SurfactantSALTINCT07030270
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
A study testing Surfactant Administration through Laryngeal or Supraglottic Airway and Surfactant Administration through Thin Catheter in people with Surfactant and Respiratory Distress Syndrome (Neonatal), run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better. Surfactant can be given using a thin tube ("Less Invasive Surfactant Administration", called the LISA method) or through a small airway device placed in the baby's throat above the… Read more about this study
- Who is it for?
- Ages 0 to 72 hours
- Conditions the study is for
- Surfactant, Respiratory Distress Syndrome (Neonatal)
- What is being tested?
- Surfactant Administration through Laryngeal or Supraglottic Airway and Surfactant Administration through Thin Catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Aug 2026to Jun 2030
- 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 72 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All preterm infants born between 29-36 weeks' gestation.
- Infants with birthweight greater than or equal to 750 grams and admitted to the NICU on CPAP for respiratory support requiring at least FiO2 25% and qualify for LISA procedure
Who cannot join
- Infants who require intubation prior to surfactant therapy
- Infants with known severe congenital anomalies (complex congenital heart disease, airway and central nervous system anomalies)
- Infants whose birth weight is less than 750 grams or oropharynx unable to accommodate laryngeal mask airways
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kathryn Mazioniene, R.N. contact
United States1 site, 1 recruiting
- Recruiting
Parkland Health and Hospital Systems
Dallas, Texas, 75235
Melody Chiu, MD
About this study
Official title: A Clinical Trial Comparing Surfactant Administration Through Supraglottic Airway or Thin Catheter for Preterm Infants
What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better. Surfactant can be given using a thin tube ("Less Invasive Surfactant Administration", called the LISA method) or through a small airway device placed in the baby's throat above the vocal cords ("Surfactant Administration through Laryngeal or Supraglottic Airway", called the SALSA method). The goal is to see which method is safer and more effective for preterm infants who are born at 29-36 weeks of pregnancy and have trouble breathing.
What is the main question (hypothesis)? Infants who receive surfactant using the SALSA method will have fewer heart rate and breathing-related problems than those who receive it using the LISA method.
What are the aims? Aim 1: Are babies in the SALSA group less likely to have low heart rate or low oxygen levels during the procedure compared to babies in the LISA group? Aim 2: Do fewer babies in the SALSA group need to be put on a breathing machine within the first 72 hours of life? Aim 3: Does the SALSA method help reduce the overall time babies need breathing support and lower the cost of their care in the NICU?
- Being tested
- Surfactant Administration through Laryngeal or Supraglottic Airway, Surfactant Administration through Thin Catheter
- Keywords
- preterm infants, surfactant therapy, respiratory distress syndrome
- Medical subject headings
- Pulmonary Atelectasis, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surfactant Administration through Laryngeal or Supraglottic AirwayProcedure or surgery
Surfactant Administration through Supraglottic Airway Devices
-AerVia sizes S, M, L, XL
Surfactant Administration through Thin CatheterProcedure or surgery
Thin Catheter
| Study group | Role | What they receive |
|---|---|---|
| Surfactant Administration through Laryngeal or Supraglottic Airway | Experimental | Not described Receives: Procedure: Surfactant Administration through Laryngeal or Supraglottic Airway |
| Surfactant Administration through Thin Catheter | Active comparator | Not described Receives: Procedure: Surfactant Administration through Thin Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined bradycardia (heart rate < 100 for > 10 seconds) and hypoxemia (SpO2 < 80% for > 30 seconds) during surfactant administration
- Bradycardia: defined as heart rate < 100 beats per minute for > 10 seconds. Heart rate will be obtained from participant's heart rate monitor.
- Hypoxemia: oxygen saturation (SpO2) =< 80% for > 30 seconds. Oxygen saturation will be obtained from participant's pulse oximeter monitor
- Events will be recorded by bedside respiratory therapy and/or bedside nurse during the procedure
Measured: Time of laryngoscope or supraglottic airway device insertion to removal of device
Secondary outcomes (4)
Procedural success rate on first attempt
- Procedure attempt is defined at the introduction of laryngoscope blade into mouth for LISA, supraglottic airway for SALSA.
- Procedural success is defined by the ability to insert catheter or laryngeal mask airway and administer surfactant with less than 25% of surfactant aspirated from the stomach post administration
- Rate will be calculated as a percentage of participants in each arm
Measured: At time of surfactant administration procedure
Intubation rate
- Rate will be calculated as a percentage of participants in each arm Invasive mechanical ventilation within first 72 hours of life after surfactant
- Participants' need for and timing of intubation will be obtained from electronic medical record
Measured: From time of procedure to 72 hours of life
Mean number of attempts required
Procedure attempt will be defined as introduction of laryngoscope blade into mouth for LISA and introduction of supraglottic airway into mouth for SALSA.
Measured: At time of surfactant administration
Total duration of CPAP and mechanical ventilation days
Total numbers of days on continuous end positive expiratory pressure (CPAP) and invasive mechanical ventilation
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start5 Aug 2026
- Primary completionJul 2028 (estimated)
- Study completionJun 2030 (estimated)
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 SurfactantStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Melody Chiu, University of Texas Southwestern Medical Center
- Investigators
- Melody Chiu, M.D., Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07030270
- Sponsor's protocol ID
- STU20250018
- Acronym
- SALTI
- Status last verified
- Aug 2026
- First submitted
- 29 May 2025
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be collected and de-identified at the time of analysis. IPD availability does not to enhance study results.
Publications
Roberts CT, Manley BJ, O'Shea JE, Stark M, Andersen C, Davis PG, Buckmaster A. Supraglottic airway devices for administration of surfactant to newborn infants with respiratory distress syndrome: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2021 May;106(3):336-341. doi: 10.1136/archdischild-2020-319804. Epub 2020 Sep 28.
PubMed 32989046Roberts KD, Brown R, Lampland AL, Leone TA, Rudser KD, Finer NN, Rich WD, Merritt TA, Czynski AJ, Kessel JM, Tipnis SM, Stepka EC, Mammel MC. Laryngeal Mask Airway for Surfactant Administration in Neonates: A Randomized, Controlled Trial. J Pediatr. 2018 Feb;193:40-46.e1. doi: 10.1016/j.jpeds.2017.09.068. Epub 2017 Nov 22.
PubMed 29174079Wyckoff MH, Greif R, Morley PT, Ng KC, Olasveengen TM, Singletary EM, Soar J, Cheng A, Drennan IR, Liley HG, Scholefield BR, Smyth MA, Welsford M, Zideman DA, Acworth J, Aickin R, Andersen LW, Atkins D, Berry DC, Bhanji F, Bierens J, Borra V, Bottiger BW, Bradley RN, Bray JE, Breckwoldt J, Callaway CW, Carlson JN, Cassan P, Castren M, Chang WT, Charlton NP, Phil Chung S, Considine J, Costa-Nobre DT, Couper K, Couto TB, Dainty KN, Davis PG, de Almeida MF, de Caen AR, Deakin CD, Djarv T, Donnino MW, Douma MJ, Duff JP, Dunne CL, Eastwood K, El-Naggar W, Fabres JG, Fawke J, Finn J, Foglia EE, Folke F, Gilfoyle E, Goolsby CA, Granfeldt A, Guerguerian AM, Guinsburg R, Hirsch KG, Holmberg MJ, Hosono S, Hsieh MJ, Hsu CH, Ikeyama T, Isayama T, Johnson NJ, Kapadia VS, Kawakami MD, Kim HS, Kleinman M, Kloeck DA, Kudenchuk PJ, Lagina AT, Lauridsen KG, Lavonas EJ, Lee HC, Lin YJ, Lockey AS, Maconochie IK, Madar RJ, Malta Hansen C, Masterson S, Matsuyama T, McKinlay CJD, Meyran D, Morgan P, Morrison LJ, Nadkarni V, Nakwa FL, Nation KJ, Nehme Z, Nemeth M, Neumar RW, Nicholson T, Nikolaou N, Nishiyama C, Norii T, Nuthall GA, O'Neill BJ, Gene Ong YK, Orkin AM, Paiva EF, Parr MJ, Patocka C, Pellegrino JL, Perkins GD, Perlman JM, Rabi Y, Reis AG, Reynolds JC, Ristagno G, Rodriguez-Nunez A, Roehr CC, Rudiger M, Sakamoto T, Sandroni C, Sawyer TL, Schexnayder SM, Schmolzer GM, Schnaubelt S, Semeraro F, Skrifvars MB, Smith CM, Sugiura T, Tijssen JA, Trevisanuto D, Van de Voorde P, Wang TL, Weiner GM, Wyllie JP, Yang CW, Yeung J, Nolan JP, Berg KM; Collaborators. 2022 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations: Summary From the Basic Life Support; Advanced Life Support; Pediatric Life Support; Neonatal Life Support; Education, Implementation, and Teams; and First Aid Task Forces. Resuscitation. 2022 Dec;181:208-288. doi: 10.1016/j.resuscitation.2022.10.005. Epub 2022 Nov 3.
