Premature LungsM3DPREMATNCT06224816
Clinical Trial for the Evaluation of Customized 3D Printed NIV Nasal Masks in Premature Infants
A study testing Custom 3D mask (3DM) application in neonate and Traditional mask (TM) application in neonate in people with Premature Lungs, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
Trial summary
Clinical trial with crossed groups, open, masked for the evaluation of the main outcome. Inclusion of all premature infants with a birth weight less than 1500 g requiring Non-invasive Ventilation (NIV). Premature will be randomised to start alternatively with MT or 3DM. Read more about this study
- Who is it for?
- Ages 0 to 30 days
- Conditions the study is for
- Premature Lungs
- What is being tested?
- Custom 3D mask (3DM) application in neonate and Traditional mask (TM) application in neonate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- 16 Apr 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 0 to 30 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn prematurity
- Age: less than 30 days of life
- Required respiratory support with non-invasive ventilation (NIV)
- Premature infant has not been on NIV for more than 3 days before being included in the trial.
- Signature of the Informed Consent (IC)
Who cannot join
- Failure to meet entry criteria
- Cyanotic congenital heart disease diagnosis
- Presence of serious malformations
- Presence of airway malformations
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
Maria Teresa Moral Pumarega, 649921733 ext. +34, mmoralp@salud.madrid.org
About this study
Official title: Clinical Trial to Assess the Clinical Impact, Efficacy and Safety of Customized Nasal Masks Designed by 3D Printing During Non-invasive Ventilation in Premature Infants
Clinical trial with crossed groups, open, masked for the evaluation of the main outcome. Inclusion of all premature infants with a birth weight less than 1500 g requiring Non-invasive Ventilation (NIV).
Premature will be randomised to start alternatively with MT or 3DM. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days.
To compare the time in which preterm maintain SatO2 below 85% with the 3DM versus the traditional mask (TM) in preterm < 1500 g. Other secondary objectives regarding ventilation enhancement will be assessed, such as the number of bradycardias, cardiorespiratory arrest and need for resuscitation in the context of apnea. Also, skin lesions of the nose resulting from the pressure applied by any of the masks (TM or 3DM) and the need for analgesia and/or sedation for pain control or discomfort will be assessed. Parental perception and satisfaction will be assessed.
Read the detailed description
Improvement and optimization of non-invasive ventilation (NIV) in preterm and low birth weight infants is essential in order to reduce morbidity. By the use of 3D printing design (3DM), these infants would be provided with customized nasal masks, according to their particular anatomical features while on NIV. This would lead to a greater stabilization of the respiratory system, decreased apnea spells, oxygen desaturation and bradycardia, less need for intubation and less skin nose injury, all of which might improve neurodevelopmental outcomes.
- Conditions
- Premature Lungs
- Being tested
- Custom 3D mask (3DM) application in neonate, Traditional mask (TM) application in neonate
- Keywords
- Neonatology, Nasal mask, 3D printing, Additive manufacturing, Newborn, Premature, Prematurity, Neonate, Non-Invasive Ventilation (NIV), Oxygen saturation, SolidWorks, 3D scanner, Customized device, Continuous positive airway pressure (CPAP)
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom 3D mask (3DM) application in neonateDevice
Premature infants with a birth weight less than 1500 g r first received 3D mask during 4 hour, then crossed over to traditional mask.
Traditional mask (TM) application in neonateDevice
Premature infants with a birth weight less than 1500 g r first received traditional mask during 4 hours, then crossed over to 3D mask.
| Study group | Role | What they receive |
|---|---|---|
| 3D Mask (3DM) | Experimental | Custom 3D mask (3DM) application in neonate during 4 hours. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days. Receives: Device: Custom 3D mask (3DM) application in neonate; Device: Traditional mask (TM) application in neonate |
| Traditional Mask (TM) | Active comparator | Traditional Mask (TM) application in neonate during 4 hours. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days. Receives: Device: Custom 3D mask (3DM) application in neonate; Device: Traditional mask (TM) application in neonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in which preterm maintain SatO2 below 85%.
To compare the time in which preterm maintain SatO2 below 85%.in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).
Measured: 7 days
Secondary outcomes (5)
Time in which preterm maintain bradycardias.
To compare the time in which preterm maintain bradycardias - heart rate below 100 beats per minute - that occur in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).
Measured: 7 days
Time in which preterm maintain SatO2 below 75%.
To compare the time in which preterm maintain SatO2 below 75%.in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).
Measured: 7 days
Number of times requiring cardiopulmonary resuscitation
Compare the number of times requiring cardiorespiratory resuscitation with self-inflating bag in the context of apnea pause or severe desaturation in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).
