NCT06035419

Brief Summary

Feeding the infant with breast milk in neonatal intensive care units is essential. However, breastfeeding can be adversely affected in this complex environment, especially for immigrant mothers. In order to ensure the success of breastfeeding in the neonatal intensive care unit, education and support of the mother are required. While doing this, structured and planned education programs should be implemented taking into account the individual characteristics of the mother (culture, age, etc.).This study aimed to evaluate the effect of education given to immigrant mothers on breastfeeding success of mothers. The study was a randomized controlled, single-blind clinical trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2019

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 2, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2020

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

August 31, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.1 years

First QC Date

August 31, 2023

Last Update Submit

September 6, 2023

Conditions

BreastfeedingImmigrant

Keywords

Breast milkNeonatal intensive careImmigrantBreastfeedingEducation

Outcome Measures

Primary Outcomes (3)

  • LATCH score

    LATCH was used to evaluate breastfeeding success. Each item is evaluated between 0-2 points. The total score that can be obtained from the vehicle is 10, and a high score means high breastfeeding success. Evaluation is done through observation.

    3 days

  • sucking time of babies

    To evaluate the suckling time of babies, sucking time was measured with a stopwatch at each feeding.

    3 days

  • feeding type of babies

    Information about the feeding style of infants was obtained from the nurse observation form. The characteristics for the type of nutrition are; breastfeeding only, spoon feeding only, spoon feeding and breastfeeding together.

    3 days

Study Arms (2)

education

EXPERIMENTAL

A specially prepared training program for immigrant mothers was applied to the mothers in the experimental group.

Other: education

control

NO INTERVENTION

No interventions were made to the control group other than the routine interventions of the clinic (unstructured training practices given by the individual effort of the nurse).

Interventions

educationOTHER

breastfeeding education for migrant mothers

Also known as: breastfeeding education
education

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Immigrant mothers whose baby was hospitalized for the first time in the NICU, whose baby was born at 34-40 weeks of gestation, whose baby was fed orally and who did not prevent suckling, whose mother tongue was not Turkish, and who volunteered to participate in the study.

You may not qualify if:

  • Migrant mothers whose babies were hospitalized in the NICU before, whose baby was younger than 34 weeks of gestation, whose baby was not fed orally, who were not primiparous, and who did not volunteer to participate in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pamukkale University

Denizli, Pamukkale, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Feeding BehaviorBehavior

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
In order to avoid bias in the study, a nurse who was not involved in the study performed the LATCH scoring and evaluation of the suckling time and feeding style of the infants, without knowing which group the mothers were in. In addition, mothers to be included in the experimental and control groups were determined by simple randomization method in order to prevent selection bias in the study.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: randomized-controlled and single-blind study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, PhD, RN

Study Record Dates

First Submitted

August 31, 2023

First Posted

September 13, 2023

Study Start

January 2, 2019

Primary Completion

February 7, 2020

Study Completion

February 15, 2020

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

TU(1)