The Effect of Breastfeeding Support System

NCT ID: NCT06028581

Last Updated: 2023-09-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-07-30

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.

Conditions

Breastfeeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Experimental Group

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

Group Type: EXPERIMENTAL

breastfeeding support system

Intervention Type: OTHER

Using the breastfeeding support system

Control Group

Newborn babies will receive breast milk.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

breastfeeding support system

Using the breastfeeding support system

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Inclusion Criteria: Before age of 28 days 2.

Exclusion Criteria

Exclusion Criteria: After age of 29 days

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 28 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Agri Ibrahim Cecen University

OTHER

Sponsor Role: lead

Responsible Party

Fatma GUL CAN

Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatma GUL CAN, PhD

Role: PRINCIPAL_INVESTIGATOR

Agri Ibrahim Cecen University

Eda GÜLBETEKİN, PhD

Role: PRINCIPAL_INVESTIGATOR

Igdir University

Selahattin KARAGÖZ KARAGÖZ, PhD

Role: PRINCIPAL_INVESTIGATOR

Iğdır State Hospital

Locations

Agri Ibrahim Cecen University

Ağrı, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

AICU-GULCAN002

Identifier Type: -

Identifier Source: org_study_id