BreastfeedingNCT05503069
Community Interventions to Improve Breastfeeding
A study testing Interventions with social and cultural components in people with Breastfeeding and Breastfeeding, Exclusive, run by University of Mississippi Medical Center at 1 site in United States.
Trial summary
The percentage of women breastfeeding their newborn babies is very low among minority populations such as African American women in Mississippi. There are good results with initiatives supporting the initiation of breastfeeding after delivery. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Breastfeeding, Breastfeeding, Exclusive
- What is being tested?
- Interventions with social and cultural components
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2022to 25 Feb 2026
- 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 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women
- Age: 25 to 35 years of age
- Delivery: Full-term, singleton delivery at UMMC Infants
- Gestational Age: ≥ 37 weeks of gestation
- Sex: Both sexes
Who cannot join
- Women
- Perinatal complication
- Medical indication to withhold breastfeeding practices Infants
- Prematurity
- Medical indication to withhold breastfeeding
- Congenital condition/malformation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Mississippi Medical Center-Nursery Department of Pediatrics
Jackson, Mississippi, 39216
About this study
Official title: Community Interventions to Improve Breastfeeding Rate in African American Mothers
The percentage of women breastfeeding their newborn babies is very low among minority populations such as African American women in Mississippi. There are good results with initiatives supporting the initiation of breastfeeding after delivery. However, the percentages of continuation of breastfeeding up to 3, 6 or 12 months are still very low in Mississippi. Therefore, this project is proposing to focus on community interventions including social and cultural components to promote and support continuation of breastfeeding.
- The social component will include interventions to promote supportive environments in the workplace for lactating mothers, as well as promoting the use of mother's milk to feed infants in daycare centers.
- The cultural component will focus on educating and raising awareness of the benefit of BF to prevent absenteeism at work, to reduce child illnesses, and to promote healthy child development. The cultural component will target the mother with her family and spouse/partner, employers, and daycare managers.
Read the detailed description
The hypothesis of whether community interventions supporting breastfeeding practices will increase the rates of continuing breastfeeding at 6 and 12 months among African American women, will be tested with the following specific aims Aim 1: Will test whether providing breast milk pumping machine to lactating mothers will promote continuation of breastfeeding up to 6 and 12 months.
The intervention associated with this aim will include the provision of breast milk pumping machines free of charge to new mothers in the intervention arm at the time of discharge from the hospital. Mothers in the control group will follow standard of care practices, which do not include provision of pumping machines at discharge from the hospital.
Aim 2: Will test whether providing training to improve dietary literacy for lactating mothers will improve continuation of breastfeeding up to 6 and 12 months.
The intervention associated with this aim will include training session on topic related to dietary practices for lactating mothers.
Aim 3: Will test whether providing educational materials describing the benefits breastfeeding to family members, employers, and day care managers will improve continuing breastfeeding up to 6 and 12 months.
Study Design This project will utilize a cohort case-controlled study design. There will be two arms with equally enrolled participants in each arm (1:1). Participants will be allocated in the control and intervention arm utilizing simple randomization with fixed number (n=60) for each arm distributed in group A (control) and group B (intervention). The participants will randomly select an envelope concealing the group label after signed the consent form. The participants will open the envelope in front of research coordinator and the allocation group will be revealed.
The study will target African American women between 25 and 35 years of age who delivered singleton full term babies at the University of Mississippi Medical Center, without any perinatal complications. Babies of both sexes will be included. The Dyads of mother/infant participants will be randomized in the following groups: A- Control arm with n=60 participants, and B- Intervention arm with n=60 participants.
Women in the intervention arm will receive standard of care, which includes basic training in breastfeeding by lactation educators, and the action items related to the intervention.
The intervention will include the following
- Providing a breast milk pumping machine to the mother,
- Facilitating training session to improve dietary literacy for lactating mothers,
- Distribution of educational material describing the benefits of continuing breastfeeding infants up to 12 months of age to family members, employers, day care managers/caregivers.
The control group will receive standard of care, which include basic training by lactation educators.
