PrematurityNCT04911452
Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants
A study testing Calmer in people with Prematurity, run by University of British Columbia at 1 site in Canada.
Trial summary
Infants born preterm can spend months in the neonatal intensive care unit (NICU) where they experience stressful but essential procedures. Untreated stress is associated with altered brain development. Read more about this study
- Who is it for?
- Ages 26 to 30 weeks
- Conditions the study is for
- Prematurity
- What is being tested?
- Calmer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- 27 Sep 2021to 31 Dec 2025
- 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 26 to 30 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Preterm infants admitted to the neonatal intensive care unit (NICU) at the British Columbia (BC) Women's Hospital born at 26-30 completed weeks gestational age (GA). GA is determined accurately using early gestation ultrasonogram (standard of care in BC), or calculated using the last menstrual period;
- Infants who are on continuous positive airway pressure or are ventilated;
- At least one parent/caregiver must speak sufficient English to provide consent
Who cannot join
- Infants who have congenital anomalies, small for GA (per medical admission history), or have a history of maternal abuse of controlled drugs and substances; - Infants with an ongoing infection at the time of enrolment;
- Infants that have pre-existing cardiovascular instability defined by shock/hypotension/need for cardiovascular drugs
- Infants receiving paralytic drugs;
- Infants that have major neurological injury (e.g. hypoxic ischemic encephalopathy, hemorrhage/stroke);
- Infants who are beyond the 30th completed week GA (30 weeks + 6 days) at enrolment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
British Columbia Women's Hospital and Health Centre
Vancouver, British Columbia, V6H 3N1
Manon Ranger, PhD, 1-604-827-1382, manon.ranger@ubc.ca
Naama Rozen, MSc, 1-604-875-2000 ext. 7408, Naama.Rozen@cw.bc.ca
About this study
Official title: Creating a CALMER NICU: Pilot Testing a Robot for Optimizing Growth and Brain Development in Preterm Infants in the NICU
Infants born preterm can spend months in the neonatal intensive care unit (NICU) where they experience stressful but essential procedures. Untreated stress is associated with altered brain development. Skin-to-skin care (SSC) is one of the most effective behavioral strategies for mitigating preterm infant stress and improving brain maturation. However, parents may not be always available to provide SSC; some infants cannot be held for long periods for medical reasons. To address this problem, investigators designed Calmer, a patented, prototype therapy bed, for reducing stress in preterm infants. Calmer fits into NICU incubators and provides simultaneously an artificial skin surface, heartbeat sounds and breathing motion, mimicking aspects of SSC; the latter 2 features are individualized for each infant based on their parents' recordings. The 1st randomized controlled trial (RCT) in 58 preterm babies showed that during a routine blood test: Calmer lowered infant behavioral and heart stress responses and stabilized brain blood flow no differently than facilitated tucking; infants could be cared for safely on Calmer up to 6 hours in 1 day; Calmer was well accepted by mothers and staff.
The goal now is to determine the efficacy of Calmer use over 3 weeks to support optimal physical growth and brain development in preterm infants. A 2-group (treatment, control) pilot RCT to test the implementation of an increased "dose" of Calmer exposure over 2-3 continuous weeks is proposed. 30 infants born between 26-30 weeks gestational age in the NICU will be randomized to receive either Calmer, for a minimum of 3 hours in total/day for 2-3 continuous weeks, or to 2-3 weeks of standard NICU care (minimum of 2 and maximum of 3 weeks).
Read more
Research questions:
Trial feasibility Q1. Is it feasible to enrol 30 infants, complete a 2-3-week treatment period (minimum of 2 and maximum of 3 weeks), and measure growth outcomes in preterm infants (26-30 weeks GA) in the NICU in a pilot RCT of daily Calmer treatment versus standard NICU care to inform a larger, definitive RCT?
Infant outcomes Q2a. Are there differences in physical growth markers (daily weight gain, head circumference, body length) between preterm infants who receive Calmer and those who receive standard NICU care measured before (baseline) and after 2-3 weeks of daily Calmer exposure? Q2b. Are there differences in brain activity markers, as measured by cerebral electrical (EEG) signalling, between preterm infants who receive Calmer and those who receive standard NICU care, measured during a resting/sleeping state and routine diaper change session at the end of the trial (post 2-3 weeks of daily Calmer exposure)?