Measured: 7 days
Appearance of cutaneous lesions in nasal region or mucosa
To compare the appearance of cutaneous lesions in the nasal region or nasal mucosa as a consequence of the pressure exerted by any of the masks, indicating the location and degree of the wound in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).
Measured: 7 days
Pain assessment with scoring scale.
To compare the degrees of pain, measured in the neonatal pain scale PIPP-R (Premature Infant Pain Profile-Revised), obtained every 12 hours in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM). Regarding the PIPP-R scale, the minimum score is 1 and the maximum is 21. Scores between 1-6 correspond to mild pain, 7-11 moderate pain, and 12-21 severe pain.
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study start16 Apr 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Premature LungsStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario 12 de Octubre
- Sponsor type
- University, hospital or other
- Collaborators
- ISCIII
- Responsible party
- Principal investigator, María Teresa Moral Pumarega, Hospital Universitario 12 de Octubre
- Investigators
- María Teresa Moral Pumarega, Principal investigator, Hospital Universitario 12 de OctubreAntonio Martín González, Mechanical Engineering, Study chair, Hospital Universitario 12 de Octubre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06224816
- Sponsor's protocol ID
- M3DPREMAT
- Acronym
- M3DPREMAT
- Status last verified
- Apr 2024
- First submitted
- 20 Dec 2023
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Al-Ramahi J, Luo H, Fang R, Chou A, Jiang J, Kille T. Development of an Innovative 3D Printed Rigid Bronchoscopy Training Model. Ann Otol Rhinol Laryngol. 2016 Dec;125(12):965-969. doi: 10.1177/0003489416667742. Epub 2016 Sep 7.
PubMed 27605436Zheng J, He H, Kuang W, Yuan W. Presurgical nasoalveolar molding with 3D printing for a patient with unilateral cleft lip, alveolus, and palate. Am J Orthod Dentofacial Orthop. 2019 Sep;156(3):412-419. doi: 10.1016/j.ajodo.2018.04.031.
PubMed 31474271Hadeed K, Dulac Y, Acar P. Three-dimensional printing of a complex CHD to plan surgical repair. Cardiol Young. 2016 Oct;26(7):1432-4. doi: 10.1017/S1047951116000755. Epub 2016 Jun 20.
PubMed 27321706Xu JJ, Luo YJ, Wang JH, Xu WZ, Shi Z, Fu JZ, Shu Q. Patient-specific three-dimensional printed heart models benefit preoperative planning for complex congenital heart disease. World J Pediatr. 2019 Jun;15(3):246-254. doi: 10.1007/s12519-019-00228-4. Epub 2019 Feb 22.
PubMed 30796731Zhao H, Lin G, Seong YH, Shi J, Xu J, Huang W. Anthropometric research of congenital auricular deformities for newborns. J Matern Fetal Neonatal Med. 2019 Apr;32(7):1176-1183. doi: 10.1080/14767058.2017.1402877. Epub 2017 Dec 8.
PubMed 29219007Minocchieri S, Burren JM, Bachmann MA, Stern G, Wildhaber J, Buob S, Schindel R, Kraemer R, Frey UP, Nelle M. Development of the premature infant nose throat-model (PrINT-Model): an upper airway replica of a premature neonate for the study of aerosol delivery. Pediatr Res. 2008 Aug;64(2):141-6. doi: 10.1203/PDR.0b013e318175dcfa.
PubMed 18391845Saugstad OD, Aune D. Optimal oxygenation of extremely low birth weight infants: a meta-analysis and systematic review of the oxygen saturation target studies. Neonatology. 2014;105(1):55-63. doi: 10.1159/000356561. Epub 2013 Nov 15.
PubMed 24247112Stenson BJ. Oxygen targets for preterm infants. Neonatology. 2013;103(4):341-5. doi: 10.1159/000349936. Epub 2013 May 31.
PubMed 23736013Bose CL, Dammann CE, Laughon MM. Bronchopulmonary dysplasia and inflammatory biomarkers in the premature neonate. Arch Dis Child Fetal Neonatal Ed. 2008 Nov;93(6):F455-61. doi: 10.1136/adc.2007.121327. Epub 2008 Aug 1.
PubMed 18676410Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
PubMed 30974433Sweet DG, Carnielli VP, Greisen G, Hallman M, Klebermass-Schrehof K, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2022 Update. Neonatology. 2023;120(1):3-23. doi: 10.1159/000528914. Epub 2023 Feb 15.
PubMed 36863329Roh S, Parekh DP, Bharti B, Stoyanov SD, Velev OD. 3D Printing by Multiphase Silicone/Water Capillary Inks. Adv Mater. 2017 Aug;29(30). doi: 10.1002/adma.201701554. Epub 2017 Jun 7.
