BreastfeedingNCT03529630
Breastfeeding Success With the Use of the WHO Syringe Technique for Management of Inverted Nipples in Lactating Women
A study testing Inverted syringe in people with Breastfeeding and Inverted Nipple, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Breastfeeding is the ideal infant nutrition recommended by governmental and medical professional organizations. Yet, women with inverted nipples often face difficulties in breastfeeding that ultimately force them to prematurely terminate breastfeeding. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Breastfeeding, Inverted Nipple
- What is being tested?
- Inverted syringe
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteLebanon
- Study dates
- 1 Jun 2018to 15 Jul 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Healthy pregnant women in their 37th week of gestation or more with grade 1 or 2 inverted nipples
- Able to read and write
- Singleton or twin pregnancy An inverted nipple is defined as a condition in which the nipple is pulled inward into the breast instead of pointing outward, classified according to Han and Hong [11].
Who cannot join
- Women with grade 3 inverted nipples
- Previous breast surgery affecting the breast anatomy
- High risk pregnancies
- Medical conditions that could interfere with breastfeeding such as critical maternal condition
- Newborns with congenital malformations that may interfere with breastfeeding such as esophageal atresia, cleft lip \&/or palate
- Women choosing artificial milk as their preferred infant nutrition.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Breastfeeding Success With the Use of the WHO Syringe Technique for Management of Inverted Nipples in Lactating Women: a Study Protocol for a Randomized Controlled Trial
Breastfeeding is the ideal infant nutrition recommended by governmental and medical professional organizations. Yet, women with inverted nipples often face difficulties in breastfeeding that ultimately force them to prematurely terminate breastfeeding. This open-label randomized clinical trial aims to investigate the effectiveness of the use of the inverted syringe technique on exclusive breastfeeding success in women with inverted nipples, as compared to standard of care.
Read the detailed description
Breastfeeding is the ideal infant nutrition recommended by governmental and medical professional organizations. Its benefits to infants and their mothers are many including protection from infections, certain malignancies and chronic diseases, as well as improved growth, development, cognition and intelligence for children. Yet, women with inverted nipples often face difficulties in breastfeeding that ultimately force them to prematurely terminate breastfeeding. The main treatment of severely inverted nipples is surgical sectioning of the lactiferous ducts at the expense of breast's function. Several conservative measures have also been used for the less severe (grades 1 and 2) inverted nipples such as application of Hoffman Exercises and Woolwich Breast Shields, which have failed to prove their worth. The modified syringe technique is a conservative means for the correction of inverted nipples that was reported in a single case series of 8 women, with high success rates in infant latching (7/8) and exclusive breastfeeding (6/8). It is a simple, inexpensive, portable, safe, and easily learned method that can be performed by mothers as often as required.
This open-label randomized clinical trial aims to investigate the effectiveness of the use of inverted syringe on the 1-month exclusive breastfeeding rate in women with inverted nipples. We hypothesize that in women with grades 1 and 2 inverted nipples, the use of the modified syringe technique soon after delivery, as opposed to the standard of care, will significantly improve breastfeeding rates at 1 month postpartum. We will recruit 100 healthy women at ≥37 weeks of gestation with grades 1 or 2 inverted nipples from the Women's Health Center and the obstetrics outpatient department at AUBMC. They will be randomly allocated to a control group (standard of care) or to the intervention group (inverted syringe). Data will be collected at baseline (socio-demographic variables, inverted nipple grading) and at 1, 3, and 7 days postpartum about infant feeding method, and adverse events. Mothers will be contacted at 1, 3 and 6 months regarding infant feeding method, maternal satisfaction, infant's weight gain and adverse events. The association between breastfeeding success at 1 month and the use of the inverted syringe will be investigated using multivariate regression models. Findings from this study, if positive, will provide much needed evidence for a safe, affordable, readily available and simple intervention to treat inverted nipples and improve breastfeeding practice among affected women.