Read the detailed description
Pilot trial implementation targets:
Targets for success would be that the informed consent rate will be at least 40%, 30 patients will be enrolled in 48 months, 95% of infants will receive the 3 hour minimum treatment, and patient assessment completion rate will be at least 85%.
The results of this pilot trial will be used to inform the design of a larger RCT. The results of this pilot trial will allow to assess patient accrual, protocol adherence, and to monitor the completeness and quality of the outcome data. If implementation targets are met, an application for further funding to use this protocol in a larger, multisite, non-inferiority trial comparing SSC + Calmer to SSC alone will be put forth.
- Conditions
- Prematurity
- Being tested
- Calmer
- Keywords
- Prematurity, Neonatal intensive care, Growth, Robotic device, Skin-to-skin care, Stress, Brain activity, EEG
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CalmerDevice
Once randomized, infants in the Calmer group will receive treatment for a minimum cumulative total of 3 hours/day during periods when the infant may be too ill to be held or when parents do not wish to hold their infant or are not present. Calmer does not replicate a parent's contact and so the minimum exposure has been tripled. No upper limit of Calmer use will be set. Each day, the research and/or bedside nurse will record the heart and respiratory rates for a two-minute period. The one-minute average will be used to program Calmer for each infant that day to better simulate day-to-day changes in infant-parent contact. The Neonatal Intensive Care Unit (NICU) research nurse will also train the parents/caregivers to self-measure their resting heart and breathing rates so that if they are away from the NICU for more than one day, these values can be sent to the research/ bedside nurse by phone.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard Neonatal Intensive Care Unit (NICU) care |
| Calmer | Experimental | Calmer placed and left in infant incubator for a minimum of 2 and maximum of 3 weeks.
Calmer treatment provided for minimum total of 3 hours/day (can be discontinuous). Receives: Device: Calmer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trial feasibility: Consent rates
Overall average consent rate of infants/month
Measured: 48 months
Trial feasibility: Protocol delivery rate
Percent of on/off protocol infants for the trial period
Measured: 48 months
Trial feasibility: Complete outcome measures
Percent of infants with complete clinical primary and secondary outcome measures
Measured: 48 months
Trial feasibility: Safety issues
Rate of safety issues identified
Measured: 48 months
Secondary outcomes (5)
Brain activity at rest and during stress event (routine diaper change)
EEG measure during a single session (at end of the 3-week). EEG assessments for ~60 min when the infants are at rest in their incubator (undisturbed during quiet/active sleep) while laying on the Calmer device turned off (if experimental group, otherwise incubator as standard).
EEG measurements will be taken in 4 phases:
- Baseline A: 15-minute Sleep + Calmer device OFF (Pre)
- Baseline B: 15-minute Sleep + Calmer device ON
- Stressful event: Diaper change (standardized) + Calmer device ON
- Recovery: 15-minute Sleep + Calmer device ON
We will conduct brain activity EEG measurements using a 64-channel HydroCel Geodesic Sensor Net specifically designed to suit the very small heads and fragile skin of preterm infants (EGI, Eugene, OR). We will have synchronized bedside video recordings and code stress behaviours using the NICU standard pain assessment tool.
Measured: 2-3 weeks
Weight gain
The change in average infant weight gain between Calmer and control groups in grams/day (g/d) will be measured on the day before the start of the treatment (baseline), at the mid-way point (~day 11), and at the end of the 3-week period, then divided by the number of treatment days. Sex and gestational age (GA) age-specific percentiles for the measures will be calculated using the Fenton Growth charts. Changes in weight percentiles between baseline and end of treatment will then be calculated.
Measured: 2-3 weeks
Nutritional status
Measures of daily feeding and nutritional data will include: method of feeding (intravenous, nasogastric, oral-gastric, oral), type (total parenteral nutrition, breastmilk (mother's or donor), formula, additives (Human milk fortifier, lipids), frequency/timing and method (breast/bottle) of transition from tube to oral feeds at transfer/discharge.
