BreastfeedingNCT05697302
The Effect of Training and Follow-up Given According to the Health Promotion Model on Relactation Success
A study testing Education, Follow-up and Referral to Lactation and Relactation Polyclinic in people with Breastfeeding, run by Karadeniz Technical University at 1 site in Turkey (Türkiye).
Trial summary
The process of restarting or increasing lactation in a mother who wants to breastfeed her baby again after the termination of breastfeeding or decrease in lactation is called relactation. The research type was planned as a pretest-posttest randomized controlled experimental study. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding
- What is being tested?
- Education, Follow-up and Referral to Lactation and Relactation Polyclinic
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2023to 4 Jan 2025
- 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 18 to 49 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Can read and write Turkish and has no speech impediment,
- Being between the ages of 18-45 and having given birth for the first time,
- Mother and baby not having any health problems that would prevent breastfeeding (medications used in cancer treatment in the mother, some epilepsy medications, psychotherapy medications, migraine medications, Parkinson's medications, some painkillers, radioactive iodine use, active tuberculosis, HIV infection; congenital anomaly, galactosemia disease, phenylketonuria disease, congenital metabolic disease such as urea cycle enzyme defect),
- Not breastfeeding for at least 2 weeks and at most 8 weeks (for mothers who have never breastfed)
- Decreased milk supply that causes babies to be fed with formula for more than 2 weeks (for mothers with low milk supply),
- Having breastfeeding problems that cause decreased milk supply (breast refusal, incorrect breastfeeding techniques, breast abscess… starting work early…). •Separation of the baby or mother due to hospitalization, A mother who is formula feeding her baby changes her mind,
Show all 9Show fewer
- No use of drugs that will affect the amount of milk (galactagogues such as metoclopramide, domperidone),
- The mother can be reached by phone,
- The baby is at least 15 days old and at most 4 months old.
Who cannot join
- Adopted/non-biological babies,
- Any health condition that would prevent breastfeeding or breastfeeding in the mother or baby (medications used in cancer treatment, some epilepsy medications, psychotherapeutic medications, migraine medications, Parkinson's medications, some painkillers, radioactive iodine use, active tuberculosis, HIV infection in the mother; congenital anomaly in the baby, galactosemia disease, phenylketonuria disease, congenital metabolic disease such as urea cycle enzyme defect), Use of medication that would affect milk quantity (galactagogues such as metoclopramide, domperidone)
- Women participating in another study on breastfeeding during the study period will not be included in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Training and Follow-up Given to Mothers with 15 Day-4 Month-old Babies According to the Health Promotion Model on Relactation Success: a Randomized Controlled Study
The process of restarting or increasing lactation in a mother who wants to breastfeed her baby again after the termination of breastfeeding or decrease in lactation is called relactation. The research type was planned as a pretest-posttest randomized controlled experimental study. The research will be carried out between January 2023 and December 2023, with mothers in need of relactation identified in Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital and 7 Family Health Centers in Erzincan city center. The study will be face-to-face, twice a week in the first two weeks of the 1st month, once a week in the other weeks, and once every two weeks in the 2nd month, in a total of 2 months, and will consist of 8 interviews. The number of these meetings may increase depending on the situation of the mother and the baby. Interviews will be held at mothers' homes or at FHCs (whichever they prefer). During the research, based on the SGM, training on the importance of breast milk and breastfeeding, its benefits and relactation techniques, written and visual training materials containing these topics, online messages and online live support by calling the researcher by video or audio when requested, and the breastfeeding process will be supported. The sample will consist of 70 mothers, 35 of whom are in the intervention group and 35 of them are in the control group, who meet the research criteria. In data collection, the World Health Organization (WHO) Simple Routine Evaluation and Breastfeeding Assistance form, Personal Information Form, Breastfeeding Self-Efficacy Scale (EÖYÖ), Breastfeeding Diagnostic Measurement Tool (LATCH) and IMDAT- Scoring System for the Amount of Breastmilk Ingested by the Baby, Breastfeeding Motivation Scale (EMO) and VAS satisfaction scale will be used. Study; The aim of this study was to determine the effect of the education and follow-up given to mothers who need help with relactation on the success of relaxation. The data will be evaluated with the IBM SPSS (Statistical Package for Social Sciences) 22.0 package program. Frequency and percentage will be used in the analysis of the data. In addition, necessary analyzes will be made after testing whether the data obtained comply with the normal distribution. P<0.05 will be used as the 95% confidence interval and significance level in the results.
- Conditions
- Breastfeeding
- Being tested
- Education, Follow-up, Referral to Lactation and Relactation Polyclinic
- Keywords
- Health Promotion Model, Relactation, Lactation
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EducationBehavioural
Interviews will be held twice a week in the first two weeks of the first month, once a week in the following weeks, and once every two weeks in the second month, 8 times in a total of 2 months. The number of 8 interviews planned in the research may increase specifically for the situation of the mother and the baby. Interviews will be held at the mothers' homes or at the Family Health Center. An individualized message will be sent to mothers, two days a week, in accordance with their mobile communication tool, relactation needs. In addition, if the mothers request, they can call the researcher via mobile communication via video or voice and receive live support regarding their questions and questions.
Follow-upBehavioural
Among the data collection forms, LATCH-Breastfeeding Diagnostic Scale and IMDAT-The Baby's Breastmilk Scoring System will be applied at each interview, and the Breastfeeding Self-Efficacy Scale and Breastfeeding Motivation Scale will be applied at the first interview, at the end of the 1st month and at the end of the 2nd month. Mother interviews will be held in their homes or at the Family Health Center (whichever they prefer). At each meeting, an appointment schedule will be made for the next meeting and this information will be shared with the mothers in writing.
Referral to Lactation and Relactation PolyclinicBehavioural
Due to the nature of the research, mothers in the control group will not be given any training, and they will be referred to the Lactation and Relaxation Polyclinic in Erzincan Mengücek Gazi Training and Research Hospital.
| Study group | Role | What they receive |
|---|---|---|
| Relactation | Experimental | Not described Receives: Behavioral: Education; Behavioral: Follow-up |
| Control | Active comparator | Not described Receives: Behavioral: Follow-up; Behavioral: Referral to Lactation and Relactation Polyclinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of mothers' breastfeeding self-efficacy level
The personal information of the mothers who agreed to participate in the study will be recorded, and the breastfeeding self-efficacy level of the mothers will be determined. For this purpose, the Breastfeeding Self-Efficacy Scale will be used. The scale consists of 14 items assessing breastfeeding self-efficacy. The scale is in a 5-point Likert type and the items of the scale are evaluated by grading from 1 = 'I am not sure at all' to 5 = 'I am always sure'. The lowest score that can be obtained from the scale is 14, and the highest score is 70; A higher score means higher breastfeeding self-efficacy.
Measured: 4 months
Relactation success
As a criterion to show that relactation is provided, the daily amount of fluid that the baby should take in the form of 150 ml / kg / day.
The amount of liquid in one meal obtained by dividing the number of feedings will be based on. According to the realization of the relactation,, it will be evaluated as partial (relactation occurs but the continuation of formula feeding with breastfeeding), complete (relactation occurs and the baby is fed only through breastfeeding) or unsuccessful (inability to provide relactation despite all the applications), and the relactation response is considered positive in the following cases. will be: tingling sensation in the breast during breastfeeding; appearance of milk in manual milking; reduction in the daily amount of supplemental milk given to the baby; and infant weight gain. Once a positive response is observed, additional milk supplements will be gradually reduced as breast milk secretion increases.
Measured: 4 months
Determination of mothers' breastfeeding motivation
The personal information of the mothers who accepted to participate in the study will be recorded and the breastfeeding motivation levels of the mothers will be determined. For this purpose, the Breastfeeding Motivation Scale will be used. The scale is in 4-point Likert type and is scored between 1=Strongly Disagree and 4=Strongly Agree for each item. Each item is scored between 1-4. Accordingly, the lowest score that can be obtained from the scale is 23 in primiparous mothers, 24 in multiparous mothers, the highest score is 92 in primiparous mothers and 96 in multiparous mothers. The fact that the values obtained as a result of the study are close to the highest scores indicates that the motivation for breastfeeding is high.
Measured: 4 months
Determination of amount of breast milk the baby receives.
The personal information of the mothers who agreed to participate in the study will be recorded, and the amount of breast milk the baby receives will be determined. For this purpose, the Scoring System for the Amount of Breastmilk Taken by the Baby will be used. The form consists of 5 sections: the weight of the babies, their satisfaction, the frequency and characteristics of urinating and defecation, and the condition of the mother's breasts. With the form, the features of each situation are evaluated as 0, 1, 2 points, and the maximum total score that can be obtained is 10. A score of 8-10 is considered the best breast milk intake, and a score of 0-7 is considered insufficient. This scoring system will be applied in every follow-up, and additional food/food intake management of the baby will be done in line with the information in possible relactation success.
Measured: 4 months
Breastfeeding diagnosis of mothers
The personal information of the mothers who agreed to participate in the study will be recorded, and breastfeeding diagnosis of mothers will be made. For this purpose, the Breastfeeding Diagnostic Scale will be used. This measurement tool consists of five evaluation criteria, which is a combination of the first letters of the English equivalent of these criteria. LATCH's evaluation criteria; L-Latch on breast, A-Audible swallowing, T-Type of nipple, C-Comfort nipple, H-Hold. Each item is evaluated between 0-2 points. The total score that can be taken from the scale is 10.
Measured: 4 months
Secondary outcomes (1)
Levels of satisfaction with the education and follow-up of mothers
"Vissuel Analog Scale (VAS)" will be used to determine the satisfaction of mothers in the intervention group with the nursing care provided to them such as SGM-based education, monitoring, relaxation practices, telephone support, education and monitoring at home, and education and monitoring in FHC. In the scale, mothers will be asked to express their satisfaction level with numbers as "0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10".
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2023
- Study start1 Jan 2023
- Primary completion30 Dec 2023
- Study completion4 Jan 2025
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.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karadeniz Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşe Daştan Yılmaz, Karadeniz Technical University
- Investigators
- Ayşe DAŞTAN YILMAZ, Principal investigator, Erzincan Binali Yildirim UniversitesiKıymet YEŞİLÇİÇEK ÇALIK, Principal investigator, Karadeniz Teknik University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05697302
- Sponsor's protocol ID
- TDK-2023-10842
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2023
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dastan Yilmaz A, Yesilcicek Calik K. Relactation Success: A Randomized Controlled Trial of Health Promotion Model-Based Education and Follow-Up. Breastfeed Med. 2026 Nov;21(11):654-669. doi: 10.1177/15568253261470188. Epub 2026 Jul 21.
PubMed 42478236
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Training and Follow-up Given to Mothers with 15 Day-4 Month-old Babies According to the Health Promotion Model on Relactation Success: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05697302
- Acronym / sponsor ID
- TDK-2023-10842
- Conditions
- Breastfeeding
- Keywords
- Health Promotion Model, Relactation, Lactation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Karadeniz Technical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 4 Jan 2025 (actual)
- First posted
- 25 Jan 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.
The process of restarting or increasing lactation in a mother who wants to breastfeed her baby again after the termination of breastfeeding or decrease in lactation is called relactation. The research type was planned as a pretest-posttest randomized controlled experimental study. The research will be carried out between January 2023 and December 2023, with mothers in need of relactation identified in Erzincan Binali Yıldırım University Mengücek Gazi Training and Research Hospital and 7 Family Health Centers in Erzincan city center. The study will be face-to-face, twice a week in the first two weeks of the 1st month, once a week in the other weeks, and once every two weeks in the 2nd month, in a total of 2 months, and will consist of 8 interviews. The number of these meetings may increase depending on the situation of the mother and the baby. Interviews will be held at mothers' homes or at FHCs (whichever they prefer). During the research, based on the SGM, training on the importance of breast milk and breastfeeding, its benefits and relactation techniques, written and visual training materials containing these topics, online messages and online live support by calling the researcher by video or audio when requested, and the breastfeeding process will be supported. The sample will consist of 70 mothers, 35 of whom are in the intervention group and 35 of them are in the control group, who meet the research criteria. In data collection, the World Health Organization (WHO) Simple Routine Evaluation and Breastfeeding Assistance form, Personal Information Form, Breastfeeding Self-Efficacy Scale (EÖYÖ), Breastfeeding Diagnostic Measurement Tool (LATCH) and IMDAT- Scoring System for the Amount of Breastmilk Ingested by the Baby, Breastfeeding Motivation Scale (EMO) and VAS satisfaction scale will be used. Study; The aim of this study was to determine the effect of the education and follow-up given to mothers who need help with relactation on the success of relaxation. The data will be evaluated with the IBM SPSS (Statistical Package for Social Sciences) 22.0 package program. Frequency and percentage will be used in the analysis of the data. In addition, necessary analyzes will be made after testing whether the data obtained comply with the normal distribution. P<0.05 will be used as the 95% confidence interval and significance level in the results.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Relactation | Experimental | Behavioral: Education, Behavioral: Follow-up |
| Control | Active comparator | Behavioral: Follow-up, Behavioral: Referral to Lactation and Relactation Polyclinic |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Can read and write Turkish and has no speech impediment,
- Being between the ages of 18-45 and having given birth for the first time,
- Mother and baby not having any health problems that would prevent breastfeeding (medications used in cancer treatment in the mother, some epilepsy medications, psychotherapy medications, migraine medications, Parkinson's medications, some painkillers, radioactive iodine use, active tuberculosis, HIV infection; congenital anomaly, galactosemia disease, phenylketonuria disease, congenital metabolic disease such as urea cycle enzyme defect),
- Not breastfeeding for at least 2 weeks and at most 8 weeks (for mothers who have never breastfed)
- Decreased milk supply that causes babies to be fed with formula for more than 2 weeks (for mothers with low milk supply),
Key exclusion criteria (3 listed)
- Adopted/non-biological babies,
- Any health condition that would prevent breastfeeding or breastfeeding in the mother or baby (medications used in cancer treatment, some epilepsy medications, psychotherapeutic medications, migraine medications, Parkinson's medications, some painkillers, radioactive iodine use, active tuberculosis, HIV infection in the mother; congenital anomaly in the baby, galactosemia disease, phenylketonuria disease, congenital metabolic disease such as urea cycle enzyme defect), Use of medication that would affect milk quantity (galactagogues such as metoclopramide, domperidone)
- Women participating in another study on breastfeeding during the study period will not be included 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 |
|---|---|---|
| EducationInterviews will be held twice a week in the first two weeks of the first month, once a week in the following weeks, and once every two weeks in the second month, 8 times in a total of 2 months. The number of 8 interviews planned in the research may increase specifically for the situation of the mother and the baby. Interviews will be held at the mothers' homes or at the Family Health Center. An individualized message will be sent to mothers, two days a week, in accordance with their mobile communication tool, relactation needs. In addition, if the mothers request, they can call the researcher via mobile communication via video or voice and receive live support regarding their questions and questions. | Behavioural | Relactation |
| Follow-upAmong the data collection forms, LATCH-Breastfeeding Diagnostic Scale and IMDAT-The Baby's Breastmilk Scoring System will be applied at each interview, and the Breastfeeding Self-Efficacy Scale and Breastfeeding Motivation Scale will be applied at the first interview, at the end of the 1st month and at the end of the 2nd month. Mother interviews will be held in their homes or at the Family Health Center (whichever they prefer). At each meeting, an appointment schedule will be made for the next meeting and this information will be shared with the mothers in writing. | Behavioural | Control, Relactation |
| Referral to Lactation and Relactation PolyclinicDue to the nature of the research, mothers in the control group will not be given any training, and they will be referred to the Lactation and Relaxation Polyclinic in Erzincan Mengücek Gazi Training and Research Hospital. | Behavioural | Control |
Primary outcome
Determination of mothers' breastfeeding self-efficacy level
Time frame: 4 months
The personal information of the mothers who agreed to participate in the study will be recorded, and the breastfeeding self-efficacy level of the mothers will be determined. For this purpose, the Breastfeeding Self-Efficacy Scale will be used. The scale consists of 14 items assessing breastfeeding self-efficacy. The scale is in a 5-point Likert type and the items of the scale are evaluated by grading from 1 = 'I am not sure at all' to 5 = 'I am always sure'. The lowest score that can be obtained from the scale is 14, and the highest score is 70; A higher score means higher breastfeeding self-efficacy.
Relactation success
Time frame: 4 months
As a criterion to show that relactation is provided, the daily amount of fluid that the baby should take in the form of 150 ml / kg / day. The amount of liquid in one meal obtained by dividing the number of feedings will be based on. According to the realization of the relactation,, it will be evaluated as partial (relactation occurs but the continuation of formula feeding with breastfeeding), complete (relactation occurs and the baby is fed only through breastfeeding) or unsuccessful (inability to provide relactation despite all the applications), and the relactation response is considered positive in the following cases. will be: tingling sensation in the breast during breastfeeding; appearance of milk in manual milking; reduction in the daily amount of supplemental milk given to the baby; and infant weight gain. Once a positive response is observed, additional milk supplements will be gradually reduced as breast milk secretion increases.
Determination of mothers' breastfeeding motivation
Time frame: 4 months
The personal information of the mothers who accepted to participate in the study will be recorded and the breastfeeding motivation levels of the mothers will be determined. For this purpose, the Breastfeeding Motivation Scale will be used. The scale is in 4-point Likert type and is scored between 1=Strongly Disagree and 4=Strongly Agree for each item. Each item is scored between 1-4. Accordingly, the lowest score that can be obtained from the scale is 23 in primiparous mothers, 24 in multiparous mothers, the highest score is 92 in primiparous mothers and 96 in multiparous mothers. The fact that the values obtained as a result of the study are close to the highest scores indicates that the motivation for breastfeeding is high.
Determination of amount of breast milk the baby receives.
Time frame: 4 months
The personal information of the mothers who agreed to participate in the study will be recorded, and the amount of breast milk the baby receives will be determined. For this purpose, the Scoring System for the Amount of Breastmilk Taken by the Baby will be used. The form consists of 5 sections: the weight of the babies, their satisfaction, the frequency and characteristics of urinating and defecation, and the condition of the mother's breasts. With the form, the features of each situation are evaluated as 0, 1, 2 points, and the maximum total score that can be obtained is 10. A score of 8-10 is considered the best breast milk intake, and a score of 0-7 is considered insufficient. This scoring system will be applied in every follow-up, and additional food/food intake management of the baby will be done in line with the information in possible relactation success.
Breastfeeding diagnosis of mothers
Time frame: 4 months
The personal information of the mothers who agreed to participate in the study will be recorded, and breastfeeding diagnosis of mothers will be made. For this purpose, the Breastfeeding Diagnostic Scale will be used. This measurement tool consists of five evaluation criteria, which is a combination of the first letters of the English equivalent of these criteria. LATCH's evaluation criteria; L-Latch on breast, A-Audible swallowing, T-Type of nipple, C-Comfort nipple, H-Hold. Each item is evaluated between 0-2 points. The total score that can be taken from the scale is 10.
1 secondary outcome
Levels of satisfaction with the education and follow-up of mothers
Time frame: 4 months
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 28 Jan 2025.
- Derived from this study: PubMed 42478236Dastan Yilmaz A, Yesilcicek Calik K. Relactation Success: A Randomized Controlled Trial of Health Promotion Model-Based Education and Follow-Up. Breastfeed Med. 2026 Nov;21(11):654-669. doi: 10.1177/15568253261470188. Epub 2026 Jul 21.
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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.
Ayşe DAŞTAN YILMAZ principal investigator
Erzincan Binali Yildirim Universitesi
Kıymet YEŞİLÇİÇEK ÇALIK principal investigator
Karadeniz Teknik University
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, Follow-up and Referral to Lactation and Relactation Polyclinic in people with Breastfeeding, run by Karadeniz Technical 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 9 inclusion and 3 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 28 Jan 2025. 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?
Determination of mothers' breastfeeding self-efficacy level (time frame: 4 months). The study lists 5 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 NCT05697302, 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 28 Jan 2025.