PubMed 36336195Kakkilaya V, Gautham KS. Should less invasive surfactant administration (LISA) become routine practice in US neonatal units? Pediatr Res. 2023 Apr;93(5):1188-1198. doi: 10.1038/s41390-022-02265-8. Epub 2022 Aug 19.
PubMed 35986148Kurepa D, Perveen S, Lipener Y, Kakkilaya V. The use of less invasive surfactant administration (LISA) in the United States with review of the literature. J Perinatol. 2019 Mar;39(3):426-432. doi: 10.1038/s41372-018-0302-9. Epub 2019 Jan 11.
PubMed 30635595Kakkilaya VB, Weydig HM, Smithhart WE, Renfro SD, Garcia KM, Brown CM, He H, Wagner SA, Metoyer GC, Brown LS, Kapadia VS, Savani RC, Jaleel MA. Decreasing Continuous Positive Airway Pressure Failure in Preterm Infants. Pediatrics. 2021 Oct;148(4):e2020014191. doi: 10.1542/peds.2020-014191. Epub 2021 Sep 22.
PubMed 34552000Committee on Fetus and Newborn; American Academy of Pediatrics. Respiratory support in preterm infants at birth. Pediatrics. 2014 Jan;133(1):171-4. doi: 10.1542/peds.2013-3442. Epub 2013 Dec 30.
PubMed 24379228
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Comparing Surfactant Administration Through Supraglottic Airway or Thin Catheter for Preterm Infants
- ClinicalTrials.gov ID
- NCT07030270
- Acronym / sponsor ID
- SALTI / STU20250018
- Keywords
- preterm infants, surfactant therapy, respiratory distress syndrome
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 5 Aug 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 22 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.
What is this study about? This study is comparing two ways of giving surfactant, a medicine that helps premature infants breathe better. Surfactant can be given using a thin tube ("Less Invasive Surfactant Administration", called the LISA method) or through a small airway device placed in the baby's throat above the vocal cords ("Surfactant Administration through Laryngeal or Supraglottic Airway", called the SALSA method). The goal is to see which method is safer and more effective for preterm infants who are born at 29-36 weeks of pregnancy and have trouble breathing.
What is the main question (hypothesis)? Infants who receive surfactant using the SALSA method will have fewer heart rate and breathing-related problems than those who receive it using the LISA method.
What are the aims? Aim 1: Are babies in the SALSA group less likely to have low heart rate or low oxygen levels during the procedure compared to babies in the LISA group? Aim 2: Do fewer babies in the SALSA group need to be put on a breathing machine within the first 72 hours of life? Aim 3: Does the SALSA method help reduce the overall time babies need breathing support and lower the cost of their care in the NICU?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surfactant Administration through Laryngeal or Supraglottic Airway | Experimental | Procedure: Surfactant Administration through Laryngeal or Supraglottic Airway |
| Surfactant Administration through Thin Catheter | Active comparator | Procedure: Surfactant Administration through Thin Catheter |
Who may qualify
- Ages
- 0 to 72 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- All preterm infants born between 29-36 weeks' gestation.
