- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06035419
The Effect of Breastfeeding Education to Immigrant Mothers in the NICU on Breastfeeding Success
The Effect of Training Given to Immigrant Primiparous Mothers in the Neonatal Intensive Care Unit on Breastfeeding Success
Study Overview
Detailed Description
This study aimed to evaluate the effect of education given to immigrant mothers on breastfeeding success of mothers.
Method: In this randomized-controlled, single-blind study, 80 immigrant mothers (40 intervention groups, 40 control groups) were recruited.
The study included primiparous immigrant mothers whose mother tongue was not Turkish, 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 whose suckling was not impaired.
In the study, 40 participants were included in the experimental group and 40 participants in the control group. At the end of the study, Cohen's d was calculated to determine the effect size and was found to be 1.80.
A simple randomization method was used to randomly assign the mothers included in the study to the experimental and control groups. To avoid bias in the study, a nurse who was not involved in the study made 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 a simple randomization method to prevent selection bias in the study.
Mother-baby information form, Nutrition follow-up form, and LATCH were used to collect the study data.
The mothers to be included in the study were informed by an interpreter before the study and their consent was obtained. It was ensured that the mothers in both groups answered the questions in the data collection forms through a translator. Information about the baby was taken from the patient's file.
A specially prepared training program for immigrant mothers was applied to the mothers in the experimental group. In the control group, no interventions were made except for the routine interventions of the clinic (unstructured training practices given by the individual effort of the nurse).
The first of the parameters used to evaluate breastfeeding success is the mothers' LATCH score averages. LATCH scores of mothers were evaluated by observation. LATCH evaluations of the mothers in the experimental group were made at the first breastfeeding before the training and on the 1st, 2nd, and 3rd days after the training. The LATCH evaluations of the control group were made at the first breastfeeding and on the 1st, 2nd, and 3rd days.
Another parameter examined to evaluate breastfeeding success is the suckling time of babies at each breastfeeding. The suckling time of the babies was measured with a stopwatch at each feeding.
The last of the parameters to evaluate breastfeeding success is the feeding style of infants. Information about the feeding style of infants was obtained from the nurse observation form.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pamukkale
-
Denizli, Pamukkale, Turkey
- Pamukkale University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: education
A specially prepared training program for immigrant mothers was applied to the mothers in the experimental group.
|
breastfeeding education for migrant mothers
Other Names:
|
No Intervention: control
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
LATCH score
Time Frame: 3 days
|
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
Time Frame: 3 days
|
To evaluate the suckling time of babies, sucking time was measured with a stopwatch at each feeding.
|
3 days
|
feeding type of babies
Time Frame: 3 days
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PAU SBF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Breastfeeding
-
Marmara UniversityNot yet recruitingBreastfeeding | Breastfeeding Support
-
University of CopenhagenDanish Committee for Health Education; Nordea-fonden; Det Obelske Familiefond; 21...Active, not recruiting
-
Halic UniversityCompletedBreastfeeding | Breastfeeding, ExclusiveTurkey
-
University of Ontario Institute of TechnologyDurham Region Health DepartmentUnknown
-
University of California, DavisUniversity of California, San Francisco; Public Hospital Roatan, HondurasCompletedBreastfeeding | Breastfeeding, ExclusiveHonduras
-
Ahi Evran University Education and Research HospitalThe Scientific and Technological Research Council of TurkeyCompletedBreastfeeding | Breastfeeding, Exclusive | Kangaroo Mother CareTurkey
-
University of Mississippi Medical CenterActive, not recruitingBreastfeeding | Breastfeeding, ExclusiveUnited States
-
Celal Bayar UniversityManisa Celal Bayar UniversityCompletedBreastfeeding | Breastfeeding, ExclusiveTurkey
-
Benten Technologies, Inc.National Institute on Minority Health and Health Disparities (NIMHD); George... and other collaboratorsEnrolling by invitationBreastfeeding | Exclusive BreastfeedingUnited States
-
The University of Hong KongCompletedBreastfeeding | Breastfeeding, ExclusiveHong Kong
Clinical Trials on education
-
Erzincan UniversityCompletedQuality of Life | Nursing Caries | Breastfeeding | Postpartum | Nursing Model | Levine Conservation Model
-
Oregon Health and Science UniversityEnrolling by invitation
-
Mexican National Institute of Public HealthUniversity of North Carolina, Chapel Hill; Danone ResearchCompleted
-
Mclean HospitalCompleted
-
University of South FloridaNational Cancer Institute (NCI)WithdrawnPediatric CancerUnited States
-
University of Social Sciences and Humanities, WarsawNational Science Centre, PolandRecruiting
-
University of MostarUnknownPain Score | Apgar Score | Mental Health Issue | Delivery Mode | Breastfeeding RateBosnia and Herzegovina
-
Centro de Endocrinologia Experimental y AplicadaNational Council of Scientific and Technical Research, ArgentinaCompletedType 2 DiabetesArgentina
-
US Department of Veterans AffairsThe American Legion Department of WisconsinCompletedCoronary Artery Disease | Hypertension | Diabetes Mellitus | HyperlipidemiaUnited States
-
Teesside UniversityCompleted