- Conditions
- Breastfeeding, Breastfeeding, Exclusive
- Being tested
- Interventions with social and cultural components
- Keywords
- Breastfeeding, African American Mothers
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interventions with social and cultural componentsBehavioural
Intervention Components
- Enrollment: We are expecting an enrollment rate of 20 participants per week, and completing enrollment in 6 weeks (n=120 participants)
- Baseline Data Collection
- Distribution of Educational Materials
- Lactation Training
- Dietary Literacy Training
- Follow Up Data collection: Infant's information on growth and development and Medical History of Infections, GI problems (diarrhea, constipation, colic, vomits, reflux) will be collected at 3, 6 and 12 months.
- Follow UP Surveys: Mothers will complete a short survey at 3, 6, and 12 months exploring their breastfeeding behaviors and challenges.
- Exit survey: Mothers will be asked to complete an exit survey on month 12 post-enrollment to explore their perception on the participation in the study.
| Study group | Role | What they receive |
|---|---|---|
| Group A - Control | No intervention | The control group will receive standard of care, which include basic training by lactation educators. |
| Group B - Intervention | Experimental | Women in the intervention arm will receive standard of care, which includes basic training in breastfeeding by lactation educators, and the action items related to the intervention.
The intervention will include the following
1. Providing a breast milk pumping machine to the mother,
2. Facilitating training session to improve dietary literacy for lactating mothers,
3. Distribution of educational material describing the benefits of continuing breastfeeding infants up to 12 months of age to family members, employers, day care managers/caregivers. Receives: Behavioral: Interventions with social and cultural components |
What is being measured
The primary outcome is the main question the study is designed to answer.
Outcomes in Mothers at 3 months
-Rates of continuation of breastfeeding at 3 months will be collected during the short phone interview.
Measured: At 3 months post enrollment.
Outcomes in Mothers at 6 months
-Rates of continuation of breastfeeding at 6 months will be collected during the short phone interview.
Measured: At 6 months post enrollment.
Outcomes in Mothers at 12 months
-Rates of continuation of breastfeeding at 12 months will be collected during the short phone interview.
Measured: At 12 months post enrollment.
Outcomes in Mothers Perceptions on Support at 12 months
-Perception of mother on community support to promote breastfeeding will be explored with the exit survey.
Measured: At 12 months post enrollment.
Outcomes in Mothers Perceptions on Infant's wellbeing at 12 months
-Perception of mother on infant wellbeing associated with breastfeeding practices will explored with exit survey.
Measured: At 12 months post enrollment.
Outcomes in Infant's development at 3 months
Development and growth using the percentile in growth chart will be collected at 3 months of age.
Measured: At 3 months post natal
Outcomes in Infant's development at 6 months
Development and growth using the percentile in growth chart will be collected at 6 months of age.
Measured: At 6 months post natal
Outcomes in Infant's development at 12 months
Development and growth using the percentile in growth chart will be collected at 12 months of age.
Measured: At 12 months post natal
Outcomes in Infant's health at 3 months
-Incidence of infections and gastrointestinal problems will be collected at 3 months of age.
Measured: At 3 months post natal
Outcomes in Infant's health at 6 months
-Incidence of infections and gastrointestinal problems will be collected at 6 months of age.
Measured: At 6 months post natal
Outcomes in Infant's health at 12 months
-Incidence of infections and gastrointestinal problems will be collected at 12 months of age.
Measured: At 12 months post natal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start23 Sep 2022
- Primary completion31 Dec 2025
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Model description
- This project will utilize a cohort case-controlled study design. There will be two arms with equally enrolled participants in each arm (1:1). Participants will be allocated in the control and intervention arm utilizing simple randomization with fixed number (n=60) for each arm distributed in group A (control) and group B (intervention). The participants will randomly select an envelope concealing the group label after signed the consent form.
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Mississippi Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norma Ojeda, University of Mississippi Medical Center
- Investigators
- Norma B Ojeda, MD, Principal investigator, University of Mississippi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503069
- Sponsor's protocol ID
- Breastfeeding DN00486
- Status last verified
- Apr 2026
- First submitted
- 1 Aug 2022
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is not including a plan to share IPD with other researchers.
Publications
O'Hare C, Kuh D, Hardy R. Association of Early-Life Factors With Life-Course Trajectories of Resting Heart Rate: More Than 6 Decades of Follow-up. JAMA Pediatr. 2018 Apr 2;172(4):e175525. doi: 10.1001/jamapediatrics.2017.5525. Epub 2018 Apr 2.