PubMed 28590510Hinton TJ, Hudson A, Pusch K, Lee A, Feinberg AW. 3D Printing PDMS Elastomer in a Hydrophilic Support Bath via Freeform Reversible Embedding. ACS Biomater Sci Eng. 2016 Oct 10;2(10):1781-1786. doi: 10.1021/acsbiomaterials.6b00170. Epub 2016 May 4.
PubMed 27747289Bhattacharjee N, Parra-Cabrera C, Kim YT, Kuo AP, Folch A. Desktop-Stereolithography 3D-Printing of a Poly(dimethylsiloxane)-Based Material with Sylgard-184 Properties. Adv Mater. 2018 May;30(22):e1800001. doi: 10.1002/adma.201800001. Epub 2018 Apr 14.
PubMed 29656459Clarke A, Yeomans E, Elsayed K, Medhurst A, Berger P, Skuza E, Tan K. A randomised crossover trial of clinical algorithm for oxygen saturation targeting in preterm infants with frequent desaturation episodes. Neonatology. 2015;107(2):130-6. doi: 10.1159/000368295. Epub 2014 Dec 12.
PubMed 25531240
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial to Assess the Clinical Impact, Efficacy and Safety of Customized Nasal Masks Designed by 3D Printing During Non-invasive Ventilation in Premature Infants
- ClinicalTrials.gov ID
- NCT06224816
- Acronym / sponsor ID
- M3DPREMAT / M3DPREMAT
- Conditions
- Premature Lungs
- Keywords
- Neonatology, Nasal mask, 3D printing, Additive manufacturing, Newborn, Premature, Prematurity, Neonate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Universitario 12 de OctubreUniversity, hospital or other
- Collaborators
- ISCIII
- Study start
- 16 Apr 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 25 Jan 2024 (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.
Clinical trial with crossed groups, open, masked for the evaluation of the main outcome. Inclusion of all premature infants with a birth weight less than 1500 g requiring Non-invasive Ventilation (NIV).
Premature will be randomised to start alternatively with MT or 3DM. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days.
To compare the time in which preterm maintain SatO2 below 85% with the 3DM versus the traditional mask (TM) in preterm < 1500 g. Other secondary objectives regarding ventilation enhancement will be assessed, such as the number of bradycardias, cardiorespiratory arrest and need for resuscitation in the context of apnea. Also, skin lesions of the nose resulting from the pressure applied by any of the masks (TM or 3DM) and the need for analgesia and/or sedation for pain control or discomfort will be assessed. Parental perception and satisfaction will be assessed.
Detailed description
Improvement and optimization of non-invasive ventilation (NIV) in preterm and low birth weight infants is essential in order to reduce morbidity. By the use of 3D printing design (3DM), these infants would be provided with customized nasal masks, according to their particular anatomical features while on NIV. This would lead to a greater stabilization of the respiratory system, decreased apnea spells, oxygen desaturation and bradycardia, less need for intubation and less skin nose injury, all of which might improve neurodevelopmental outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D Mask (3DM) | Experimental | Device: Custom 3D mask (3DM) application in neonate, Device: Traditional mask (TM) application in neonateCustom 3D mask (3DM) application in neonate during 4 hours. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days. |
| Traditional Mask (TM) | Active comparator | Device: Custom 3D mask (3DM) application in neonate, Device: Traditional mask (TM) application in neonateTraditional Mask (TM) application in neonate during 4 hours. Each patient included will be their own control at the same time, receiving each of the different mask models every 4 hours alternately. The study period will be a maximum of 7 days. |
Who may qualify
- Ages
- 0 to 30 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Newborn prematurity
- Age: less than 30 days of life
- Required respiratory support with non-invasive ventilation (NIV)
- Premature infant has not been on NIV for more than 3 days before being included in the trial.
- Signature of the Informed Consent (IC)
Key exclusion criteria (4 listed)
- Failure to meet entry criteria
- Cyanotic congenital heart disease diagnosis
- Presence of serious malformations
- Presence of airway malformations
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 |
|---|---|---|
| Custom 3D mask (3DM) application in neonatePremature infants with a birth weight less than 1500 g r first received 3D mask during 4 hour, then crossed over to traditional mask. | Device | 3D Mask (3DM), Traditional Mask (TM) |
| Traditional mask (TM) application in neonatePremature infants with a birth weight less than 1500 g r first received traditional mask during 4 hours, then crossed over to 3D mask. | Device | 3D Mask (3DM), Traditional Mask (TM) |
Primary outcome
Time in which preterm maintain SatO2 below 85%.
Time frame: 7 days
To compare the time in which preterm maintain SatO2 below 85%.in the period of time that customized 3D printed nasal mask (3DM) is used versus traditional nasal mask (TM).
