The Effect of Breastfeeding Support System

The Effect of Breastfeeding Support System in Newborns on Developmental Findings and Discharge Time

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.

Study Overview

• Status: Completed
• Conditions: Breastfeeding
• Intervention / Treatment: Other: breastfeeding support system

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 Type: Interventional
• Enrollment (Actual): 71
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ağrı, Turkey, 04100
    • Agri Ibrahim Cecen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

1. Inclusion Criteria: Before age of 28 days
2. Exclusion Criteria: After age of 29 days

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Agri Ibrahim Cecen University
• Investigators: Principal Investigator: Fatma GUL CAN, PhD, Agri Ibrahim Cecen University; Principal Investigator: Eda Gülbetekin, PhD, Igdir University; Principal Investigator: Selahattin KARAGÖZ KARAGÖZ, PhD, Iğdır State Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: September 6, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AICU-GULCAN002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No