered to both groups to establish baseline breastfeeding success and mathernal role.Post-Intervention (24th Hour): At the end of the 24th hour postpartum, the LATCH tool will be re-administered to evaluate the change in breastfeeding success. Additionally, the Semantic Differential Scale-Myself as a Mother will be administered at this time point to compare maternal role perception between the two groups.
Statistical Analysis: The normality of the data will be assessed using the Skewness and Kurtosis coefficients. For Breastfeeding Success: A Two-Way Mixed ANOVA will be used to analyze the interaction between "Group" (Experimental vs. Control) and "Time" (0 vs. 24 hours).For Maternal Role Perception: Since this variable is measured only at the 24th hour, an Independent Samples t-test (or Mann-Whitney U test, depending on normality) will be used for inter-group comparison.All analyses will be performed using SPSS 25.0 with a significance level of p < 0.05.
- Conditions
- Breastfeeding, Maternal Role, Postpartum Care, Kangaroo Care
- Being tested
- Kangaroo Mother Care
- Keywords
- Primiparity, newborn, breastfeeding, maternal role, kangaroo care
- 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 Mother CareBehavioural
Newborns will be placed in an upright chest-to-chest position on the mother's bare chest. This intermittent skin-to-skin contact will be applied in sessions according to the mother's and newborn's stability and comfort, and will be maintained at regular intervals throughout the first 24 hours postpartum.
| Study group | Role | What they receive |
|---|---|---|
| Kangaroo | Experimental | Mothers in this group will receive intermittent Kangaroo Mother Care (chest-to-chest contact) for 24 hours postpartum. Receives: Behavioral: Kangaroo Mother Care |
| Control | No intervention | Mothers in this group will receive standard hospital postpartum care protocols, including routine skin-to-skin contact and breastfeeding support. |
What is being measured
The primary outcome is the main question the study is designed to answer.
LATCH Breastfeeding Assessment Tool
Developed by Deborah Jehsen and Sheila Wallace in 1993 to assess breastfeeding, it consists of five parameters, each item scored between 0 and 2 points. The highest possible score on the scale is 10, and the lowest is 0. The validity and reliability of the LATCH Breastfeeding Assessment Tool in Turkey was determined by Yenal and Okumuş in 2003, and it was found to be valid and reliable for the Turkish population. The validity and reliability coefficient of the LATCH scale is alpha 0.82. The scale, consisting of 5 evaluation criteria, is formed by combining the first letters of the English words LATCH. The criteria are as follows; L: Latch on breast A: Audible swallowing T: Type of nipple C: Comfort breast/nipple. H: Baby holding position
Measured: 8 month
Semantic Difference Scale - Self-Assessment as a Mother
Developed by Walker et al. (1986), this scale was designed to measure the evaluation dimensions of the concept of "self-assessment as a mother." The adaptation of the scale to Turkish society was done by Çalışır (2003). The scale consists of 11 pairs of opposing adjectives, distributed among 22 items. Each adjective pair is scored from 1 to 7. Three items (3, 7, 8) are evaluated using a reverse scoring system to prevent biased scoring by participants. A high total score on the scale indicates a positive self-assessment of motherhood (Walker et al., 1986). While Walker found the internal consistency coefficient to be between 0.81-0.85, Çalışır found the Cronbach Alpha internal consistency coefficient to be between 0.73-0.74 (Çalışır, 2003).
Measured: 8 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2026
- Study start1 Jun 2025
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gamzegül ALTAY, Recep Tayyip Erdogan University
- Investigators
- Gamzegül ALTAY, PhD, Principal investigator, Recep Tayyip Erdogan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07543029
- Sponsor's protocol ID
- GA-E-40465587-050.01.04-1502
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly to protect participant privacy and maintain confidentiality in accordance with informed consent and ethical approval protocols.
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intermittent Kangaroo Care in the Early Postpartum Period to Primiparous Mothers on Breastfeeding Success and Perception of the Maternal Role
- ClinicalTrials.gov ID
- NCT07543029
- Acronym / sponsor ID
- GA-E-40465587-050.01.04-1502
- Conditions
- Breastfeeding, Maternal Role, Postpartum Care, Kangaroo Care
- Keywords
- Primiparity, newborn, breastfeeding, maternal role, kangaroo care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 21 Apr 2026 (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.
Purpose: This is a randomized controlled trial designed to investigate the effects of Intermittent Kangaroo Mother Care (KMC) in the early postpartum period to primiparous mothers on breastfeeding success and the perception of the maternal role.
Methodology and Sample:
Setting and Period: The study will be conducted at the Bucak State Hospital Delivery Unit between June 2025 and June 2026.
Sample Size: Based on G*Power analysis (alpha=0.05, power=80%, effect size d=0.548), a total of 108 mothers will be included, accounting for a 10% potential attrition rate. Participants will be assigned to groups using the sealed envelope method and randomization via www.random.org.
Intervention:
Experimental Group: Following routine care, the newborn will be placed in a "chest-to-chest" position on the mother's bare chest for intermittent Kangaroo Care. Intermittent KMC will be maintained for 24 hours, during which breastfeeding attempts will be supported.