PubMed 29435577Schwarzenberg SJ, Georgieff MK; COMMITTEE ON NUTRITION. Advocacy for Improving Nutrition in the First 1000 Days to Support Childhood Development and Adult Health. Pediatrics. 2018 Feb;141(2):e20173716. doi: 10.1542/peds.2017-3716. Epub 2018 Jan 22.
PubMed 29358479Rantalainen V, Lahti J, Henriksson M, Kajantie E, Mikkonen M, Eriksson JG, Raikkonen K. Association between breastfeeding and better preserved cognitive ability in an elderly cohort of Finnish men. Psychol Med. 2018 Apr;48(6):939-951. doi: 10.1017/S0033291717002331. Epub 2017 Aug 22.
PubMed 28826414Indrio F, Martini S, Francavilla R, Corvaglia L, Cristofori F, Mastrolia SA, Neu J, Rautava S, Russo Spena G, Raimondi F, Loverro G. Epigenetic Matters: The Link between Early Nutrition, Microbiome, and Long-term Health Development. Front Pediatr. 2017 Aug 22;5:178. doi: 10.3389/fped.2017.00178. eCollection 2017.
PubMed 28879172Alakaam A, Lemacks J, Yadrick K, Connell C, Choi HW, Newman RG. Maternity Nurses' Knowledge and Practice of Breastfeeding in Mississippi. MCN Am J Matern Child Nurs. 2018 Jul/Aug;43(4):225-230. doi: 10.1097/NMC.0000000000000437.
PubMed 29958205Alakaam A, Lemacks J, Yadrick K, Connell C, Choi HW, Newman RG. Breastfeeding Practices and Barriers to Implementing the Ten Steps to Successful Breastfeeding in Mississippi Hospitals. J Hum Lact. 2018 May;34(2):322-330. doi: 10.1177/0890334417737294. Epub 2017 Nov 20.
PubMed 29156144Agostoni C, Marangoni F, Giovannini M, Galli C, Riva E. Prolonged breast-feeding (six months or more) and milk fat content at six months are associated with higher developmental scores at one year of age within a breast-fed population. Adv Exp Med Biol. 2001;501:137-41. doi: 10.1007/978-1-4615-1371-1_17.
PubMed 11787675
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Interventions to Improve Breastfeeding Rate in African American Mothers
- ClinicalTrials.gov ID
- NCT05503069
- Acronym / sponsor ID
- Breastfeeding DN00486
- Conditions
- Breastfeeding, Breastfeeding, Exclusive
- Keywords
- Breastfeeding, African American Mothers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of Mississippi Medical CenterUniversity, hospital or other
- Study start
- 23 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 16 Aug 2022 (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 percentage of women breastfeeding their newborn babies is very low among minority populations such as African American women in Mississippi. There are good results with initiatives supporting the initiation of breastfeeding after delivery. However, the percentages of continuation of breastfeeding up to 3, 6 or 12 months are still very low in Mississippi. Therefore, this project is proposing to focus on community interventions including social and cultural components to promote and support continuation of breastfeeding.
- The social component will include interventions to promote supportive environments in the workplace for lactating mothers, as well as promoting the use of mother's milk to feed infants in daycare centers.
- The cultural component will focus on educating and raising awareness of the benefit of BF to prevent absenteeism at work, to reduce child illnesses, and to promote healthy child development. The cultural component will target the mother with her family and spouse/partner, employers, and daycare managers.
Detailed description
The hypothesis of whether community interventions supporting breastfeeding practices will increase the rates of continuing breastfeeding at 6 and 12 months among African American women, will be tested with the following specific aims Aim 1: Will test whether providing breast milk pumping machine to lactating mothers will promote continuation of breastfeeding up to 6 and 12 months.
The intervention associated with this aim will include the provision of breast milk pumping machines free of charge to new mothers in the intervention arm at the time of discharge from the hospital. Mothers in the control group will follow standard of care practices, which do not include provision of pumping machines at discharge from the hospital.
Aim 2: Will test whether providing training to improve dietary literacy for lactating mothers will improve continuation of breastfeeding up to 6 and 12 months.
The intervention associated with this aim will include training session on topic related to dietary practices for lactating mothers.