- Infants with birthweight greater than or equal to 750 grams and admitted to the NICU on CPAP for respiratory support requiring at least FiO2 25% and qualify for LISA procedure
Key exclusion criteria (3 listed)
- Infants who require intubation prior to surfactant therapy
- Infants with known severe congenital anomalies (complex congenital heart disease, airway and central nervous system anomalies)
- Infants whose birth weight is less than 750 grams or oropharynx unable to accommodate laryngeal mask airways
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 |
|---|---|---|
| Surfactant Administration through Laryngeal or Supraglottic AirwaySurfactant Administration through Supraglottic Airway Devices -AerVia sizes S, M, L, XL | Procedure or surgery | Surfactant Administration through Laryngeal or Supraglottic Airway |
| Surfactant Administration through Thin CatheterThin Catheter | Procedure or surgery | Surfactant Administration through Thin Catheter |
Primary outcome
Combined bradycardia (heart rate < 100 for > 10 seconds) and hypoxemia (SpO2 < 80% for > 30 seconds) during surfactant administration
Time frame: Time of laryngoscope or supraglottic airway device insertion to removal of device
* Bradycardia: defined as heart rate < 100 beats per minute for > 10 seconds. Heart rate will be obtained from participant's heart rate monitor. * Hypoxemia: oxygen saturation (SpO2) =< 80% for > 30 seconds. Oxygen saturation will be obtained from participant's pulse oximeter monitor * Events will be recorded by bedside respiratory therapy and/or bedside nurse during the procedure
4 secondary outcomes
Procedural success rate on first attempt
Time frame: At time of surfactant administration procedure
Intubation rate
Time frame: From time of procedure to 72 hours of life
Mean number of attempts required
Time frame: At time of surfactant administration
Total duration of CPAP and mechanical ventilation days
Time frame: Up to 52 weeks
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 16 Sep 2026.
- Background: PubMed 32989046Roberts CT, Manley BJ, O'Shea JE, Stark M, Andersen C, Davis PG, Buckmaster A. Supraglottic airway devices for administration of surfactant to newborn infants with respiratory distress syndrome: a narrative review. Arch Dis Child Fetal Neonatal Ed. 2021 May;106(3):336-341. doi: 10.1136/archdischild-2020-319804. Epub 2020 Sep 28.
- Background: PubMed 29174079Roberts KD, Brown R, Lampland AL, Leone TA, Rudser KD, Finer NN, Rich WD, Merritt TA, Czynski AJ, Kessel JM, Tipnis SM, Stepka EC, Mammel MC. Laryngeal Mask Airway for Surfactant Administration in Neonates: A Randomized, Controlled Trial. J Pediatr. 2018 Feb;193:40-46.e1. doi: 10.1016/j.jpeds.2017.09.068. Epub 2017 Nov 22.
