- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06125548
Care Based on the Lactation Management Model Provided to Mothers With Babies in the Intensive Care Unit
May 6, 2025 updated by: Aslı EKER, Mersin University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mersin
-
Yenisehir, Mersin, Turkey
- Mersin University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 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,
- 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.
Exclusion Criteria:
- 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,
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Lactation Management Model-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).
|
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.
|
|
No Intervention: Non-application group- Control
No treatment was performed on women in the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Change from before implementation and 4th week of practice
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Breast Milk and Breastfeeding Monitoring Form
Time Frame: Change from before implementation and 4th week of practice
|
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.
|
Change from before implementation and 4th week of practice
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2022
Primary Completion (Actual)
September 1, 2022
Study Completion (Actual)
January 10, 2023
Study Registration Dates
First Submitted
November 4, 2023
First Submitted That Met QC Criteria
November 4, 2023
First Posted (Actual)
November 9, 2023
Study Record Updates
Last Update Posted (Actual)
May 9, 2025
Last Update Submitted That Met QC Criteria
May 6, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- Mersin University Midwifery
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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