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

Not Applicable

Completed

• Conditions: Amount of Breast Milk
• Interventions: Other: Lactation Management Model

• Registration Number: NCT06125548
• Lead Sponsor: Mersin University

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.

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 Timeline

• Study Start: 2022-01-10
• Primary Completion: 2022-09-01
• Study Completion: 2023-01-10
• Study First Submitted: 2023-11-04
• Study First Submitted QC: 2023-11-04
• Study First Posted: 2023-11-09
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactation Management Model-Experimental	Lactation Management Model	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).

Primary Outcome Measures

Name	Time	Method
Scoring system for the amount of breast milk the baby receives	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.

Secondary Outcome Measures

Name	Time	Method
Breast Milk and Breastfeeding Monitoring Form	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.

Trial Locations

Locations (1)

Mersin University; 🇹🇷 Yenisehir, Mersin, Turkey