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Completed

NCT Number: NCT06003959

The Effect of Breastfeeding Support System

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.

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Key information

Age range

30 month–34 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sümeyye EKİCİ

Erzurum, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Routine Nursing Care

Other

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

breastfeeding support system

Other

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.

Primary outcomes

  1. Mother-Infant Attachment Scale

    Time frame: up to 6 months

    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.

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2023
First posted
Aug 22, 2023
Registry last updated
Oct 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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