The Effect of Breastfeeding Support System
1 other identifier
interventional
70
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2022
1 active site
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
Study Start
First participant enrolled
January 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedFirst Submitted
Initial submission to the registry
August 9, 2023
CompletedFirst Posted
Study publicly available on registry
August 22, 2023
CompletedOctober 24, 2024
August 1, 2023
6 months
August 9, 2023
October 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Mother-Infant Attachment Scale
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.
up to 6 months
Study Arms (2)
Breastfeeding Support System
EXPERIMENTALThe intervention group was given breastfeeding support system care
Control group
NO INTERVENTIONRoutine nursing care was given to the pretrms in this groups without any breastfeeding support system care
Interventions
Preterm infants in the control group did not receive any intervention other than the routine feeding protocol applied in the clinic.
The body weight of preterm infants in the experimental group was measured and recorded each morning before their first feeding. Mothers of these infants were asked to complete the Mother-Infant Attachment Scale (MIAS) prior to the procedure. The physician determined the appropriate amount of breast milk the infant should receive during feeding. Before each feeding, the neonatal nurse ensured the sterile preparation of the milk and transferred it to the Breastfeeding Support System. The mothers were then prepared for the procedure, with the neonatal nurse explaining how the breastfeeding support system worked. Once both the mother and baby were ready, the baby was placed at the mother's breast. After feeding, the mothers were asked to complete the MIAS again.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Infants without identification Infants with unstable vital signs Mothers with conditions that prevent breastfeeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sümeyye EKİCİ
Erzurum, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research Assistant
Study Record Dates
First Submitted
August 9, 2023
First Posted
August 22, 2023
Study Start
January 1, 2022
Primary Completion
June 30, 2022
Study Completion
June 30, 2023
Last Updated
October 24, 2024
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share