- Conditions
- Breastfeeding, Inverted Nipple
- Being tested
- Inverted syringe
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inverted syringeOther
Application of mild suction over the mother's inverted nipple using an inverted syringe before each breastfeeding.
| Study group | Role | What they receive |
|---|---|---|
| Inverted syringe | Experimental | Participants in this arm will use of the inverted syringe before each breastfeeding starting from the first feed after delivery and continued as long as needed by the mother. Receives: Other: Inverted syringe |
| Standard of care | No intervention | Participants in the control group will receive standard medical care as dictated by their obstetricians. Any advice regarding infant nutrition or treatment of inverted nipples will be left to the primary physician, including possible use of the inverted syringe technique. . |
What is being measured
The primary outcome is the main question the study is designed to answer.
One month exclusive breastfeeding rate
Proportion of mothers who are exclusively breastfeeding
Measured: 1 month postpartum
Secondary outcomes (13)
3-month exclusive breastfeeding rate
Proportion of mothers who are exclusively breastfeeding
Measured: 3 months postpartum
6-month exclusive breastfeeding rate
Proportion of mothers who are exclusively breastfeeding
Measured: 6 months postpartum
Nipple eversion rate
Proportion of mothers with everted nipples
Measured: 1 month postpartum
Successful latching
Proportion of infants with successful latching while breastfeeding
Measured: 1 month postpartum
1-month mixed feeding rate
Proportion of infants on mixed feeding
Measured: 1 month postpartum
3-month mixed feeding rate
Proportion of infants on mixed feeding
Measured: 3 months postpartum
6-month mixed feeding rate
Proportion of infants on mixed feeding
Measured: 6 months postpartum
Breastfeeding-associated complications
Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
Measured: 1 week postpartum
Breastfeeding-associated complications
Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
Measured: 1 month postpartum
Breastfeeding-associated complications
Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
Measured: 3 months postpartum
Breastfeeding-associated complications
Rate of breastfeeding-associated complications such as sore nipple, mastitis, pain, bleeding, breast engorgement
Measured: 6 months postpartum
Maternal satisfaction with breastfeeding
Maternal satisfaction with breastfeeding assessed with the validated Maternal Breastfeeding Evaluation Scale (MBFES). The scale measures the overall maternal perceived quality with the breastfeeding experience. The scale has a Cronbach's alpha of 0.93. It is composed of 3 subscales: maternal enjoyment/role attainment, infant satisfaction/growth and lifestyle/body image. The corresponding Cronbach's alphas of the subscales are 0.93, 0.88 and 0.80 respectively. The overall score may range from 30 (least satisfied) to 150 (most satisfied).
Measured: 1 week postpartum
Maternal quality of life
Maternal quality of life assessed with the validated Postpartum Quality of Life instrument
Measured: 1 month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start1 Jun 2018
- Primary completion25 Feb 2020
- Study completion15 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Nabulsi, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03529630
- Sponsor's protocol ID
- PED.MN.15
- Status last verified
- Feb 2022
- First submitted
- 8 May 2018
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Sharing of anonymized IPD is possible upon request from the principal investigator after 1 year from publication of the study.
Publications
Binns C, Lee M, Low WY. The Long-Term Public Health Benefits of Breastfeeding. Asia Pac J Public Health. 2016 Jan;28(1):7-14. doi: 10.1177/1010539515624964.
PubMed 26792873Victora CG, Horta BL, Loret de Mola C, Quevedo L, Pinheiro RT, Gigante DP, Goncalves H, Barros FC. Association between breastfeeding and intelligence, educational attainment, and income at 30 years of age: a prospective birth cohort study from Brazil. Lancet Glob Health. 2015 Apr;3(4):e199-205. doi: 10.1016/S2214-109X(15)70002-1.
