The Effect of Breastfeeding Support System

The Effect of Breastfeeding Support System on Breast Milk Quantity and Mother-Infant Bonding in Preterm Infants: a Randomized Controlled Study

This study aimed to examine the impact of a breastfeeding support system on breast milk production and mother-infant bonding in preterm infants. The sample included 70 preterm infants and their mothers, divided into two groups: 35 in the control group and 35 in the experimental group, all of whom met the study criteria.

Study Overview

• Status: Completed
• Conditions: Breastfeeding; Preterm; Breast Milk; Breastfeeding Support System
• Intervention / Treatment: Other: Routine nursing care; Other: breastfeeding support system

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey
    • Sümeyye EKİCİ

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

For the infant:

Gestational age between 30 and 34 weeks Birth weight of 1000 g or more

For the mother:

Age over 18, literate, and able to speak Turkish Willingness to breastfeed and no chronic illness preventing breastfeeding

Exclusion Criteria:

Infants without identification Infants with unstable vital signs Mothers with conditions that prevent breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breastfeeding Support System; The intervention group was given breastfeeding support system care	Other: Routine nursing care; Preterm infants in the control group did not receive any intervention other than the routine feeding protocol applied in the clinic.; Other: breastfeeding support system; The body weight of preterm infants in the experimental group was measured and recorded each morning before their first feeding. Mothers of these infants were asked to complete the Mother-Infant Attachment Scale (MIAS) prior to the procedure. The physician determined the appropriate amount of breast milk the infant should receive during feeding. Before each feeding, the neonatal nurse ensured the sterile preparation of the milk and transferred it to the Breastfeeding Support System. The mothers were then prepared for the procedure, with the neonatal nurse explaining how the breastfeeding support system worked. Once both the mother and baby were ready, the baby was placed at the mother's breast. After feeding, the mothers were asked to complete the MIAS again.
No Intervention: Control group; Routine nursing care was given to the pretrms in this groups without any breastfeeding support system care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mother-Infant Attachment Scale	The Turkish validity and reliability of this scale, originally developed by Taylor et al. in 2005, were established by Aydemir Karakulak and Alparslan in 2016. It can be easily and quickly administered by the mother from the first day after birth. The scale consists of 8 items with a four-point Likert-type format. Scores range from 0 to 24, with higher scores indicating a potential attachment issue between the mother and infant.	up to 6 months

Collaborators and Investigators

• Sponsor: Ataturk University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2024
• Last Update Submitted That Met QC Criteria: October 22, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: Sumeyye

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
• product manufactured in and exported from the U.S.: No