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Completed

NCT Number: NCT06125548

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mersin University

Yenişehir, Mersin, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Mersin University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Nov 9, 2023
Registry last updated
May 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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