5 secondary outcomes
Time in which preterm maintain bradycardias.
Time frame: 7 days
Time in which preterm maintain SatO2 below 75%.
Time frame: 7 days
Number of times requiring cardiopulmonary resuscitation
Time frame: 7 days
Appearance of cutaneous lesions in nasal region or mucosa
Time frame: 7 days
Pain assessment with scoring scale.
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2024.
- Background: PubMed 27605436Al-Ramahi J, Luo H, Fang R, Chou A, Jiang J, Kille T. Development of an Innovative 3D Printed Rigid Bronchoscopy Training Model. Ann Otol Rhinol Laryngol. 2016 Dec;125(12):965-969. doi: 10.1177/0003489416667742. Epub 2016 Sep 7.
- Background: PubMed 31474271Zheng J, He H, Kuang W, Yuan W. Presurgical nasoalveolar molding with 3D printing for a patient with unilateral cleft lip, alveolus, and palate. Am J Orthod Dentofacial Orthop. 2019 Sep;156(3):412-419. doi: 10.1016/j.ajodo.2018.04.031.
- Background: PubMed 27321706Hadeed K, Dulac Y, Acar P. Three-dimensional printing of a complex CHD to plan surgical repair. Cardiol Young. 2016 Oct;26(7):1432-4. doi: 10.1017/S1047951116000755. Epub 2016 Jun 20.
- Background: PubMed 30796731Xu JJ, Luo YJ, Wang JH, Xu WZ, Shi Z, Fu JZ, Shu Q. Patient-specific three-dimensional printed heart models benefit preoperative planning for complex congenital heart disease. World J Pediatr. 2019 Jun;15(3):246-254. doi: 10.1007/s12519-019-00228-4. Epub 2019 Feb 22.
- Background: PubMed 29219007Zhao H, Lin G, Seong YH, Shi J, Xu J, Huang W. Anthropometric research of congenital auricular deformities for newborns. J Matern Fetal Neonatal Med. 2019 Apr;32(7):1176-1183. doi: 10.1080/14767058.2017.1402877. Epub 2017 Dec 8.
- Background: PubMed 18391845Minocchieri S, Burren JM, Bachmann MA, Stern G, Wildhaber J, Buob S, Schindel R, Kraemer R, Frey UP, Nelle M. Development of the premature infant nose throat-model (PrINT-Model): an upper airway replica of a premature neonate for the study of aerosol delivery. Pediatr Res. 2008 Aug;64(2):141-6. doi: 10.1203/PDR.0b013e318175dcfa.
- Background: PubMed 24247112Saugstad OD, Aune D. Optimal oxygenation of extremely low birth weight infants: a meta-analysis and systematic review of the oxygen saturation target studies. Neonatology. 2014;105(1):55-63. doi: 10.1159/000356561. Epub 2013 Nov 15.
- Background: PubMed 23736013Stenson BJ. Oxygen targets for preterm infants. Neonatology. 2013;103(4):341-5. doi: 10.1159/000349936. Epub 2013 May 31.
- Background: PubMed 18676410Bose CL, Dammann CE, Laughon MM. Bronchopulmonary dysplasia and inflammatory biomarkers in the premature neonate. Arch Dis Child Fetal Neonatal Ed. 2008 Nov;93(6):F455-61. doi: 10.1136/adc.2007.121327. Epub 2008 Aug 1.
- Background: PubMed 30974433Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
- Background: PubMed 36863329Sweet DG, Carnielli VP, Greisen G, Hallman M, Klebermass-Schrehof K, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome: 2022 Update. Neonatology. 2023;120(1):3-23. doi: 10.1159/000528914. Epub 2023 Feb 15.
- Background: PubMed 28590510Roh S, Parekh DP, Bharti B, Stoyanov SD, Velev OD. 3D Printing by Multiphase Silicone/Water Capillary Inks. Adv Mater. 2017 Aug;29(30). doi: 10.1002/adma.201701554. Epub 2017 Jun 7.
- Individual participant dataSharing planned: Undecided
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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.
María Teresa Moral Pumarega principal investigator
Hospital Universitario 12 de Octubre
Antonio Martín González, Mechanical Engineering study chair
Hospital Universitario 12 de Octubre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom 3D mask (3DM) application in neonate and Traditional mask (TM) application in neonate in people with Premature Lungs, run by Hospital Universitario 12 de Octubre at 1 site in Spain.
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 4 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: looking for participants now, as of the sponsor's last update on 18 Apr 2024. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact María Teresa Moral Pumarega (649921733 ext. +34, mmoralp@salud.madrid.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in which preterm maintain SatO2 below 85%. (time frame: 7 days). 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 NCT06224816, which also lists 17 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 18 Apr 2024.