Clinical trial NCT06028581: The Effect of Breastfeeding Support System
Official title: The Effect of Breastfeeding Support System in Newborns on Developmental Findings and Discharge Time
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Lead sponsor: Agri Ibrahim Cecen University
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 71
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

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.

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

Primary outcomes:
measure: LATCH Breastfeeding Diagnostic Measurement Tool
timeFrame: After each breastfeeding an average of 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ağrı
country: Turkey
facility: Agri Ibrahim Cecen University
Study officials:
affiliation: Agri Ibrahim Cecen University
name: Fatma GUL CAN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Igdir University
name: Eda GÜLBETEKİN, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iğdır State Hospital
name: Selahattin KARAGÖZ KARAGÖZ, PhD
role: PRINCIPAL_INVESTIGATOR
References: