Newborn HypothermiaNCT06000826
Efficacy of Celsi Warmer for the Management of Hypothermic Newborns
A study testing Celsi Warmer in people with Newborn Hypothermia, run by William Marsh Rice University at 1 site in Tanzania.
Trial summary
The purpose of the study is to evaluate the efficacy of a novel low-cost warming device to provide thermal care for newborn babies with hypothermia in low-resource hospitals. During the study, research participants will receive thermal care via the Celsi Warmer. Read more about this study
- Who is it for?
- Ages 0 to 28 days
- Conditions the study is for
- Newborn Hypothermia
- What is being tested?
- Celsi Warmer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTanzania
- Study dates
- 27 Sep 2022to 20 Aug 2024
- 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 0 to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Is currently being treated at study location
- Is an inborn admission to the neonatal ward
- Whose parents or guardians provided a written informed consent
- Whose parents or guardians providing informed consent are 18 years old or older
- Has a current weight of greater than or equal to 1.0 kg and less than or equal to 4.0kg
- Has been identified as in need of thermal care defined as having a moderate hypothermic temperature (32.0-36.0°C) as the last temperature recorded in hospital chart, or during recruitment procedures; and
Show all 12Show fewer
- Is unable to be enrolled in KMC for reasons including, but not limited to:
- Mother/guardian unable or unavailable to provide KMC
- Under observation in NICU before transfer to KMC
- No space in KMC
- Clinician's discretion
- May be receiving other medical treatments, including but not limited to, CPAP, oxygen therapy, IV fluids, management and monitoring of common newborn conditions such as hypoglycemia, and/or hyperbilirubinemia via LED phototherapy
Who cannot join
- Requires mechanical ventilation
- deemed in need of intensive care by the hospital staff who is providing care,including but not limited to:
- Neonates with severe anemia and/or any suspected hematological disorders, and/or
- Neonates with obvious congenital anomalies, and/or
- neonates suspected with hypo/hyperthyroidism or any hormonal disorders
- Has been diagnosed with birth asphyxia
Show all 9Show fewer
- Presents a condition that precludes the use of the temperature sensor and/or abdominal belt including but not limited to, gastroschisis, known umbilical cord infection, known skin infection
- Whose clinician presents concerns about their participation
- Is receiving treatment that participation in the study would interfere with, i.e.transferring to KMC
Trial locations and contacts
1 site in 1 country.
Natalie Mitchell contact
Tanzania1 site, 1 recruiting
- Recruiting
Muhimbili University of Health and Allied Sciences (MUHAS)
Dar es Salaam
Nahya Salim, MMED, +255 713 250074, nsalim@ihi.or.tz
Robert Moshiro, MMED, +255 713 35, moshiror@gmail.com
About this study
Official title: Efficacy of a Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns
The purpose of the study is to evaluate the efficacy of a novel low-cost warming device to provide thermal care for newborn babies with hypothermia in low-resource hospitals. During the study, research participants will receive thermal care via the Celsi Warmer. Aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. The results from this study will allow us to determine if the Celsi Warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. The research team hopes to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings.
- Conditions
- Newborn Hypothermia
- Being tested
- Celsi Warmer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Celsi WarmerDevice
During the study, research participants will receive thermal care via the Celsi Warmer. Aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. The results from this study will allow the research team to determine if the Celsi Warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. The research team hopes to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings.
| Study group | Role | What they receive |
|---|---|---|
| Neonatal | Experimental | * A trained study nurse or clinician will transfer the enrolled participant to the study location and place the infant on the Celsi Warmer mattress.
* A trained study nurse or clinician will attach the Celsi Warmer temperature sensor to the abdomen and secure it with the abdominal belt according to the device's instruction manual
* A trained study nurse or clinician will wrap the baby according to the standard care at the hospital.
* Study personnel may observe the participant during the intervention period and annotate timestamped events that might affect temperature measurement and/or thermoregulation support intervention.
* Study personnel will perform routine abdominal skin assessments as often as every two hours and at least every 8 hours to observe for skin irritation or indentation.
* Thermoregulation support intervention will be provided as long as the infant continues to meet criteria for continued care at clinician's discretion. Receives: Device: Celsi Warmer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Broad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns
To evaluate the clinical efficacy and safety of the Celsi Warmer in rewarming hypothermic newborns by comparing the Celsi Warmer's accuracy in measuring neonatal temperature compared to the gold standard, axillary temperature readings.
Measured: 1 year
Secondary outcomes (5)
Efficacy of the Device
To assess the performance of the Celsi Warmer in rewarming hypothermic newborns by measuring the incidence of attainment of normothermia (36.5-37.5°C)
Measured: 1 year
Safety of the Device - Measure of Infant's Increase in Temperature
To measure the infant's rate of temperature (°C) increase through thermoregulatory intervention.
Measured: 1 year
Safety of the Device - Local Effect of the Abdominal Belt
To evaluate the local effect of the abdominal belt on newborn's skin by looking at any evidence of skin irritation
Measured: 1 year
Safety of the Device - Incidence of Hyperthermia
To evaluate any incidence of hyperthermia (>37.5°C) during the thermoregulation intervention.
Measured: 1 year
Safety of the Device - Incidence of Rebound Hypothermia
To report any incidence of rebound hypothermia ( < 36.5°C) (post-intervention hypothermia) up to 72 hours from the initial encounter.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start27 Sep 2022
- Primary completion20 Aug 2024 (estimated)
- Study completion20 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Newborn HypothermiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- William Marsh Rice University
- Sponsor type
- University, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Responsible party
- Sponsor
- Investigators
- Rebecca R Richards-Kortum, PhD, Principal investigator, William Marsh Rice University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000826
- Sponsor's protocol ID
- 2022-271
- Status last verified
- Aug 2023
- First submitted
- 31 May 2023
- Last updated
- 22 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kumar V, Shearer JC, Kumar A, Darmstadt GL. Neonatal hypothermia in low resource settings: a review. J Perinatol. 2009 Jun;29(6):401-12. doi: 10.1038/jp.2008.233. Epub 2009 Jan 22.
PubMed 19158799Carns J, Kawaza K, Quinn MK, Miao Y, Guerra R, Molyneux E, Oden M, Richards-Kortum R. Impact of hypothermia on implementation of CPAP for neonatal respiratory distress syndrome in a low-resource setting. PLoS One. 2018 Mar 15;13(3):e0194144. doi: 10.1371/journal.pone.0194144. eCollection 2018.
PubMed 29543861Cavallin F, Calgaro S, Brugnolaro V, Seni AHA, Muhelo AR, Da Dalt L, Putoto G, Trevisanuto D. Impact of temperature change from admission to day one on neonatal mortality in a low-resource setting. BMC Pregnancy Childbirth. 2020 Oct 23;20(1):646. doi: 10.1186/s12884-020-03343-7.
PubMed 33097025Mullany LC. Neonatal hypothermia in low-resource settings. Semin Perinatol. 2010 Dec;34(6):426-33. doi: 10.1053/j.semperi.2010.09.007.
PubMed 21094417Lunze K, Bloom DE, Jamison DT, Hamer DH. The global burden of neonatal hypothermia: systematic review of a major challenge for newborn survival. BMC Med. 2013 Jan 31;11:24. doi: 10.1186/1741-7015-11-24.
PubMed 23369256Manji KP, Kisenge R. Neonatal hypothermia on admission to a special care unit in Dar-es-Salaam, Tanzania: a cause for concern. Cent Afr J Med. 2003 Mar-Apr;49(3-4):23-7.
