Amount of Breast MilkNCT06125548
Care Based on the Lactation Management Model Provided to Mothers With Babies in the Intensive Care Unit
A study testing Lactation Management Model in people with Amount of Breast Milk, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
Using breast stimulating techniques (skin-to-skin contact, relaxation exercises, breast massage, nipple stimulation, hot application, etc.) stimulates the secretion of milk and increases its amount. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Amount of Breast Milk
- What is being tested?
- Lactation Management Model
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2022to 10 Jan 2023
- 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 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18-35,
- The baby is still in intensive care,
- Gave birth at 34 weeks of gestation and above,
- The baby was taken to intensive care within the first 3 days after birth,
- The baby will stay in the neonatal intensive care unit for at least 3 more days,
- The baby has started breastfeeding,
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- Giving breast milk to the baby by expressing it,
- Not using any medication that will affect milk quantity,
- Does not have a psychiatric disease that will affect breastfeeding in the postpartum period,
- Availability by phone, language, etc. Mothers who do not have communication problems.
Who cannot join
- Not between the ages of 18-35,
- The baby is discharged from intensive care,
- Those whose gestational age is less than 34 weeks,
- The baby is taken to intensive care after the first 3 days after birth,
- The baby is in the neonatal intensive care unit for at least 3 days,
- The baby has not started breastfeeding,
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- Breastfeeding,
- Those who use medication that will affect the amount of milk,
- Having a psychiatric disease that will affect breastfeeding in the postpartum period,
- Mothers with communication problems.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lactation Management Model-Based Care Provided to Mothers With Babies in the Intensive Care Unit on the Amount of Breast Milk and Breastfeeding Duration
Using breast stimulating techniques (skin-to-skin contact, relaxation exercises, breast massage, nipple stimulation, hot application, etc.) stimulates the secretion of milk and increases its amount. This study aimed to determine the effect of care based on the lactation management model offered to mothers whose babies are in the neonatal intensive care unit, on the amount of breast milk and duration of breastfeeding.
Read the detailed description
Support of prolactin and oxytocin hormones is needed for adequate production and secretion of breast milk. Many factors affect the levels of oxytocin and prolactin in the blood, such as the health status of the mother and the baby after birth, their separation for a while, nutrition, light, stress, fear, and lack of social support. Using breast stimulating techniques (skin-to-skin contact, relaxation exercises, breast massage, nipple stimulation, hot application, etc.) stimulates the secretion of milk and increases its amount. This study aimed to determine the effect of care based on the lactation management model offered to mothers whose babies are in the neonatal intensive care unit, on the amount of breast milk and duration of breastfeeding.
- Conditions
- Amount of Breast Milk
- Being tested
- Lactation Management Model
- Keywords
- Breastfeeding, Lactation Management Model, Breast Milk, Neonatal Intensive 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.
Lactation Management ModelOther
The mother provides skin-to-skin contact to her baby 12 times a day, 8 times on the 2nd day, 4 times on the 3rd day, hot application to the breast (5 minutes), relaxation technique (3 minutes) and breast massage (5 minutes by hand milking, 2 minutes by breast massage). Head stimulation, stroking for 3 minutes) were asked.
| Study group | Role | What they receive |
|---|---|---|
| Lactation Management Model-Experimental | Experimental | The women in the experimental group were told about the care technique in accordance with the Lactation Management Model and were asked to apply it regularly for 3 days.The content of the Lactation Management Model includes skin-to-skin contact, hot application to the breast, relaxation and breast massage, and process monitoring.In this regard, the mother should apply skin-to-skin contact to her baby 12 times a day, 8 times on the 2nd day, 4 times on the 3rd day, hot application to the breast (5 minutes), relaxation technique (3 minutes) and breast massage (5 minutes manual milking, 2 minutes . nipple stimulation, stroking for 3 minutes). Receives: Other: Lactation Management Model |
| Non-application group- Control | No intervention | No treatment was performed on women in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Scoring system for the amount of breast milk the baby receives
The form developed to evaluate the amount of breast milk the baby receives consists of 5 sections: urine amount, breast condition, stool amount, weight and satisfaction. Each section is grouped into 3 groups in terms of its features and is evaluated over 0, 1, 2 points. In the evaluation, 10 points mean that breast milk is received in the best way, and 7 points and below mean that breast milk is inadequate.
Measured: Change from before implementation and 4th week of practice
Secondary outcomes (1)
Breast Milk and Breastfeeding Monitoring Form
It is a form consisting of 5 questions about breastfeeding (2 questions), breast milk (2 questions) and baby's weight (1 question), developed by the researcher in line with the literature.
