Care Based on the Lactation Management Model Provided to Mothers With Babies in the Intensive Care Unit

NCT06125548 | Completed DMC

• 1 other identifier: Mersin University Midwifery
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Breastfeeding; Lactation Management Model; Breast Milk; Neonatal Intensive Care

Outcome Measures

Primary Outcomes (1)

• 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.

  Change from before implementation and 4th week of practice

Secondary Outcomes (1)

• Breast Milk and Breastfeeding Monitoring Form

  Change from before implementation and 4th week of practice

Study Arms (2)

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).

Other: Lactation Management Model

Non-application group- Control

NO INTERVENTION

No treatment was performed on women in the control group.

Interventions

Lactation Management Model OTHER

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.

Lactation Management Model-Experimental

Eligibility Criteria

• Age: 18 Years - 35 Years
• Gender Eligibility Details: Since it was a study on breastfeeding and breast milk, only women were included in the study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University

Yenişehir, Mersin, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: All mothers included in the sample were assigned to experimental and control groups using the randomization table.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Model Details: PROSPECTIVE RANDOMIZED CONTROLLED STUDY

Study Record Dates

• First Submitted: November 4, 2023
• First Posted: November 9, 2023
• Study Start: January 10, 2022
• Primary Completion: September 1, 2022
• Study Completion: January 10, 2023
• Last Updated: May 9, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)