Aim 3: Will test whether providing educational materials describing the benefits breastfeeding to family members, employers, and day care managers will improve continuing breastfeeding up to 6 and 12 months.
Study Design This project will utilize a cohort case-controlled study design. There will be two arms with equally enrolled participants in each arm (1:1). Participants will be allocated in the control and intervention arm utilizing simple randomization with fixed number (n=60) for each arm distributed in group A (control) and group B (intervention). The participants will randomly select an envelope concealing the group label after signed the consent form. The participants will open the envelope in front of research coordinator and the allocation group will be revealed.
The study will target African American women between 25 and 35 years of age who delivered singleton full term babies at the University of Mississippi Medical Center, without any perinatal complications. Babies of both sexes will be included. The Dyads of mother/infant participants will be randomized in the following groups: A- Control arm with n=60 participants, and B- Intervention arm with n=60 participants.
Women in the intervention arm will receive standard of care, which includes basic training in breastfeeding by lactation educators, and the action items related to the intervention.
The intervention will include the following
- Providing a breast milk pumping machine to the mother,
- Facilitating training session to improve dietary literacy for lactating mothers,
- Distribution of educational material describing the benefits of continuing breastfeeding infants up to 12 months of age to family members, employers, day care managers/caregivers.
The control group will receive standard of care, which include basic training by lactation educators.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This project will utilize a cohort case-controlled study design. There will be two arms with equally enrolled participants in each arm (1:1). Participants will be allocated in the control and intervention arm utilizing simple randomization with fixed number (n=60) for each arm distributed in group A (control) and group B (intervention). The participants will randomly select an envelope concealing the group label after signed the consent form.
| Arm | Type | Receives |
|---|---|---|
| Group A - Control | No intervention | –The control group will receive standard of care, which include basic training by lactation educators. |
| Group B - Intervention | Experimental | Behavioral: Interventions with social and cultural componentsWomen in the intervention arm will receive standard of care, which includes basic training in breastfeeding by lactation educators, and the action items related to the intervention. The intervention will include the following 1. Providing a breast milk pumping machine to the mother, 2. Facilitating training session to improve dietary literacy for lactating mothers, 3. Distribution of educational material describing the benefits of continuing breastfeeding infants up to 12 months of age to family members, employers, day care managers/caregivers. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women
- Age: 25 to 35 years of age
- Delivery: Full-term, singleton delivery at UMMC Infants
- Gestational Age: ≥ 37 weeks of gestation
- Sex: Both sexes
Key exclusion criteria (6 listed)
- Women
- Perinatal complication
- Medical indication to withhold breastfeeding practices Infants
- Prematurity
- Medical indication to withhold breastfeeding
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 |
|---|---|---|
| Interventions with social and cultural componentsIntervention Components * Enrollment: We are expecting an enrollment rate of 20 participants per week, and completing enrollment in 6 weeks (n=120 participants) * Baseline Data Collection * Distribution of Educational Materials * Lactation Training * Dietary Literacy Training * Follow Up Data collection: Infant's information on growth and development and Medical History of Infections, GI problems (diarrhea, constipation, colic, vomits, reflux) will be collected at 3, 6 and 12 months. * Follow UP Surveys: Mothers will complete a short survey at 3, 6, and 12 months exploring their breastfeeding behaviors and challenges. * Exit survey: Mothers will be asked to complete an exit survey on month 12 post-enrollment to explore their perception on the participation in the study. | Behavioural | Group B - Intervention |
Primary outcome
Outcomes in Mothers at 3 months
Time frame: At 3 months post enrollment.
-Rates of continuation of breastfeeding at 3 months will be collected during the short phone interview.
Outcomes in Mothers at 6 months
Time frame: At 6 months post enrollment.
-Rates of continuation of breastfeeding at 6 months will be collected during the short phone interview.
Outcomes in Mothers at 12 months
Time frame: At 12 months post enrollment.
-Rates of continuation of breastfeeding at 12 months will be collected during the short phone interview.
Outcomes in Mothers Perceptions on Support at 12 months
Time frame: At 12 months post enrollment.
-Perception of mother on community support to promote breastfeeding will be explored with the exit survey.
Outcomes in Mothers Perceptions on Infant's wellbeing at 12 months
Time frame: At 12 months post enrollment.
