The Effect of Breastfeeding Support System
1 other identifier
interventional
71
1 country
1
Brief Summary
It is aimed to determine the effect of breastfeeding support system applied in newborns on developmental findings and discharge time.The research was planned as an experimental study with experimental and control groups. The population of the study consisted of babies who received care and treatment in Iğdır State Hospital Neonatal Intensive Care Clinic between February and June 2023. The sample of the study was calculated using the G\*Power computer program. In the calculation made, it was found that a total of 70 children, 35 of each for the control and experimental groups, should be included. In this study, the experimental group consisted of 36 children and the control group consisted of 35 children. Children selected by simple random sampling method were divided into groups by randomization and which group would be the experimental group and which group would be the control group were determined by randomization. Masking was done during data collection and data analysis. The data is in the analysis stage.
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 Feb 2023
Shorter than P25 for not_applicable
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
February 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2023
CompletedFirst Submitted
Initial submission to the registry
July 24, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2023
CompletedFirst Posted
Study publicly available on registry
September 8, 2023
CompletedSeptember 8, 2023
September 1, 2023
5 months
July 24, 2023
September 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
LATCH Breastfeeding Diagnostic Measurement Tool
LATCH Breastfeeding Diagnostic Measurement The tool was developed by Jensen and Wallace in 1993 in Oregon. LATCH is a diagnostic tool created by analogy with the APGAR scoring system in terms of scoring method. Each item is evaluated between 0-2 points. The lowest 0 points and the highest 10 points are obtained from the scale. The Cronbach alpha coefficient of the LATCH Breastfeeding Diagnostic Measurement Tool was reported as 0.94 by Demirhan, 0.96 by Koyun, and 0.95 by Yenal and Okumuş.
After each breastfeeding an average of 4 days
Study Arms (2)
Experimental Group
EXPERIMENTALBreastfeeding support system will be applied to newborn babies in addition to breast milk.
Control Group
NO INTERVENTIONNewborn babies will receive breast milk.
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Agri Ibrahim Cecen University
Ağrı, 04100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Fatma GUL CAN, PhD
Agri Ibrahim Cecen University
- PRINCIPAL INVESTIGATOR
Eda GÜLBETEKİN, PhD
Igdir University
- PRINCIPAL INVESTIGATOR
Selahattin KARAGÖZ KARAGÖZ, PhD
Iğdır State Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Investigator
Study Record Dates
First Submitted
July 24, 2023
First Posted
September 8, 2023
Study Start
February 1, 2023
Primary Completion
June 30, 2023
Study Completion
July 30, 2023
Last Updated
September 8, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share