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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06125548
Enrollment
80
Registered
2023-11-09
Start date
2022-01-10
Completion date
2023-01-10
Last updated
2025-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amount of Breast Milk

Keywords

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

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.

Interventions

OTHERLactation 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.

Sponsors

Mersin University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

All mothers included in the sample were assigned to experimental and control groups using the randomization table.

Intervention model description

PROSPECTIVE RANDOMIZED CONTROLLED STUDY

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Scoring system for the amount of breast milk the baby receivesChange from before implementation and 4th week of practiceThe 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

MeasureTime frameDescription
Breast Milk and Breastfeeding Monitoring FormChange from before implementation and 4th week of practiceIt 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026