NCT06003959

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 9, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
Last Updated

October 24, 2024

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

August 9, 2023

Last Update Submit

October 22, 2024

Conditions

Outcome Measures

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.

    up to 6 months

Study Arms (2)

Breastfeeding Support System

EXPERIMENTAL

The intervention group was given breastfeeding support system care

Other: Routine nursing careOther: breastfeeding support system

Control group

NO INTERVENTION

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

Interventions

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

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.

Breastfeeding Support System

Eligibility Criteria

Age30 Months - 34 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sümeyye EKİCİ

Erzurum, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Premature BirthBreast Feeding

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesFeeding BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

August 9, 2023

First Posted

August 22, 2023

Study Start

January 1, 2022

Primary Completion

June 30, 2022

Study Completion

June 30, 2023

Last Updated

October 24, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations