Sudden Infant Death SyndromeNCT07032402
The Effect of the Use of Mobile App
A study testing Education and Counseling in people with Sudden Infant Death Syndrome, run by Amasya University at 1 site in Turkey (Türkiye).
Trial summary
This randomized controlled trial aims to evaluate the effect of using the ABÖS-M mobile application, developed for mothers with newborns, on maternal knowledge, care skills, and self-efficacy levels related to Sudden Infant Death Syndrome (SIDS). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Sudden Infant Death Syndrome
- What is being tested?
- Education and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2025to 25 Jul 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Mothers with a healthy newborn baby,
- Mothers who have not experienced any previous child loss,
- Mothers with at least a primary school education,
- Mothers who own a smartphone with mobile internet access,
- Mothers who speak Turkish, are able to understand written and spoken information, follow instructions, and have no communication barriers,
- Mothers who voluntarily agree to participate in the study.
Who cannot join
- Mothers with postpartum depression,
- Mothers who do not complete the educational program within 15 days,
- Mothers who request withdrawal from the study at any stage.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Use of ABÖS-M App Developed for Mothers With Newborn Babies on Knowledge, Skills and Self-Efficacy Levels: Randomized Controlled Study
This randomized controlled trial aims to evaluate the effect of using the ABÖS-M mobile application, developed for mothers with newborns, on maternal knowledge, care skills, and self-efficacy levels related to Sudden Infant Death Syndrome (SIDS).
Read the detailed description
Informing and raising parental awareness on Sudden Infant Death Syndrome (SIDS) and safe sleeping practices is crucial for promoting public health. This study aims to inform mothers about the risk factors involved in SIDS and encourage them to maintain a safe sleeping environment to safeguard their babies. As part of this study, the investigators intend to create a personalised, gamified mobile application training programme for mothers called the ABÖS-M App. Our main objective is to analyse the impact of ABÖS-M App on the knowledge, skills, and self-efficacy levels of mothers. To date, the investigators have not found any randomised controlled studies in Turkey that aim to prevent SIDS. Our study was designed as a single-centre, follow-up, single-blind, randomised controlled trial. The study was designed to include 25 mothers each in the intervention and control groups. The data was collected through a set of forms including the Information Form for Infants and Parents, the Sudden Infant Death Syndrome Knowledge Level Self-Assessment Form, the Sudden Infant Death Syndrome Care Skills Form, and the General Self-Efficacy Scale. Data analysis will be conducted using the Statistical Package for Social Science (SPSS v.23) software licensed by Akdeniz University. Repeated measures will be employed in the investigation to compare the measurements and scores between the intervention and control groups. Spearman correlation analysis will be utilised to evaluate the degree of relationship between the measurements. A significance level of p<0.05 will be considered. Additionally, the effect size of the study will be computed. Consequently, it is anticipated that the ABÖS-M App will enhance the knowledge, skills and self-efficacy levels of the mothers by the end of this project.
- Conditions
- Sudden Infant Death Syndrome
- Being tested
- Education and Counseling, Standard Care
- Keywords
- Sudden Infant Death Syndrome, Mobile Applications, Neonatal Nursing, Randomized Controlled Trial
- Medical subject headings
- Sudden Infant Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and CounselingBehavioural
Mothers who consent will have the ABÖS-M App installed on their smartphones and will create a personal login. Researchers will provide brief training on how to use the app. The intervention consists of four educational modules designed with individualized and gamified content. Mothers are expected to complete all modules within two weeks. The app monitors their progress and provides automated feedback based on their performance, encouraging mothers to review topics if needed. Weekly WhatsApp reminders will be sent to promote app engagement, and researchers will track login frequency and usage time. Mothers who fail to complete the modules within the specified timeframe will be excluded from the study. Participants will also be asked to fill out a daily care diary throughout the intervention period.
Standard CareOther
After obtaining written and verbal consent, the ABÖS-M App will be installed on their smartphones, and researchers will provide face-to-face instructions on its basic use. Mothers in the control group will receive routine newborn care education provided by clinical nurses, which includes non-standardized safe sleep information typically given before hospital discharge. No structured or individualized training will be provided by the researchers during the study period. For one month, control group participants will have limited access to certain app features, including the "About Us" section, care diary, and assessment tools. Mothers will be asked to complete the care diary daily, and researchers will send regular reminders.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Group I | Experimental | Behavioral and Counseling Receives: Behavioral: Education and Counseling |
| Control: Group II | Other | Standard Care Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge
The Sudden Infant Death Syndrome Knowledge Self-Assessment Form was developed by the researchers based on the safe sleep recommendations of the American Academy of Pediatrics and the relevant literature to assess mothers' knowledge levels and caregiving skills related to the causes, risk factors, and preventive interventions for Sudden Infant Death Syndrome. The form consists of a total of 28 items: 3 items assessing general knowledge about SIDS, 15 items evaluating SIDS risk factors, and 10 items evaluating protective factors. The scores obtainable from the form range from 0 to 27. An increase in the score indicates a higher level of knowledge.
Measured: baseline (first assessment)
Knowledge
The Sudden Infant Death Syndrome Knowledge Self-Assessment Form was developed by the researchers based on the safe sleep recommendations of the American Academy of Pediatrics and the relevant literature to assess mothers' knowledge levels and caregiving skills related to the causes, risk factors, and preventive interventions for Sudden Infant Death Syndrome. The form consists of a total of 28 items: 3 items assessing general knowledge about SIDS, 15 items evaluating SIDS risk factors, and 10 items evaluating protective factors. The scores obtainable from the form range from 0 to 27. An increase in the score indicates a higher level of knowledge.
Measured: 2 weeks after from baseline
Knowledge
The Sudden Infant Death Syndrome Knowledge Self-Assessment Form was developed by the researchers based on the safe sleep recommendations of the American Academy of Pediatrics and the relevant literature to assess mothers' knowledge levels and caregiving skills related to the causes, risk factors, and preventive interventions for Sudden Infant Death Syndrome. The form consists of a total of 28 items: 3 items assessing general knowledge about SIDS, 15 items evaluating SIDS risk factors, and 10 items evaluating protective factors. The scores obtainable from the form range from 0 to 27. An increase in the score indicates a higher level of knowledge.
Measured: at the end of the invervention program (4 weeks after from baseline)
Care Skills
The Sudden Infant Death Syndrome Care Skills Form was developed by the researchers based on the relevant literature to assess mothers' caregiving skills related to Sudden Infant Death Syndrome (SIDS). The form consists of 28 items and is designed as a 5-point Likert scale (Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree). The form consists of 28 items measuring the frequency of performing care skills. Participants rate each item on a scale from 'Always' (5 points) to 'Never' (1 point). Total scores range from 28 to 140. An increase in the score indicates that the individual performs care skills more frequently and regularly. Items with negative wording are reverse-scored.
Measured: baseline (first assessment)
Care Skills
The Sudden Infant Death Syndrome Care Skills Form was developed by the researchers based on the relevant literature to assess mothers' caregiving skills related to Sudden Infant Death Syndrome (SIDS). The form consists of 28 items and is designed as a 5-point Likert scale (Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree). The form consists of 28 items measuring the frequency of performing care skills. Participants rate each item on a scale from 'Always' (5 points) to 'Never' (1 point). Total scores range from 28 to 140. An increase in the score indicates that the individual performs care skills more frequently and regularly. Items with negative wording are reverse-scored.
Measured: 2 weeks after from baseline
Care Skills
The Sudden Infant Death Syndrome Care Skills Form was developed by the researchers based on the relevant literature to assess mothers' caregiving skills related to Sudden Infant Death Syndrome (SIDS). The form consists of 28 items and is designed as a 5-point Likert scale (Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree). The form consists of 28 items measuring the frequency of performing care skills. Participants rate each item on a scale from 'Always' (5 points) to 'Never' (1 point). Total scores range from 28 to 140. An increase in the score indicates that the individual performs care skills more frequently and regularly. Items with negative wording are reverse-scored.
Measured: at the end of the invervention program (4 weeks after from baseline)
Self-Efficacy
The General Self-Efficacy Scale is a five-point Likert-type scale. For each item, participants respond to the question "How well does this describe you?" using five options ranging from "Not at all" to "Very well." Each item is scored between 1 and 5. The scale consists of 17 items and demonstrates a three-factor structure: Initiation (9 items: 2, 4, 5, 6, 7, 10, 11, 12, 17), Perseverance (5 items: 3, 13, 14, 15, 16), and Sustained Effort (3 items: 1, 8, 9). The total score ranges from 17 to 85, with higher scores indicating greater self-efficacy.
Measured: baseline (first assessment)
Self-Efficacy
The General Self-Efficacy Scale is a five-point Likert-type scale. For each item, participants respond to the question "How well does this describe you?" using five options ranging from "Not at all" to "Very well." Each item is scored between 1 and 5. The scale consists of 17 items and demonstrates a three-factor structure: Initiation (9 items: 2, 4, 5, 6, 7, 10, 11, 12, 17), Perseverance (5 items: 3, 13, 14, 15, 16), and Sustained Effort (3 items: 1, 8, 9). The total score ranges from 17 to 85, with higher scores indicating greater self-efficacy.
Measured: 2 weeks after from baseline
Self-Efficacy
The General Self-Efficacy Scale is a five-point Likert-type scale. For each item, participants respond to the question "How well does this describe you?" using five options ranging from "Not at all" to "Very well." Each item is scored between 1 and 5. The scale consists of 17 items and demonstrates a three-factor structure: Initiation (9 items: 2, 4, 5, 6, 7, 10, 11, 12, 17), Perseverance (5 items: 3, 13, 14, 15, 16), and Sustained Effort (3 items: 1, 8, 9). The total score ranges from 17 to 85, with higher scores indicating greater self-efficacy.
Measured: at the end of the invervention program (4 weeks after from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start1 Jan 2025
- Primary completion25 Jul 2025
- Study completion25 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Infant Death SyndromeStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amasya University
- Sponsor type
- University, hospital or other
- Collaborators
- Health Institutes of Turkey
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07032402
- Sponsor's protocol ID
- 04012024
- Status last verified
- Jun 2025
- First submitted
- 14 Jun 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be shared on request
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Use of ABÖS-M App Developed for Mothers With Newborn Babies on Knowledge, Skills and Self-Efficacy Levels: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07032402
- Acronym / sponsor ID
- 04012024
- Conditions
- Sudden Infant Death Syndrome
- Keywords
- Sudden Infant Death Syndrome, Mobile Applications, Neonatal Nursing, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Amasya UniversityUniversity, hospital or other
- Collaborators
- Health Institutes of Turkey
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 25 Jul 2025 (actual)
- Study completion
- 25 Jul 2025 (actual)
- First posted
- 24 Jun 2025 (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.
This randomized controlled trial aims to evaluate the effect of using the ABÖS-M mobile application, developed for mothers with newborns, on maternal knowledge, care skills, and self-efficacy levels related to Sudden Infant Death Syndrome (SIDS).
Detailed description
Informing and raising parental awareness on Sudden Infant Death Syndrome (SIDS) and safe sleeping practices is crucial for promoting public health. This study aims to inform mothers about the risk factors involved in SIDS and encourage them to maintain a safe sleeping environment to safeguard their babies. As part of this study, the investigators intend to create a personalised, gamified mobile application training programme for mothers called the ABÖS-M App. Our main objective is to analyse the impact of ABÖS-M App on the knowledge, skills, and self-efficacy levels of mothers. To date, the investigators have not found any randomised controlled studies in Turkey that aim to prevent SIDS. Our study was designed as a single-centre, follow-up, single-blind, randomised controlled trial. The study was designed to include 25 mothers each in the intervention and control groups. The data was collected through a set of forms including the Information Form for Infants and Parents, the Sudden Infant Death Syndrome Knowledge Level Self-Assessment Form, the Sudden Infant Death Syndrome Care Skills Form, and the General Self-Efficacy Scale. Data analysis will be conducted using the Statistical Package for Social Science (SPSS v.23) software licensed by Akdeniz University. Repeated measures will be employed in the investigation to compare the measurements and scores between the intervention and control groups. Spearman correlation analysis will be utilised to evaluate the degree of relationship between the measurements. A significance level of p<0.05 will be considered. Additionally, the effect size of the study will be computed. Consequently, it is anticipated that the ABÖS-M App will enhance the knowledge, skills and self-efficacy levels of the mothers by the end of this project.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Group I | Experimental | Behavioral: Education and CounselingBehavioral and Counseling |
| Control: Group II | Other | Other: Standard CareStandard Care |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Mothers with a healthy newborn baby,
- Mothers who have not experienced any previous child loss,
- Mothers with at least a primary school education,
- Mothers who own a smartphone with mobile internet access,
- Mothers who speak Turkish, are able to understand written and spoken information, follow instructions, and have no communication barriers,
Key exclusion criteria (3 listed)
- Mothers with postpartum depression,
- Mothers who do not complete the educational program within 15 days,
- Mothers who request withdrawal from the study at any stage.
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 |
|---|---|---|
| Education and CounselingMothers who consent will have the ABÖS-M App installed on their smartphones and will create a personal login. Researchers will provide brief training on how to use the app. The intervention consists of four educational modules designed with individualized and gamified content. Mothers are expected to complete all modules within two weeks. The app monitors their progress and provides automated feedback based on their performance, encouraging mothers to review topics if needed. Weekly WhatsApp reminders will be sent to promote app engagement, and researchers will track login frequency and usage time. Mothers who fail to complete the modules within the specified timeframe will be excluded from the study. Participants will also be asked to fill out a daily care diary throughout the intervention period. | Behavioural | Experimental: Group I |
| Standard CareAfter obtaining written and verbal consent, the ABÖS-M App will be installed on their smartphones, and researchers will provide face-to-face instructions on its basic use. Mothers in the control group will receive routine newborn care education provided by clinical nurses, which includes non-standardized safe sleep information typically given before hospital discharge. No structured or individualized training will be provided by the researchers during the study period. For one month, control group participants will have limited access to certain app features, including the "About Us" section, care diary, and assessment tools. Mothers will be asked to complete the care diary daily, and researchers will send regular reminders. | Other | Control: Group II |
Primary outcome
Knowledge
Time frame: baseline (first assessment)
The Sudden Infant Death Syndrome Knowledge Self-Assessment Form was developed by the researchers based on the safe sleep recommendations of the American Academy of Pediatrics and the relevant literature to assess mothers' knowledge levels and caregiving skills related to the causes, risk factors, and preventive interventions for Sudden Infant Death Syndrome. The form consists of a total of 28 items: 3 items assessing general knowledge about SIDS, 15 items evaluating SIDS risk factors, and 10 items evaluating protective factors. The scores obtainable from the form range from 0 to 27. An increase in the score indicates a higher level of knowledge.
Knowledge
Time frame: 2 weeks after from baseline
The Sudden Infant Death Syndrome Knowledge Self-Assessment Form was developed by the researchers based on the safe sleep recommendations of the American Academy of Pediatrics and the relevant literature to assess mothers' knowledge levels and caregiving skills related to the causes, risk factors, and preventive interventions for Sudden Infant Death Syndrome. The form consists of a total of 28 items: 3 items assessing general knowledge about SIDS, 15 items evaluating SIDS risk factors, and 10 items evaluating protective factors. The scores obtainable from the form range from 0 to 27. An increase in the score indicates a higher level of knowledge.
Knowledge
Time frame: at the end of the invervention program (4 weeks after from baseline)
The Sudden Infant Death Syndrome Knowledge Self-Assessment Form was developed by the researchers based on the safe sleep recommendations of the American Academy of Pediatrics and the relevant literature to assess mothers' knowledge levels and caregiving skills related to the causes, risk factors, and preventive interventions for Sudden Infant Death Syndrome. The form consists of a total of 28 items: 3 items assessing general knowledge about SIDS, 15 items evaluating SIDS risk factors, and 10 items evaluating protective factors. The scores obtainable from the form range from 0 to 27. An increase in the score indicates a higher level of knowledge.
Care Skills
Time frame: baseline (first assessment)
The Sudden Infant Death Syndrome Care Skills Form was developed by the researchers based on the relevant literature to assess mothers' caregiving skills related to Sudden Infant Death Syndrome (SIDS). The form consists of 28 items and is designed as a 5-point Likert scale (Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree). The form consists of 28 items measuring the frequency of performing care skills. Participants rate each item on a scale from 'Always' (5 points) to 'Never' (1 point). Total scores range from 28 to 140. An increase in the score indicates that the individual performs care skills more frequently and regularly. Items with negative wording are reverse-scored.
Care Skills
Time frame: 2 weeks after from baseline
The Sudden Infant Death Syndrome Care Skills Form was developed by the researchers based on the relevant literature to assess mothers' caregiving skills related to Sudden Infant Death Syndrome (SIDS). The form consists of 28 items and is designed as a 5-point Likert scale (Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree). The form consists of 28 items measuring the frequency of performing care skills. Participants rate each item on a scale from 'Always' (5 points) to 'Never' (1 point). Total scores range from 28 to 140. An increase in the score indicates that the individual performs care skills more frequently and regularly. Items with negative wording are reverse-scored.
Care Skills
Time frame: at the end of the invervention program (4 weeks after from baseline)
The Sudden Infant Death Syndrome Care Skills Form was developed by the researchers based on the relevant literature to assess mothers' caregiving skills related to Sudden Infant Death Syndrome (SIDS). The form consists of 28 items and is designed as a 5-point Likert scale (Strongly Disagree, Disagree, Neutral, Agree, Strongly Agree). The form consists of 28 items measuring the frequency of performing care skills. Participants rate each item on a scale from 'Always' (5 points) to 'Never' (1 point). Total scores range from 28 to 140. An increase in the score indicates that the individual performs care skills more frequently and regularly. Items with negative wording are reverse-scored.
Self-Efficacy
Time frame: baseline (first assessment)
The General Self-Efficacy Scale is a five-point Likert-type scale. For each item, participants respond to the question "How well does this describe you?" using five options ranging from "Not at all" to "Very well." Each item is scored between 1 and 5. The scale consists of 17 items and demonstrates a three-factor structure: Initiation (9 items: 2, 4, 5, 6, 7, 10, 11, 12, 17), Perseverance (5 items: 3, 13, 14, 15, 16), and Sustained Effort (3 items: 1, 8, 9). The total score ranges from 17 to 85, with higher scores indicating greater self-efficacy.
Self-Efficacy
Time frame: 2 weeks after from baseline
The General Self-Efficacy Scale is a five-point Likert-type scale. For each item, participants respond to the question "How well does this describe you?" using five options ranging from "Not at all" to "Very well." Each item is scored between 1 and 5. The scale consists of 17 items and demonstrates a three-factor structure: Initiation (9 items: 2, 4, 5, 6, 7, 10, 11, 12, 17), Perseverance (5 items: 3, 13, 14, 15, 16), and Sustained Effort (3 items: 1, 8, 9). The total score ranges from 17 to 85, with higher scores indicating greater self-efficacy.
Self-Efficacy
Time frame: at the end of the invervention program (4 weeks after from baseline)
The General Self-Efficacy Scale is a five-point Likert-type scale. For each item, participants respond to the question "How well does this describe you?" using five options ranging from "Not at all" to "Very well." Each item is scored between 1 and 5. The scale consists of 17 items and demonstrates a three-factor structure: Initiation (9 items: 2, 4, 5, 6, 7, 10, 11, 12, 17), Perseverance (5 items: 3, 13, 14, 15, 16), and Sustained Effort (3 items: 1, 8, 9). The total score ranges from 17 to 85, with higher scores indicating greater self-efficacy.
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 31 Jul 2025.
- Individual participant dataSharing planned: Undecided. Data will be shared on request
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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 and Counseling in people with Sudden Infant Death Syndrome, run by Amasya 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 6 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 31 Jul 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?
Knowledge (time frame: baseline (first assessment)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2025.