PubMed 14562586Laptook AR, Salhab W, Bhaskar B; Neonatal Research Network. Admission temperature of low birth weight infants: predictors and associated morbidities. Pediatrics. 2007 Mar;119(3):e643-9. doi: 10.1542/peds.2006-0943. Epub 2007 Feb 12.
PubMed 17296783Lunze K, Hamer DH. Thermal protection of the newborn in resource-limited environments. J Perinatol. 2012 May;32(5):317-24. doi: 10.1038/jp.2012.11. Epub 2012 Mar 1.
PubMed 22382859de Almeida MF, Guinsburg R, Sancho GA, Rosa IR, Lamy ZC, Martinez FE, da Silva RP, Ferrari LS, de Souza Rugolo LM, Abdallah VO, Silveira Rde C; Brazilian Network on Neonatal Research. Hypothermia and early neonatal mortality in preterm infants. J Pediatr. 2014 Feb;164(2):271-5.e1. doi: 10.1016/j.jpeds.2013.09.049. Epub 2013 Nov 6.
PubMed 24210925ADAMSON SK Jr, TOWELL ME. THERMAL HOMEOSTASIS IN THE FETUS AND NEWBORN. Anesthesiology. 1965 Jul-Aug;26:531-48. doi: 10.1097/00000542-196507000-00017. No abstract available.
PubMed 14313463Nahimana E, May L, Gadgil A, Rapp V, Magge H, Kubwimana M, Nshimyiryo A, Kateera F, Feldman HA, Nkikabahizi F, Sayinzoga F, Hansen A. A low cost, re-usable electricity-free infant warmer: evaluation of safety, effectiveness and feasibiliy. Public Health Action. 2018 Dec 21;8(4):211-217. doi: 10.5588/pha.18.0031.
PubMed 30775282Wyllie J, Perlman JM, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation. 2015 Oct;95:e169-201. doi: 10.1016/j.resuscitation.2015.07.045. Epub 2015 Oct 15. No abstract available.
PubMed 26477424Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres J, Fawke J, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kim HS, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Rabi Y, Roehr CC, Schmolzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM; Neonatal Life Support Collaborators. Neonatal Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2020 Oct 20;142(16_suppl_1):S185-S221. doi: 10.1161/CIR.0000000000000895. Epub 2020 Oct 21.
PubMed 33084392WHO Immediate KMC Study Group; Arya S, Naburi H, Kawaza K, Newton S, Anyabolu CH, Bergman N, Rao SPN, Mittal P, Assenga E, Gadama L, Larsen-Reindorf R, Kuti O, Linner A, Yoshida S, Chopra N, Ngarina M, Msusa AT, Boakye-Yiadom A, Kuti BP, Morgan B, Minckas N, Suri J, Moshiro R, Samuel V, Wireko-Brobby N, Rettedal S, Jaiswal HV, Sankar MJ, Nyanor I, Tiwary H, Anand P, Manu AA, Nagpal K, Ansong D, Saini I, Aggarwal KC, Wadhwa N, Bahl R, Westrup B, Adejuyigbe EA, Plange-Rhule G, Dube Q, Chellani H, Massawe A. Immediate "Kangaroo Mother Care" and Survival of Infants with Low Birth Weight. N Engl J Med. 2021 May 27;384(21):2028-2038. doi: 10.1056/NEJMoa2026486.
PubMed 34038632Ahmed S, Mitra SN, Chowdhury AM, Camacho LL, Winikoff B, Sloan NL. Community Kangaroo Mother Care: implementation and potential for neonatal survival and health in very low-income settings. J Perinatol. 2011 May;31(5):361-7. doi: 10.1038/jp.2010.131. Epub 2011 Feb 10.
