The Effect of Breastfeeding Support System

Sponsor
Agri Ibrahim Cecen University (Other)
Overall Status
Completed
CT.gov ID
NCT06028581
Collaborator
(none)
71
1
2
5.9
12.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: breastfeeding support system
N/A

Detailed Description

Breast milk is a natural food with high bioavailability, easy to digest, which reduces the morbidity and mortality of the newborn, contains all the fluid, energy and nutrients necessary for physical, spiritual and mental development.Breastfeeding has a biological and emotional impact on mother and baby, has many immunological, psychological, social and economic benefits for both mother and baby, and is the best method for maternal health and healthy growth and development of infants.The bond between mother and baby after birth In the sensitive period in which successful breastfeeding will be established by establishing a new hospital, some babies need to be hospitalized in the neonatal intensive care unit (NICU) for various reasons. During hospitalization, mothers cannot be with their babies during all feedings and often have to empty their breasts with a pump. The pump does not have the same physiological effect as breastfeeding on the milk injection response.

Due to some problems arising from the breast or the baby, the baby may have problems in grasping and holding the breast. In such cases, a breastfeeding support system can be used.

The breastfeeding support system is based on the logic of stimulating the formation of prolactin by the baby's sucking of the milk, assuming that it comes from the breast, with the help of a plastic tube (usually a nasogastric tube) that is fixed to the breast on one end and the other end inside the bottle/container containing breast milk or formula.With this method, it is aimed to increase milk production and restart breastfeeding through active sucking of the newborn and stimulation of the breasts.

Study Design

Study Type:
Interventional
Actual Enrollment :
71 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Single (Participant)
Primary Purpose:
Supportive Care
Official Title:
The Effect of Breastfeeding Support System in Newborns on Developmental Findings and Discharge Time
Actual Study Start Date :
Feb 1, 2023
Actual Primary Completion Date :
Jun 30, 2023
Actual Study Completion Date :
Jul 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Group

Breastfeeding support system will be applied to newborn babies in addition to breast milk.

Other: breastfeeding support system
Using the breastfeeding support system

No Intervention: Control Group

Newborn babies will receive breast milk.

Outcome Measures

Primary Outcome Measures

  1. LATCH Breastfeeding Diagnostic Measurement Tool [After each breastfeeding an average of 4 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
1 Day to 28 Days
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
  1. Inclusion Criteria: Before age of 28 days

  2. Exclusion Criteria: After age of 29 days

Contacts and Locations

Locations

Site City State Country Postal Code
1 Agri Ibrahim Cecen University Ağrı Turkey 04100

Sponsors and Collaborators

  • Agri Ibrahim Cecen University

Investigators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fatma GUL CAN, Investigator, Agri Ibrahim Cecen University
ClinicalTrials.gov Identifier:
NCT06028581
Other Study ID Numbers:
  • AICU-GULCAN002
First Posted:
Sep 8, 2023
Last Update Posted:
Sep 8, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 8, 2023