PubMed 25794674Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
PubMed 26869575Yan J, Liu L, Zhu Y, Huang G, Wang PP. The association between breastfeeding and childhood obesity: a meta-analysis. BMC Public Health. 2014 Dec 13;14:1267. doi: 10.1186/1471-2458-14-1267.
PubMed 25495402Belfort MB, Rifas-Shiman SL, Kleinman KP, Guthrie LB, Bellinger DC, Taveras EM, Gillman MW, Oken E. Infant feeding and childhood cognition at ages 3 and 7 years: Effects of breastfeeding duration and exclusivity. JAMA Pediatr. 2013 Sep;167(9):836-44. doi: 10.1001/jamapediatrics.2013.455.
PubMed 23896931Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.
PubMed 22371471Kramer MS, Kakuma R. Optimal duration of exclusive breastfeeding. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD003517. doi: 10.1002/14651858.CD003517.pub2.
PubMed 22895934SKOOG T. An operation for inverted nipples. Br J Plast Surg. 1952 Apr;5(1):65-9. doi: 10.1016/s0007-1226(52)80008-6. No abstract available.
PubMed 14944774Terrill PJ, Stapleton MJ. The inverted nipple: to cut the ducts or not? Br J Plast Surg. 1991 Jul;44(5):372-7. doi: 10.1016/0007-1226(91)90152-a.
PubMed 1873618Han S, Hong YG. The inverted nipple: its grading and surgical correction. Plast Reconstr Surg. 1999 Aug;104(2):389-95; discussion 396-7. doi: 10.1097/00006534-199908000-00010.
PubMed 10654681Alexander JM, Grant AM, Campbell MJ. Randomised controlled trial of breast shells and Hoffman's exercises for inverted and non-protractile nipples. BMJ. 1992 Apr 18;304(6833):1030-2. doi: 10.1136/bmj.304.6833.1030.
PubMed 1586788McGeorge DD. The "Niplette": an instrument for the non-surgical correction of inverted nipples. Br J Plast Surg. 1994 Jan;47(1):46-9. doi: 10.1016/0007-1226(94)90117-1.
PubMed 8124566Chakrabarti K, Basu S. Management of flat or inverted nipples with simple rubber bands. Breastfeed Med. 2011 Aug;6(4):215-9. doi: 10.1089/bfm.2010.0028. Epub 2011 Jan 8.
PubMed 21214390Kesaree N, Banapurmath CR, Banapurmath S, Shamanur K. Treatment of inverted nipples using a disposable syringe. J Hum Lact. 1993 Mar;9(1):27-9. doi: 10.1177/089033449300900127.
PubMed 8489719Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
PubMed 23295957
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breastfeeding Success With the Use of the WHO Syringe Technique for Management of Inverted Nipples in Lactating Women: a Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03529630
- Acronym / sponsor ID
- PED.MN.15
- Conditions
- Breastfeeding, Inverted Nipple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 15 Jul 2020 (actual)
- First posted
- 18 May 2018 (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.
Breastfeeding is the ideal infant nutrition recommended by governmental and medical professional organizations. Yet, women with inverted nipples often face difficulties in breastfeeding that ultimately force them to prematurely terminate breastfeeding. This open-label randomized clinical trial aims to investigate the effectiveness of the use of the inverted syringe technique on exclusive breastfeeding success in women with inverted nipples, as compared to standard of care.
Detailed description
Breastfeeding is the ideal infant nutrition recommended by governmental and medical professional organizations. Its benefits to infants and their mothers are many including protection from infections, certain malignancies and chronic diseases, as well as improved growth, development, cognition and intelligence for children. Yet, women with inverted nipples often face difficulties in breastfeeding that ultimately force them to prematurely terminate breastfeeding. The main treatment of severely inverted nipples is surgical sectioning of the lactiferous ducts at the expense of breast's function. Several conservative measures have also been used for the less severe (grades 1 and 2) inverted nipples such as application of Hoffman Exercises and Woolwich Breast Shields, which have failed to prove their worth. The modified syringe technique is a conservative means for the correction of inverted nipples that was reported in a single case series of 8 women, with high success rates in infant latching (7/8) and exclusive breastfeeding (6/8). It is a simple, inexpensive, portable, safe, and easily learned method that can be performed by mothers as often as required.
