NCT07709663

Brief Summary

Breast milk is of great importance for preterm infants in terms of optimal growth, immune system development, and neurodevelopment. However, mothers who give birth prematurely may face various challenges during the breastfeeding process due to their infants' need for monitoring in the neonatal intensive care unit, mother-infant separation, and the need to pump breast milk. This situation can negatively affect the experience of expressing breast milk and the mother's perception of her competence in caring for her baby. The aim of this randomized controlled trial is to evaluate the effect of web-based breastfeeding counseling on the breast milk expression experience and the competence in caring for a preterm infant among mothers of preterm infants. A total of 56 mothers who gave birth preterm at 30 weeks of gestation or later and whose infants are being monitored in the neonatal intensive care unit will be included in the study. Participants will be randomly assigned to the intervention and control groups. Mothers in the intervention group will have access to a Moodle-based training program that includes video training on breastfeeding counseling and care for premature infants, as well as the opportunity to ask the researcher questions online. Mothers in the control group, on the other hand, will continue to receive the hospital's routine education and care services. The primary outcome measures of the study will be assessed using the Breastfeeding Experience Scale and the Premature Infant Care Competence Assessment Tool. Measurements will be taken at the start of the study, following the training, and at the end of the one-month follow-up period to examine the effect of web-based counseling on mothers' breastfeeding experience and care competence.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 16, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 12, 2026

Last Update Submit

July 17, 2026

Conditions

Keywords

Web-based consultingbreast milk pumpinginfant care

Outcome Measures

Primary Outcomes (2)

  • A Tool for Measuring the Caregiving Competence of Mothers of Premature Infants (CUIDAR-MaPre)

    The scale consists of 32 items across 7 subdimensions. The maximum possible score on the scale is 128; scores of 64 or below indicate low care competence, scores between 65 and 102 indicate moderate care competence, and scores of 103 or higher indicate high care competence. There are no reverse-scored items on the scale. Responses are almost never rated as "1," rarely as "2," frequently as "3," and almost always as "4."

    one month

  • Breast Milk Expression Experience Scale

    The scale consists of 11 items and three subscales. The lowest possible score on the scale is 1, and the highest is 5. When the mean total score on the scale is less than 3, mothers' breast-milk expression experience is considered negative; when it is higher than 3, it is considered positive. The scale consists of the subdimensions of social support, personal experience, and learning experience. Item 7 on the scale is reverse-coded. The scale's Cronbach's alpha value is 0.82.

    one month

Study Arms (2)

response team

EXPERIMENTAL

Participants assigned to the experimental group will receive a web-based breastfeeding counseling and preterm infant care education program delivered through a Moodle-based platform in addition to routine hospital care. The program includes educational videos on breastfeeding, breast milk expression, breast milk storage, kangaroo care, management of common breastfeeding problems, preterm infant care, and post-discharge care. Participants will have continuous access to the educational materials throughout the study and may communicate with the researcher through the platform when needed.

Behavioral: Web-Based Breastfeeding Counseling and Infant Care Program

control group

ACTIVE COMPARATOR

Participants assigned to the control group will receive the routine breastfeeding education and standard postpartum care provided by the hospital. They will not receive the web-based breastfeeding counseling program during the study period.

Other: control group

Interventions

Participants assigned to the intervention group will receive a web-based breastfeeding counseling program delivered through a Moodle-based platform in addition to routine hospital care. The program includes evidence-based educational videos on breastfeeding, breast milk expression techniques, breast milk storage, kangaroo care, management of common breastfeeding problems, preterm infant care, and post-discharge care. Participants may access the educational materials at any time during the study and communicate with the researcher through the platform for counseling and support.

response team

Participants assigned to the control group will receive the standard postpartum care and routine breastfeeding education provided by the hospital. No additional web-based breastfeeding counseling or educational program will be provided during the study period.

control group

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • To be a first-time mother (primipara).
  • To have had a preterm birth at 30 weeks or more of gestation.
  • For the baby to be hospitalized in the neonatal intensive care unit.
  • For the newborn to have no medical condition that prevents breastfeeding.
  • To be able to read and understand Turkish.
  • To be willing to participate in the study.

You may not qualify if:

  • Mothers with a medical condition contraindicating breastfeeding.
  • Infants with a major congenital anomaly or medical condition preventing breast milk feeding.
  • Withdrawal of consent or inability to complete follow-up assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Premature Birth

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Abide Başpınar

    Medipol University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Participants will be randomly assigned to either the intervention group or the control group in a 1:1 ratio. Participants assigned to the intervention group will receive a web-based breastfeeding counseling and premature infant care education program in addition to routine care; participants assigned to the control group will receive only the routine care provided by the hospital. Participants will remain in the group to which they were assigned for the duration of the study, and there will be no switching between groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2026

First Posted

July 16, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 28, 2027

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share