Measured: 2-3 weeks
Head circumference
Baseline, mid-point and end-of-treatment measures of head circumference in cm (occipito-frontal circumference [OCP]) will be reported. Sex and GA age-specific percentiles for the measures will be calculated using the Fenton Growth charts. Changes in OFC percentiles between baseline and end of treatment will then be calculated.
Measured: 2-3 weeks
Body length
Baseline, mid-point and end-of-treatment measures of body length in cm will be reported. Sex and GA age-specific percentiles for the measures will be calculated using the Fenton Growth charts. Changes in body length percentiles between baseline and end of treatment wil then be calculated.
Measured: 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2021
- Study start27 Sep 2021
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Model description
- Single-site, single-blind, two-group (treatment and control), randomized pilot trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Women's Health Research Institute of British Columbia
- Responsible party
- Principal investigator, Manon Ranger, University of British Columbia
- Investigators
- Liisa Holsti, PhD, Principal investigator, The University of British ColumbiaManon Ranger, PhD, Principal investigator, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04911452
- Sponsor's protocol ID
- H21-00527
- Status last verified
- Dec 2024
- First submitted
- 22 May 2021
- Last updated
- 1 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Johnston C, Campbell-Yeo M, Disher T, Benoit B, Fernandes A, Streiner D, Inglis D, Zee R. Skin-to-skin care for procedural pain in neonates. Cochrane Database Syst Rev. 2017 Feb 16;2(2):CD008435. doi: 10.1002/14651858.CD008435.pub3.
PubMed 28205208Holsti L, MacLean K, Oberlander T, Synnes A, Brant R. Calmer: a robot for managing acute pain effectively in preterm infants in the neonatal intensive care unit. Pain Rep. 2019 Mar 14;4(2):e727. doi: 10.1097/PR9.0000000000000727. eCollection 2019 Mar-Apr.
PubMed 31041426Ranger M, Albert A, MacLean K, Holsti L. Cerebral hemodynamic response to a therapeutic bed for procedural pain management in preterm infants in the NICU: a randomized controlled trial. Pain Rep. 2021 Jan 12;6(1):e890. doi: 10.1097/PR9.0000000000000890. eCollection 2021 Jan-Feb.
PubMed 33490850Williams N, MacLean K, Guan L, Collet JP, Holsti L. Pilot Testing a Robot for Reducing Pain in Hospitalized Preterm Infants. OTJR (Thorofare N J). 2019 Apr;39(2):108-115. doi: 10.1177/1539449218825436. Epub 2019 Feb 15.
PubMed 30770034Fenton TR, Kim JH. A systematic review and meta-analysis to revise the Fenton growth chart for preterm infants. BMC Pediatr. 2013 Apr 20;13:59. doi: 10.1186/1471-2431-13-59.
PubMed 23601190Hauser S, Suto MJ, Holsti L, Ranger M, MacLean KE. Designing and Evaluating Calmer, a Device for Simulating Maternal Skin-to-Skin Holding for Premature Infants. In Proceedings of the 2020 CHI Conference on Human Factors in Computing Systems (CHI '20). 2020. Association for Computing Machinery, New York, NY, USA: 1-15. https://doi.org/10.1145/3313831.3376539
Study at a glance
From the registry record, last updated by the sponsor on 1 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating a CALMER NICU: Pilot Testing a Robot for Optimizing Growth and Brain Development in Preterm Infants in the NICU
- ClinicalTrials.gov ID
- NCT04911452
- Acronym / sponsor ID
- H21-00527
- Conditions
- Prematurity
- Keywords
- Prematurity, Neonatal intensive care, Growth, Robotic device, Skin-to-skin care, Stress, Brain activity, EEG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Women's Health Research Institute of British Columbia
- Study start
- 27 Sep 2021 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 3 Jun 2021 (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.