This open-label randomized clinical trial aims to investigate the effectiveness of the use of inverted syringe on the 1-month exclusive breastfeeding rate in women with inverted nipples. We hypothesize that in women with grades 1 and 2 inverted nipples, the use of the modified syringe technique soon after delivery, as opposed to the standard of care, will significantly improve breastfeeding rates at 1 month postpartum. We will recruit 100 healthy women at ≥37 weeks of gestation with grades 1 or 2 inverted nipples from the Women's Health Center and the obstetrics outpatient department at AUBMC. They will be randomly allocated to a control group (standard of care) or to the intervention group (inverted syringe). Data will be collected at baseline (socio-demographic variables, inverted nipple grading) and at 1, 3, and 7 days postpartum about infant feeding method, and adverse events. Mothers will be contacted at 1, 3 and 6 months regarding infant feeding method, maternal satisfaction, infant's weight gain and adverse events. The association between breastfeeding success at 1 month and the use of the inverted syringe will be investigated using multivariate regression models. Findings from this study, if positive, will provide much needed evidence for a safe, affordable, readily available and simple intervention to treat inverted nipples and improve breastfeeding practice among affected women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inverted syringe | Experimental | Other: Inverted syringeParticipants in this arm will use of the inverted syringe before each breastfeeding starting from the first feed after delivery and continued as long as needed by the mother. |
| Standard of care | No intervention | –Participants in the control group will receive standard medical care as dictated by their obstetricians. Any advice regarding infant nutrition or treatment of inverted nipples will be left to the primary physician, including possible use of the inverted syringe technique. . |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy pregnant women in their 37th week of gestation or more with grade 1 or 2 inverted nipples
- Able to read and write
- Singleton or twin pregnancy An inverted nipple is defined as a condition in which the nipple is pulled inward into the breast instead of pointing outward, classified according to Han and Hong [11].
Key exclusion criteria (6 listed)
- Women with grade 3 inverted nipples
- Previous breast surgery affecting the breast anatomy
- High risk pregnancies
- Medical conditions that could interfere with breastfeeding such as critical maternal condition
- Newborns with congenital malformations that may interfere with breastfeeding such as esophageal atresia, cleft lip \&/or palate
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 |
|---|---|---|
| Inverted syringeApplication of mild suction over the mother's inverted nipple using an inverted syringe before each breastfeeding. | Other | Inverted syringe |
Primary outcome
One month exclusive breastfeeding rate
Time frame: 1 month postpartum
Proportion of mothers who are exclusively breastfeeding
13 secondary outcomes
3-month exclusive breastfeeding rate
Time frame: 3 months postpartum
6-month exclusive breastfeeding rate
Time frame: 6 months postpartum
Nipple eversion rate
Time frame: 1 month postpartum
Successful latching
Time frame: 1 month postpartum
1-month mixed feeding rate
Time frame: 1 month postpartum
3-month mixed feeding rate
Time frame: 3 months postpartum
6-month mixed feeding rate
Time frame: 6 months postpartum
Breastfeeding-associated complications
Time frame: 1 week postpartum
Breastfeeding-associated complications
Time frame: 1 month postpartum
Breastfeeding-associated complications
Time frame: 3 months postpartum
Breastfeeding-associated complications
Time frame: 6 months postpartum
Maternal satisfaction with breastfeeding
Time frame: 1 week postpartum
Maternal quality of life
Time frame: 1 month postpartum
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 2 Mar 2022.
- Background: PubMed 26792873Binns C, Lee M, Low WY. The Long-Term Public Health Benefits of Breastfeeding. Asia Pac J Public Health. 2016 Jan;28(1):7-14. doi: 10.1177/1010539515624964.
