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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06003959
Enrollment
70
Registered
2023-08-22
Start date
2022-01-01
Completion date
2023-06-30
Last updated
2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm, Breastfeeding, Breast Milk, Breastfeeding Support System

Brief summary

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.

Interventions

Preterm infants in the control group did not receive any intervention other than the routine feeding protocol applied in the clinic.

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.

Sponsors

Ataturk University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
30 Months to 34 Months
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Mother-Infant Attachment Scaleup to 6 monthsThe 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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026