PubMed 21311502
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Low-cost Warming Mattress Celsi Warmer for the Management of Hypothermic Newborns
- ClinicalTrials.gov ID
- NCT06000826
- Acronym / sponsor ID
- 2022-271
- Conditions
- Newborn Hypothermia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- William Marsh Rice UniversityUniversity, hospital or other
- Collaborators
- Muhimbili University of Health and Allied Sciences
- Study start
- 27 Sep 2022 (actual)
- Primary completion
- 20 Aug 2024 (estimated)
- Study completion
- 20 Aug 2024 (estimated)
- First posted
- 21 Aug 2023 (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 purpose of the study is to evaluate the efficacy of a novel low-cost warming device to provide thermal care for newborn babies with hypothermia in low-resource hospitals. During the study, research participants will receive thermal care via the Celsi Warmer. Aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. The results from this study will allow us to determine if the Celsi Warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. The research team hopes to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neonatal | Experimental | Device: Celsi Warmer* A trained study nurse or clinician will transfer the enrolled participant to the study location and place the infant on the Celsi Warmer mattress. * A trained study nurse or clinician will attach the Celsi Warmer temperature sensor to the abdomen and secure it with the abdominal belt according to the device's instruction manual * A trained study nurse or clinician will wrap the baby according to the standard care at the hospital. * Study personnel may observe the participant during the intervention period and annotate timestamped events that might affect temperature measurement and/or thermoregulation support intervention. * Study personnel will perform routine abdominal skin assessments as often as every two hours and at least every 8 hours to observe for skin irritation or indentation. * Thermoregulation support intervention will be provided as long as the infant continues to meet criteria for continued care at clinician's discretion. |
Who may qualify
- Ages
- 0 to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (12 listed)
- Is currently being treated at study location
- Is an inborn admission to the neonatal ward
- Whose parents or guardians provided a written informed consent
- Whose parents or guardians providing informed consent are 18 years old or older
- Has a current weight of greater than or equal to 1.0 kg and less than or equal to 4.0kg
Key exclusion criteria (9 listed)
- Requires mechanical ventilation
- deemed in need of intensive care by the hospital staff who is providing care,including but not limited to:
- Has been diagnosed with birth asphyxia
- Presents a condition that precludes the use of the temperature sensor and/or abdominal belt including but not limited to, gastroschisis, known umbilical cord infection, known skin infection
- Whose clinician presents concerns about their participation
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 |
|---|---|---|
| Celsi WarmerDuring the study, research participants will receive thermal care via the Celsi Warmer. Aside from thermal treatment, research participants will receive the standard of care from the neonatal unit, and will also be closely monitored by study personnel throughout the study. The results from this study will allow the research team to determine if the Celsi Warmer is an effective tool for warming and monitoring newborns in wards of low-resource hospitals. The research team hopes to demonstrate that the Celsi Warmer is effective for the appropriate treatment of newborn hypothermia in hospitals in low-resource settings. | Device | Neonatal |
Primary outcome
Broad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns
Time frame: 1 year
To evaluate the clinical efficacy and safety of the Celsi Warmer in rewarming hypothermic newborns by comparing the Celsi Warmer's accuracy in measuring neonatal temperature compared to the gold standard, axillary temperature readings.
5 secondary outcomes
Efficacy of the Device
Time frame: 1 year
Safety of the Device - Measure of Infant's Increase in Temperature
Time frame: 1 year
Safety of the Device - Local Effect of the Abdominal Belt
Time frame: 1 year
Safety of the Device - Incidence of Hyperthermia
Time frame: 1 year
Safety of the Device - Incidence of Rebound Hypothermia
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Background: PubMed 19158799Kumar V, Shearer JC, Kumar A, Darmstadt GL. Neonatal hypothermia in low resource settings: a review. J Perinatol. 2009 Jun;29(6):401-12. doi: 10.1038/jp.2008.233. Epub 2009 Jan 22.
- Background: PubMed 29543861Carns J, Kawaza K, Quinn MK, Miao Y, Guerra R, Molyneux E, Oden M, Richards-Kortum R. Impact of hypothermia on implementation of CPAP for neonatal respiratory distress syndrome in a low-resource setting. PLoS One. 2018 Mar 15;13(3):e0194144. doi: 10.1371/journal.pone.0194144. eCollection 2018.