- Background: PubMed 25794674Victora CG, Horta BL, Loret de Mola C, Quevedo L, Pinheiro RT, Gigante DP, Goncalves H, Barros FC. Association between breastfeeding and intelligence, educational attainment, and income at 30 years of age: a prospective birth cohort study from Brazil. Lancet Glob Health. 2015 Apr;3(4):e199-205. doi: 10.1016/S2214-109X(15)70002-1.
- Background: PubMed 26869575Victora CG, Bahl R, Barros AJ, Franca GV, Horton S, Krasevec J, Murch S, Sankar MJ, Walker N, Rollins NC; Lancet Breastfeeding Series Group. Breastfeeding in the 21st century: epidemiology, mechanisms, and lifelong effect. Lancet. 2016 Jan 30;387(10017):475-90. doi: 10.1016/S0140-6736(15)01024-7.
- Background: PubMed 25495402Yan J, Liu L, Zhu Y, Huang G, Wang PP. The association between breastfeeding and childhood obesity: a meta-analysis. BMC Public Health. 2014 Dec 13;14:1267. doi: 10.1186/1471-2458-14-1267.
- Background: PubMed 23896931Belfort MB, Rifas-Shiman SL, Kleinman KP, Guthrie LB, Bellinger DC, Taveras EM, Gillman MW, Oken E. Infant feeding and childhood cognition at ages 3 and 7 years: Effects of breastfeeding duration and exclusivity. JAMA Pediatr. 2013 Sep;167(9):836-44. doi: 10.1001/jamapediatrics.2013.455.
- Background: PubMed 22371471Section on Breastfeeding. Breastfeeding and the use of human milk. Pediatrics. 2012 Mar;129(3):e827-41. doi: 10.1542/peds.2011-3552. Epub 2012 Feb 27.
- Background: PubMed 22895934Kramer MS, Kakuma R. Optimal duration of exclusive breastfeeding. Cochrane Database Syst Rev. 2012 Aug 15;2012(8):CD003517. doi: 10.1002/14651858.CD003517.pub2.
- Background: PubMed 14944774SKOOG T. An operation for inverted nipples. Br J Plast Surg. 1952 Apr;5(1):65-9. doi: 10.1016/s0007-1226(52)80008-6. No abstract available.
- Background: PubMed 1873618Terrill PJ, Stapleton MJ. The inverted nipple: to cut the ducts or not? Br J Plast Surg. 1991 Jul;44(5):372-7. doi: 10.1016/0007-1226(91)90152-a.
- Background: PubMed 10654681Han S, Hong YG. The inverted nipple: its grading and surgical correction. Plast Reconstr Surg. 1999 Aug;104(2):389-95; discussion 396-7. doi: 10.1097/00006534-199908000-00010.
- Background: PubMed 1586788Alexander JM, Grant AM, Campbell MJ. Randomised controlled trial of breast shells and Hoffman's exercises for inverted and non-protractile nipples. BMJ. 1992 Apr 18;304(6833):1030-2. doi: 10.1136/bmj.304.6833.1030.
- Background: PubMed 8124566McGeorge DD. The "Niplette": an instrument for the non-surgical correction of inverted nipples. Br J Plast Surg. 1994 Jan;47(1):46-9. doi: 10.1016/0007-1226(94)90117-1.
- Individual participant dataSharing planned: Yes. Sharing of anonymized IPD is possible upon request from the principal investigator after 1 year from publication of the study.
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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 Inverted syringe in people with Breastfeeding and Inverted Nipple, run by American University of Beirut Medical Center at 1 site in Lebanon.
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 3 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 2 Mar 2022. 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 Lebanon. 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?
One month exclusive breastfeeding rate (time frame: 1 month postpartum). 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 NCT03529630, which also lists 21 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 2 Mar 2022.