CClinicalTrials.gg
CompletedNCT06003959Updated Oct 24, 2024

The Effect of Breastfeeding Support System

An interventional study of Routine nursing care and breastfeeding support system in Preterm, Breastfeeding and Breast Milk, sponsored by Ataturk University. Completed at 1 site in Turkey. Open to participants aged 30 Months to 34 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-24.

Sponsored by Ataturk University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Jan 2022, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
30 Months to 34 Months
Sex
All
01

Study 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.

02

Conditions studied

  • Preterm
  • Breastfeeding
  • Breast Milk
  • Breastfeeding Support System

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03

In context

Premature Birth

2,554 studies on the registry are indexed under Premature Birth; 498 are open to participants now.

This study's enrollment of 70 is below the median of 84 across 1,689 interventional studies indexed under Premature Birth.

Browse Premature Birth studies →

Lead sponsor

Ataturk University is the lead sponsor of 442 studies on the registry; 121 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Months to 34 Months
Sexes eligible
All
Accepts 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

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (actual)

Study arms

  • Experimental
    Breastfeeding Support System

    The intervention group was given breastfeeding support system care

    Other: Routine nursing care · Other: breastfeeding support system

  • No intervention
    Control group

    Routine nursing care was given to the pretrms in this groups without any breastfeeding support system care

Interventions

  • OtherRoutine nursing care

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

  • Otherbreastfeeding 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 6 months

07

Study locations

1 site
  • Sümeyye EKİCİ
    Erzurum, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06003959
Lead sponsor
Ataturk University
Responsible party
Sümeyye EKİCİ (Research Assistant, Ataturk University) — Principal investigator
First posted
Aug 22, 2023
Start date
Jan 1, 2022
Primary completion
Jun 30, 2022
Completion
Jun 30, 2023
Last update
Oct 24, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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