- Background: PubMed 33097025Cavallin F, Calgaro S, Brugnolaro V, Seni AHA, Muhelo AR, Da Dalt L, Putoto G, Trevisanuto D. Impact of temperature change from admission to day one on neonatal mortality in a low-resource setting. BMC Pregnancy Childbirth. 2020 Oct 23;20(1):646. doi: 10.1186/s12884-020-03343-7.
- Background: PubMed 21094417Mullany LC. Neonatal hypothermia in low-resource settings. Semin Perinatol. 2010 Dec;34(6):426-33. doi: 10.1053/j.semperi.2010.09.007.
- Background: PubMed 23369256Lunze K, Bloom DE, Jamison DT, Hamer DH. The global burden of neonatal hypothermia: systematic review of a major challenge for newborn survival. BMC Med. 2013 Jan 31;11:24. doi: 10.1186/1741-7015-11-24.
- Background: PubMed 14562586Manji KP, Kisenge R. Neonatal hypothermia on admission to a special care unit in Dar-es-Salaam, Tanzania: a cause for concern. Cent Afr J Med. 2003 Mar-Apr;49(3-4):23-7.
- Background: PubMed 17296783Laptook AR, Salhab W, Bhaskar B; Neonatal Research Network. Admission temperature of low birth weight infants: predictors and associated morbidities. Pediatrics. 2007 Mar;119(3):e643-9. doi: 10.1542/peds.2006-0943. Epub 2007 Feb 12.
- Background: PubMed 22382859Lunze K, Hamer DH. Thermal protection of the newborn in resource-limited environments. J Perinatol. 2012 May;32(5):317-24. doi: 10.1038/jp.2012.11. Epub 2012 Mar 1.
- Background: PubMed 24210925de Almeida MF, Guinsburg R, Sancho GA, Rosa IR, Lamy ZC, Martinez FE, da Silva RP, Ferrari LS, de Souza Rugolo LM, Abdallah VO, Silveira Rde C; Brazilian Network on Neonatal Research. Hypothermia and early neonatal mortality in preterm infants. J Pediatr. 2014 Feb;164(2):271-5.e1. doi: 10.1016/j.jpeds.2013.09.049. Epub 2013 Nov 6.
- Background: PubMed 14313463ADAMSON SK Jr, TOWELL ME. THERMAL HOMEOSTASIS IN THE FETUS AND NEWBORN. Anesthesiology. 1965 Jul-Aug;26:531-48. doi: 10.1097/00000542-196507000-00017. No abstract available.
- Background: PubMed 30775282Nahimana E, May L, Gadgil A, Rapp V, Magge H, Kubwimana M, Nshimyiryo A, Kateera F, Feldman HA, Nkikabahizi F, Sayinzoga F, Hansen A. A low cost, re-usable electricity-free infant warmer: evaluation of safety, effectiveness and feasibiliy. Public Health Action. 2018 Dec 21;8(4):211-217. doi: 10.5588/pha.18.0031.
- Background: PubMed 26477424Wyllie J, Perlman JM, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation. 2015 Oct;95:e169-201. doi: 10.1016/j.resuscitation.2015.07.045. Epub 2015 Oct 15. No abstract available.
- Individual participant dataSharing planned: No
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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.
Natalie Mitchell contact
Rebecca R Richards-Kortum, PhD principal investigator
William Marsh Rice University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Celsi Warmer in people with Newborn Hypothermia, run by William Marsh Rice University at 1 site in Tanzania.
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 12 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 22 Aug 2023. 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 Tanzania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sonia Sosa Saenz, BME (713-348-4963, ss171@rice.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Broad Objective - Comparison to the Gold Standard of Rewarming Hypothermic Newborns (time frame: 1 year). 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 NCT06000826, which also lists 24 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 22 Aug 2023.