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Clinical Trials/NCT06003959
NCT06003959
Completed
Not Applicable

The Effect of Breastfeeding Support System on Breast Milk Quantity and Mother-Infant Bonding in Preterm Infants: a Randomized Controlled Study

Ataturk University1 site in 1 country70 target enrollmentJanuary 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Preterm
Sponsor
Ataturk University
Enrollment
70
Locations
1
Primary Endpoint
Mother-Infant Attachment Scale
Status
Completed
Last Updated
last year

Overview

Brief Summary

This study aimed to examine the impact of a breastfeeding support system on breast milk production and mother-infant bonding in preterm infants. The sample included 70 preterm infants and their mothers, divided into two groups: 35 in the control group and 35 in the experimental group, all of whom met the study criteria.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
June 30, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sümeyye EKİCİ

Research Assistant

Ataturk University

Eligibility Criteria

Inclusion Criteria

  • For the infant:
  • Gestational age between 30 and 34 weeks Birth weight of 1000 g or more
  • For the mother:
  • Age over 18, literate, and able to speak Turkish Willingness to breastfeed and no chronic illness preventing breastfeeding

Exclusion Criteria

  • Infants without identification Infants with unstable vital signs Mothers with conditions that prevent breastfeeding

Outcomes

Primary Outcomes

Mother-Infant Attachment Scale

Time Frame: up to 6 months

The Turkish validity and reliability of this scale, originally developed by Taylor et al. in 2005, were established by Aydemir Karakulak and Alparslan in 2016. It can be easily and quickly administered by the mother from the first day after birth. The scale consists of 8 items with a four-point Likert-type format. Scores range from 0 to 24, with higher scores indicating a potential attachment issue between the mother and infant.

Study Sites (1)

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