Infants born preterm can spend months in the neonatal intensive care unit (NICU) where they experience stressful but essential procedures. Untreated stress is associated with altered brain development. Skin-to-skin care (SSC) is one of the most effective behavioral strategies for mitigating preterm infant stress and improving brain maturation. However, parents may not be always available to provide SSC; some infants cannot be held for long periods for medical reasons. To address this problem, investigators designed Calmer, a patented, prototype therapy bed, for reducing stress in preterm infants. Calmer fits into NICU incubators and provides simultaneously an artificial skin surface, heartbeat sounds and breathing motion, mimicking aspects of SSC; the latter 2 features are individualized for each infant based on their parents' recordings. The 1st randomized controlled trial (RCT) in 58 preterm babies showed that during a routine blood test: Calmer lowered infant behavioral and heart stress responses and stabilized brain blood flow no differently than facilitated tucking; infants could be cared for safely on Calmer up to 6 hours in 1 day; Calmer was well accepted by mothers and staff.
The goal now is to determine the efficacy of Calmer use over 3 weeks to support optimal physical growth and brain development in preterm infants. A 2-group (treatment, control) pilot RCT to test the implementation of an increased "dose" of Calmer exposure over 2-3 continuous weeks is proposed. 30 infants born between 26-30 weeks gestational age in the NICU will be randomized to receive either Calmer, for a minimum of 3 hours in total/day for 2-3 continuous weeks, or to 2-3 weeks of standard NICU care (minimum of 2 and maximum of 3 weeks).
Research questions:
Trial feasibility Q1. Is it feasible to enrol 30 infants, complete a 2-3-week treatment period (minimum of 2 and maximum of 3 weeks), and measure growth outcomes in preterm infants (26-30 weeks GA) in the NICU in a pilot RCT of daily Calmer treatment versus standard NICU care to inform a larger, definitive RCT?
Infant outcomes Q2a. Are there differences in physical growth markers (daily weight gain, head circumference, body length) between preterm infants who receive Calmer and those who receive standard NICU care measured before (baseline) and after 2-3 weeks of daily Calmer exposure? Q2b. Are there differences in brain activity markers, as measured by cerebral electrical (EEG) signalling, between preterm infants who receive Calmer and those who receive standard NICU care, measured during a resting/sleeping state and routine diaper change session at the end of the trial (post 2-3 weeks of daily Calmer exposure)?
Detailed description
Pilot trial implementation targets:
Targets for success would be that the informed consent rate will be at least 40%, 30 patients will be enrolled in 48 months, 95% of infants will receive the 3 hour minimum treatment, and patient assessment completion rate will be at least 85%.
The results of this pilot trial will be used to inform the design of a larger RCT. The results of this pilot trial will allow to assess patient accrual, protocol adherence, and to monitor the completeness and quality of the outcome data. If implementation targets are met, an application for further funding to use this protocol in a larger, multisite, non-inferiority trial comparing SSC + Calmer to SSC alone will be put forth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Single-site, single-blind, two-group (treatment and control), randomized pilot trial
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard Neonatal Intensive Care Unit (NICU) care |
| Calmer | Experimental | Device: CalmerCalmer placed and left in infant incubator for a minimum of 2 and maximum of 3 weeks. Calmer treatment provided for minimum total of 3 hours/day (can be discontinuous). |
Who may qualify
- Ages
- 26 to 30 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Preterm infants admitted to the neonatal intensive care unit (NICU) at the British Columbia (BC) Women's Hospital born at 26-30 completed weeks gestational age (GA). GA is determined accurately using early gestation ultrasonogram (standard of care in BC), or calculated using the last menstrual period;
- Infants who are on continuous positive airway pressure or are ventilated;
- At least one parent/caregiver must speak sufficient English to provide consent
Key exclusion criteria (5 listed)
- Infants who have congenital anomalies, small for GA (per medical admission history), or have a history of maternal abuse of controlled drugs and substances; - Infants with an ongoing infection at the time of enrolment;
- Infants that have pre-existing cardiovascular instability defined by shock/hypotension/need for cardiovascular drugs
- Infants receiving paralytic drugs;
- Infants that have major neurological injury (e.g. hypoxic ischemic encephalopathy, hemorrhage/stroke);
- Infants who are beyond the 30th completed week GA (30 weeks + 6 days) at enrolment.