- Background: PubMed 36336195Wyckoff MH, Greif R, Morley PT, Ng KC, Olasveengen TM, Singletary EM, Soar J, Cheng A, Drennan IR, Liley HG, Scholefield BR, Smyth MA, Welsford M, Zideman DA, Acworth J, Aickin R, Andersen LW, Atkins D, Berry DC, Bhanji F, Bierens J, Borra V, Bottiger BW, Bradley RN, Bray JE, Breckwoldt J, Callaway CW, Carlson JN, Cassan P, Castren M, Chang WT, Charlton NP, Phil Chung S, Considine J, Costa-Nobre DT, Couper K, Couto TB, Dainty KN, Davis PG, de Almeida MF, de Caen AR, Deakin CD, Djarv T, Donnino MW, Douma MJ, Duff JP, Dunne CL, Eastwood K, El-Naggar W, Fabres JG, Fawke J, Finn J, Foglia EE, Folke F, Gilfoyle E, Goolsby CA, Granfeldt A, Guerguerian AM, Guinsburg R, Hirsch KG, Holmberg MJ, Hosono S, Hsieh MJ, Hsu CH, Ikeyama T, Isayama T, Johnson NJ, Kapadia VS, Kawakami MD, Kim HS, Kleinman M, Kloeck DA, Kudenchuk PJ, Lagina AT, Lauridsen KG, Lavonas EJ, Lee HC, Lin YJ, Lockey AS, Maconochie IK, Madar RJ, Malta Hansen C, Masterson S, Matsuyama T, McKinlay CJD, Meyran D, Morgan P, Morrison LJ, Nadkarni V, Nakwa FL, Nation KJ, Nehme Z, Nemeth M, Neumar RW, Nicholson T, Nikolaou N, Nishiyama C, Norii T, Nuthall GA, O'Neill BJ, Gene Ong YK, Orkin AM, Paiva EF, Parr MJ, Patocka C, Pellegrino JL, Perkins GD, Perlman JM, Rabi Y, Reis AG, Reynolds JC, Ristagno G, Rodriguez-Nunez A, Roehr CC, Rudiger M, Sakamoto T, Sandroni C, Sawyer TL, Schexnayder SM, Schmolzer GM, Schnaubelt S, Semeraro F, Skrifvars MB, Smith CM, Sugiura T, Tijssen JA, Trevisanuto D, Van de Voorde P, Wang TL, Weiner GM, Wyllie JP, Yang CW, Yeung J, Nolan JP, Berg KM; Collaborators. 2022 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations: Summary From the Basic Life Support; Advanced Life Support; Pediatric Life Support; Neonatal Life Support; Education, Implementation, and Teams; and First Aid Task Forces. Resuscitation. 2022 Dec;181:208-288. doi: 10.1016/j.resuscitation.2022.10.005. Epub 2022 Nov 3.
- Background: PubMed 35986148Kakkilaya V, Gautham KS. Should less invasive surfactant administration (LISA) become routine practice in US neonatal units? Pediatr Res. 2023 Apr;93(5):1188-1198. doi: 10.1038/s41390-022-02265-8. Epub 2022 Aug 19.
- Background: PubMed 30635595Kurepa D, Perveen S, Lipener Y, Kakkilaya V. The use of less invasive surfactant administration (LISA) in the United States with review of the literature. J Perinatol. 2019 Mar;39(3):426-432. doi: 10.1038/s41372-018-0302-9. Epub 2019 Jan 11.
- Background: PubMed 34552000Kakkilaya VB, Weydig HM, Smithhart WE, Renfro SD, Garcia KM, Brown CM, He H, Wagner SA, Metoyer GC, Brown LS, Kapadia VS, Savani RC, Jaleel MA. Decreasing Continuous Positive Airway Pressure Failure in Preterm Infants. Pediatrics. 2021 Oct;148(4):e2020014191. doi: 10.1542/peds.2020-014191. Epub 2021 Sep 22.
- Background: PubMed 24379228Committee on Fetus and Newborn; American Academy of Pediatrics. Respiratory support in preterm infants at birth. Pediatrics. 2014 Jan;133(1):171-4. doi: 10.1542/peds.2013-3442. Epub 2013 Dec 30.
- Individual participant dataSharing planned: No. Data will be collected and de-identified at the time of analysis. IPD availability does not to enhance study results.
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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.
Kathryn Mazioniene, R.N. contact
Melody Chiu, M.D. principal investigator
University of Texas Southwestern 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 Surfactant Administration through Laryngeal or Supraglottic Airway and Surfactant Administration through Thin Catheter in people with Surfactant and Respiratory Distress Syndrome (Neonatal), run by University of Texas Southwestern 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 2 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: looking for participants now, as of the sponsor's last update on 16 Sep 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?
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 Melody Chiu, M.D. (214-648-3903, melody.chiu@utsouthwestern.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Combined bradycardia (heart rate < 100 for > 10 seconds) and hypoxemia (SpO2 < 80% for > 30 seconds) during surfactant administration (time frame: Time of laryngoscope or supraglottic airway device insertion to removal of device). 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 NCT07030270, 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 16 Sep 2026.