BreastfeedingNCT06035419
The Effect of Breastfeeding Education to Immigrant Mothers in the NICU on Breastfeeding Success
A study testing education in people with Breastfeeding and Immigrant, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breastfeeding, Immigrant
- What is being tested?
- education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2019to 15 Feb 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Training Given to Immigrant Primiparous Mothers in the Neonatal Intensive Care Unit on Breastfeeding Success
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.
Read the 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.
- Conditions
- Breastfeeding, Immigrant
- Being tested
- education
- Keywords
- Breast milk, Neonatal intensive care, Immigrant, Breastfeeding, Education
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educationOther
Also called breastfeeding education
breastfeeding education for migrant mothers
| Study group | Role | What they receive |
|---|---|---|
| education | Experimental | A specially prepared training program for immigrant mothers was applied to the mothers in the experimental group. Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 days
sucking time of babies
To evaluate the suckling time of babies, sucking time was measured with a stopwatch at each feeding.
Measured: 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.
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start2 Jan 2019
- Primary completion7 Feb 2020
- Study completion15 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BreastfeedingStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized-controlled and single-blind study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sibel Serap Ceylan, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035419
- Sponsor's protocol ID
- PAU SBF
- Status last verified
- Sep 2023
- First submitted
- 31 Aug 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ceylan SS, Guner E, Keskin Z, Ceylan S. The Effect of Breastfeeding Education to Immigrant Mothers in the Neonatal Intensive Care Unit on Breastfeeding Success: A Randomized Control Study. J Transcult Nurs. 2025 May;36(3):232-242. doi: 10.1177/10436596241297983. Epub 2024 Nov 18.
PubMed 39552558
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training Given to Immigrant Primiparous Mothers in the Neonatal Intensive Care Unit on Breastfeeding Success
- ClinicalTrials.gov ID
- NCT06035419
- Acronym / sponsor ID
- PAU SBF
- Conditions
- Breastfeeding, Immigrant
- Keywords
- Breast milk, Neonatal intensive care, Immigrant, Breastfeeding, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 15 Feb 2020 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- randomized-controlled and single-blind study
| Arm | Type | Receives |
|---|---|---|
| education | Experimental | Other: educationA specially prepared training program for immigrant mothers was applied to the mothers in the experimental group. |
| 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). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educationAlso: breastfeeding educationbreastfeeding education for migrant mothers | Other | education |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 39552558Ceylan SS, Guner E, Keskin Z, Ceylan S. The Effect of Breastfeeding Education to Immigrant Mothers in the Neonatal Intensive Care Unit on Breastfeeding Success: A Randomized Control Study. J Transcult Nurs. 2025 May;36(3):232-242. doi: 10.1177/10436596241297983. Epub 2024 Nov 18.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education in people with Breastfeeding and Immigrant, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LATCH score (time frame: 3 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06035419, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.