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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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).
Other: Lactation Management Model
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mersin University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 10, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 4, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 4, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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