Measured: Change from before implementation and 4th week of practice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start10 Jan 2022
- Primary completion1 Sep 2022
- Study completion10 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amount of Breast MilkStudies 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 RANDOMIZED CONTROLLED STUDY
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aslı EKER, Mersin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06125548
- Sponsor's protocol ID
- Mersin University Midwifery
- Status last verified
- May 2025
- First submitted
- 4 Nov 2023
- Last updated
- 9 May 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 9 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lactation Management Model-Based Care Provided to Mothers With Babies in the Intensive Care Unit on the Amount of Breast Milk and Breastfeeding Duration
- ClinicalTrials.gov ID
- NCT06125548
- Acronym / sponsor ID
- Mersin University Midwifery
- Conditions
- Amount of Breast Milk
- Keywords
- Breastfeeding, Lactation Management Model, Breast Milk, Neonatal Intensive Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 10 Jan 2023 (actual)
- First posted
- 9 Nov 2023 (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.
Using breast stimulating techniques (skin-to-skin contact, relaxation exercises, breast massage, nipple stimulation, hot application, etc.) stimulates the secretion of milk and increases its amount. This study aimed to determine the effect of care based on the lactation management model offered to mothers whose babies are in the neonatal intensive care unit, on the amount of breast milk and duration of breastfeeding.
Detailed description
Support of prolactin and oxytocin hormones is needed for adequate production and secretion of breast milk. Many factors affect the levels of oxytocin and prolactin in the blood, such as the health status of the mother and the baby after birth, their separation for a while, nutrition, light, stress, fear, and lack of social support. Using breast stimulating techniques (skin-to-skin contact, relaxation exercises, breast massage, nipple stimulation, hot application, etc.) stimulates the secretion of milk and increases its amount. This study aimed to determine the effect of care based on the lactation management model offered to mothers whose babies are in the neonatal intensive care unit, on the amount of breast milk and duration of breastfeeding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- PROSPECTIVE RANDOMIZED CONTROLLED STUDY
| Arm | Type | Receives |
|---|---|---|
| Lactation Management Model-Experimental | Experimental | Other: Lactation Management ModelThe women in the experimental group were told about the care technique in accordance with the Lactation Management Model and were asked to apply it regularly for 3 days.The content of the Lactation Management Model includes skin-to-skin contact, hot application to the breast, relaxation and breast massage, and process monitoring.In this regard, the mother should apply skin-to-skin contact to her baby 12 times a day, 8 times on the 2nd day, 4 times on the 3rd day, hot application to the breast (5 minutes), relaxation technique (3 minutes) and breast massage (5 minutes manual milking, 2 minutes . nipple stimulation, stroking for 3 minutes). |
| Non-application group- Control | No intervention | –No treatment was performed on women in the control group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Between the ages of 18-35,
- The baby is still in intensive care,
- Gave birth at 34 weeks of gestation and above,
- The baby was taken to intensive care within the first 3 days after birth,
- The baby will stay in the neonatal intensive care unit for at least 3 more days,
Key exclusion criteria (10 listed)
- Not between the ages of 18-35,
- The baby is discharged from intensive care,
- Those whose gestational age is less than 34 weeks,
- The baby is taken to intensive care after the first 3 days after birth,
- The baby is in the neonatal intensive care unit for at least 3 days,
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 |
|---|---|---|
| Lactation Management ModelThe mother provides skin-to-skin contact to her baby 12 times a day, 8 times on the 2nd day, 4 times on the 3rd day, hot application to the breast (5 minutes), relaxation technique (3 minutes) and breast massage (5 minutes by hand milking, 2 minutes by breast massage). Head stimulation, stroking for 3 minutes) were asked. | Other | Lactation Management Model-Experimental |
Primary outcome
Scoring system for the amount of breast milk the baby receives
Time frame: Change from before implementation and 4th week of practice
The form developed to evaluate the amount of breast milk the baby receives consists of 5 sections: urine amount, breast condition, stool amount, weight and satisfaction. Each section is grouped into 3 groups in terms of its features and is evaluated over 0, 1, 2 points. In the evaluation, 10 points mean that breast milk is received in the best way, and 7 points and below mean that breast milk is inadequate.
1 secondary outcome
Breast Milk and Breastfeeding Monitoring Form
Time frame: Change from before implementation and 4th week of practice
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 9 May 2025.
- 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.
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 Lactation Management Model in people with Amount of Breast Milk, 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 10 inclusion and 10 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 9 May 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?
Scoring system for the amount of breast milk the baby receives (time frame: Change from before implementation and 4th week of practice). 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 9 May 2025.