Control Group: Mothers and newborns will receive only the hospital's routine care (standard skin-to-skin contact and breastfeeding support).
Data Collection Tools:
Personal Information Form, Semantic Differential Scale-Myself as a Mother (to measure maternal role perception), LATCH Breastfeeding Assessment Tool (to evaluate breastfeeding success).
Detailed description
Intervention Protocol:
Experimental Group: In addition to routine delivery care, newborns will receive Kangaroo Mother Care (KMC). The newborn, wearing only a diaper and a hat, will be placed in an upright "chest-to-chest" position on the mother's bare chest. The infant's head will be maintained in a neutral physiological position, and the back will be covered with a blanket. The first application was performed under the researcher's supervision to ensure that the mothers were performing kangaroo care correctly. Mothers performed their first kangaroo care session with the researcher's assistance and subsequent sessions under the researcher's supervision.
Control Group: Participants will receive the standard hospital protocol (routine skin-to-skin contact immediately after birth and standard neonatal care). No additional KMC intervention will be applied by the study team.
Data Collection and Measurement Points:Data collection will be conducted at two specific time points to evaluate the effectiveness of the intervention:Baseline (0 Hour): Immediately following the first breastfeeding attempt (within the first hour postpartum), the LATCH Breastfeeding Assessment Tool and Semantic Differansial Scale will be administered to both groups to establish baseline breastfeeding success and mathernal role.Post-Intervention (24th Hour): At the end of the 24th hour postpartum, the LATCH tool will be re-administered to evaluate the change in breastfeeding success. Additionally, the Semantic Differential Scale-Myself as a Mother will be administered at this time point to compare maternal role perception between the two groups.
Statistical Analysis: The normality of the data will be assessed using the Skewness and Kurtosis coefficients. For Breastfeeding Success: A Two-Way Mixed ANOVA will be used to analyze the interaction between "Group" (Experimental vs. Control) and "Time" (0 vs. 24 hours).For Maternal Role Perception: Since this variable is measured only at the 24th hour, an Independent Samples t-test (or Mann-Whitney U test, depending on normality) will be used for inter-group comparison.All analyses will be performed using SPSS 25.0 with a significance level of p < 0.05.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kangaroo | Experimental | Behavioral: Kangaroo Mother CareMothers in this group will receive intermittent Kangaroo Mother Care (chest-to-chest contact) for 24 hours postpartum. |
| Control | No intervention | –Mothers in this group will receive standard hospital postpartum care protocols, including routine skin-to-skin contact and breastfeeding support. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- For mothers:
- Birth weight must be between 2500-4000 grams;
- The newborn must be healthy,
- Exclusively breastfeeding,
- The newborn must be at term gestation (38-42 weeks),
Key exclusion criteria (1 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 |
|---|---|---|
| Kangaroo Mother CareNewborns will be placed in an upright chest-to-chest position on the mother's bare chest. This intermittent skin-to-skin contact will be applied in sessions according to the mother's and newborn's stability and comfort, and will be maintained at regular intervals throughout the first 24 hours postpartum. | Behavioural | Kangaroo |
Primary outcome
LATCH Breastfeeding Assessment Tool
Time frame: 8 month
Developed by Deborah Jehsen and Sheila Wallace in 1993 to assess breastfeeding, it consists of five parameters, each item scored between 0 and 2 points. The highest possible score on the scale is 10, and the lowest is 0. The validity and reliability of the LATCH Breastfeeding Assessment Tool in Turkey was determined by Yenal and Okumuş in 2003, and it was found to be valid and reliable for the Turkish population. The validity and reliability coefficient of the LATCH scale is alpha 0.82. The scale, consisting of 5 evaluation criteria, is formed by combining the first letters of the English words LATCH. The criteria are as follows; L: Latch on breast A: Audible swallowing T: Type of nipple C: Comfort breast/nipple. H: Baby holding position
Semantic Difference Scale - Self-Assessment as a Mother
Time frame: 8 month
Developed by Walker et al. (1986), this scale was designed to measure the evaluation dimensions of the concept of "self-assessment as a mother." The adaptation of the scale to Turkish society was done by Çalışır (2003). The scale consists of 11 pairs of opposing adjectives, distributed among 22 items. Each adjective pair is scored from 1 to 7. Three items (3, 7, 8) are evaluated using a reverse scoring system to prevent biased scoring by participants. A high total score on the scale indicates a positive self-assessment of motherhood (Walker et al., 1986). While Walker found the internal consistency coefficient to be between 0.81-0.85, Çalışır found the Cronbach Alpha internal consistency coefficient to be between 0.73-0.74 (Çalışır, 2003).
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 23 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly to protect participant privacy and maintain confidentiality in accordance with informed consent and ethical approval protocols.
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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.
Gamzegül ALTAY, PhD principal investigator
Recep Tayyip Erdogan 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 Mother Care in people with Breastfeeding and Maternal Role, run by Recep Tayyip Erdogan 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 13 inclusion and 1 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 23 Sep 2026. 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 Assessment Tool (time frame: 8 month). The study lists 2 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 23 Sep 2026.