-Perception of mother on infant wellbeing associated with breastfeeding practices will explored with exit survey.
Outcomes in Infant's development at 3 months
Time frame: At 3 months post natal
Development and growth using the percentile in growth chart will be collected at 3 months of age.
Outcomes in Infant's development at 6 months
Time frame: At 6 months post natal
Development and growth using the percentile in growth chart will be collected at 6 months of age.
Outcomes in Infant's development at 12 months
Time frame: At 12 months post natal
Development and growth using the percentile in growth chart will be collected at 12 months of age.
Outcomes in Infant's health at 3 months
Time frame: At 3 months post natal
-Incidence of infections and gastrointestinal problems will be collected at 3 months of age.
Outcomes in Infant's health at 6 months
Time frame: At 6 months post natal
-Incidence of infections and gastrointestinal problems will be collected at 6 months of age.
Outcomes in Infant's health at 12 months
Time frame: At 12 months post natal
-Incidence of infections and gastrointestinal problems will be collected at 12 months of age.
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 6 May 2026.
- Background: PubMed 29435577O'Hare C, Kuh D, Hardy R. Association of Early-Life Factors With Life-Course Trajectories of Resting Heart Rate: More Than 6 Decades of Follow-up. JAMA Pediatr. 2018 Apr 2;172(4):e175525. doi: 10.1001/jamapediatrics.2017.5525. Epub 2018 Apr 2.
- Background: PubMed 29358479Schwarzenberg SJ, Georgieff MK; COMMITTEE ON NUTRITION. Advocacy for Improving Nutrition in the First 1000 Days to Support Childhood Development and Adult Health. Pediatrics. 2018 Feb;141(2):e20173716. doi: 10.1542/peds.2017-3716. Epub 2018 Jan 22.
- Background: PubMed 28826414Rantalainen V, Lahti J, Henriksson M, Kajantie E, Mikkonen M, Eriksson JG, Raikkonen K. Association between breastfeeding and better preserved cognitive ability in an elderly cohort of Finnish men. Psychol Med. 2018 Apr;48(6):939-951. doi: 10.1017/S0033291717002331. Epub 2017 Aug 22.
- Background: PubMed 28879172Indrio F, Martini S, Francavilla R, Corvaglia L, Cristofori F, Mastrolia SA, Neu J, Rautava S, Russo Spena G, Raimondi F, Loverro G. Epigenetic Matters: The Link between Early Nutrition, Microbiome, and Long-term Health Development. Front Pediatr. 2017 Aug 22;5:178. doi: 10.3389/fped.2017.00178. eCollection 2017.
- Background: PubMed 29958205Alakaam A, Lemacks J, Yadrick K, Connell C, Choi HW, Newman RG. Maternity Nurses' Knowledge and Practice of Breastfeeding in Mississippi. MCN Am J Matern Child Nurs. 2018 Jul/Aug;43(4):225-230. doi: 10.1097/NMC.0000000000000437.
- Background: PubMed 29156144Alakaam A, Lemacks J, Yadrick K, Connell C, Choi HW, Newman RG. Breastfeeding Practices and Barriers to Implementing the Ten Steps to Successful Breastfeeding in Mississippi Hospitals. J Hum Lact. 2018 May;34(2):322-330. doi: 10.1177/0890334417737294. Epub 2017 Nov 20.
- Background: PubMed 11787675Agostoni C, Marangoni F, Giovannini M, Galli C, Riva E. Prolonged breast-feeding (six months or more) and milk fat content at six months are associated with higher developmental scores at one year of age within a breast-fed population. Adv Exp Med Biol. 2001;501:137-41. doi: 10.1007/978-1-4615-1371-1_17.
- Individual participant dataSharing planned: No. This study is not including a plan to share IPD with other researchers.
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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.
Norma B Ojeda, MD principal investigator
University of Mississippi Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interventions with social and cultural components in people with Breastfeeding and Breastfeeding, Exclusive, run by University of Mississippi Medical Center at 1 site in United States.
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 5 inclusion and 6 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 6 May 2026. 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 United States. 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?
Outcomes in Mothers at 3 months (time frame: At 3 months post enrollment.). The study lists 11 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 NCT05503069, which also lists 7 linked publications.
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 6 May 2026.