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 |
|---|---|---|
| CalmerOnce randomized, infants in the Calmer group will receive treatment for a minimum cumulative total of 3 hours/day during periods when the infant may be too ill to be held or when parents do not wish to hold their infant or are not present. Calmer does not replicate a parent's contact and so the minimum exposure has been tripled. No upper limit of Calmer use will be set. Each day, the research and/or bedside nurse will record the heart and respiratory rates for a two-minute period. The one-minute average will be used to program Calmer for each infant that day to better simulate day-to-day changes in infant-parent contact. The Neonatal Intensive Care Unit (NICU) research nurse will also train the parents/caregivers to self-measure their resting heart and breathing rates so that if they are away from the NICU for more than one day, these values can be sent to the research/ bedside nurse by phone. | Device | Calmer |
Primary outcome
Trial feasibility: Consent rates
Time frame: 48 months
Overall average consent rate of infants/month
Trial feasibility: Protocol delivery rate
Time frame: 48 months
Percent of on/off protocol infants for the trial period
Trial feasibility: Complete outcome measures
Time frame: 48 months
Percent of infants with complete clinical primary and secondary outcome measures
Trial feasibility: Safety issues
Time frame: 48 months
Rate of safety issues identified
5 secondary outcomes
Brain activity at rest and during stress event (routine diaper change)
Time frame: 2-3 weeks
Weight gain
Time frame: 2-3 weeks
Nutritional status
Time frame: 2-3 weeks
Head circumference
Time frame: 2-3 weeks
Body length
Time frame: 2-3 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 1 Jan 2025.
- Background: PubMed 28205208Johnston C, Campbell-Yeo M, Disher T, Benoit B, Fernandes A, Streiner D, Inglis D, Zee R. Skin-to-skin care for procedural pain in neonates. Cochrane Database Syst Rev. 2017 Feb 16;2(2):CD008435. doi: 10.1002/14651858.CD008435.pub3.
- Background: PubMed 31041426Holsti L, MacLean K, Oberlander T, Synnes A, Brant R. Calmer: a robot for managing acute pain effectively in preterm infants in the neonatal intensive care unit. Pain Rep. 2019 Mar 14;4(2):e727. doi: 10.1097/PR9.0000000000000727. eCollection 2019 Mar-Apr.
- Background: PubMed 33490850Ranger M, Albert A, MacLean K, Holsti L. Cerebral hemodynamic response to a therapeutic bed for procedural pain management in preterm infants in the NICU: a randomized controlled trial. Pain Rep. 2021 Jan 12;6(1):e890. doi: 10.1097/PR9.0000000000000890. eCollection 2021 Jan-Feb.
- Background: PubMed 30770034Williams N, MacLean K, Guan L, Collet JP, Holsti L. Pilot Testing a Robot for Reducing Pain in Hospitalized Preterm Infants. OTJR (Thorofare N J). 2019 Apr;39(2):108-115. doi: 10.1177/1539449218825436. Epub 2019 Feb 15.
- Background: PubMed 23601190Fenton TR, Kim JH. A systematic review and meta-analysis to revise the Fenton growth chart for preterm infants. BMC Pediatr. 2013 Apr 20;13:59. doi: 10.1186/1471-2431-13-59.
- BackgroundHauser S, Suto MJ, Holsti L, Ranger M, MacLean KE. Designing and Evaluating Calmer, a Device for Simulating Maternal Skin-to-Skin Holding for Premature Infants. In Proceedings of the 2020 CHI Conference on Human Factors in Computing Systems (CHI '20). 2020. Association for Computing Machinery, New York, NY, USA: 1-15. https://doi.org/10.1145/3313831.3376539
- 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.
Liisa Holsti, PhD principal investigator
The University of British Columbia
Manon Ranger, PhD principal investigator
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calmer in people with Prematurity, run by University of British Columbia at 1 site in Canada.
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 5 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 1 Jan 2025. 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 Canada. 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 Manon Ranger, PhD (1-604-827-1382, manon.ranger@ubc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trial feasibility: Consent rates (time frame: 48 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04911452, which also lists 6 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 1 Jan 2025.