Hyperbilirubinemia, Neonatal IndirectUDCA-NeoNCT07110987
The Efficacy of Ursodeoxycholic Acid (UDCA) as Adjuvant Therapy to Phototherapy in the Management of Neonatal Indirect Hyperbilirubinemia
A study testing Phototherapy and ursodeoxycholic acid (UDCA) in people with Hyperbilirubinemia, Neonatal Indirect, run by Tishreen University Hospital at 1 site in Syria.
Trial summary
This is a prospective, open-label, randomized controlled trial conducted at Lattakia University Hospital (Tishreen University), aiming to evaluate the efficacy of Ursodeoxycholic Acid (UDCA) as an adjuvant to triple phototherapy in the management of indirect hyperbilirubinemia in neonates ≥34 weeks of gestation. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Hyperbilirubinemia, Neonatal Indirect
- What is being tested?
- Phototherapy and ursodeoxycholic acid (UDCA)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteSyria
- Study dates
- 26 Jun 2025to 1 Mar 2027
- 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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Neonates with gestational age ≥ 34 weeks
- Appropriate for Gestational Age (AGA) infants
- Presence of indirect hyperbilirubinemia that meets the threshold for phototherapy.
Who cannot join
- Gestational age < 34 weeks
- Small or Large for Gestational Age
- Direct (conjugated) hyperbilirubinemia > 20% of total bilirubin
- Suspected or confirmed sepsis
- Neonates of diabetic mothers
- Presence of congenital or acquired liver disease
- Receiving Total Parenteral Nutrition (TPN)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Syria1 site, 1 recruiting
- Recruiting
Lattakia University Hospital
Latakia, 0000
Alshelly, +963930052903, Ashraf.m.alshelly@tishreen.edu.sy
Ashraf M Alshelly, MD, Ped.Res.
About this study
Official title: A Prospective Open-label Randomized Controlled Trial , Evaluating the Efficacy of Ursodeoxycholic Acid (UDCA) as an Adjuvant to Phototherapy in Neonates With Indirect Hyperbilirubinemia
This is a prospective, open-label, randomized controlled trial conducted at Lattakia University Hospital (Tishreen University), aiming to evaluate the efficacy of Ursodeoxycholic Acid (UDCA) as an adjuvant to triple phototherapy in the management of indirect hyperbilirubinemia in neonates ≥34 weeks of gestation.
Eligible neonates will be randomly assigned to one of two groups:
Read more
Group A: continuous triple phototherapy only
Group B: UDCA (10 mg/kg/day in two oral doses) in addition to triple continuous phototherapy.
Stratified randomization will be applied according to etiology (hemolytic, non-hemolytic, G6PD deficiency). The primary outcome is the rate and time of decline in total and indirect serum bilirubin to below phototherapy thresholds, monitored every 12 hours until discharge.
This trial seeks to determine whether UDCA may reduce phototherapy duration or enhance bilirubin clearance in a safe and effective manner.
Although this is an open-label trial for care providers and participants , the statstican conducting data analysis will be blinded to group allocation to reduce assessment bias.
Read the detailed description
This is a prospective, open-label, randomized controlled clinical trial designed to assess the efficacy of ursodeoxycholic acid (UDCA) as an adjuvant to continuous triple phototherapy in neonates with indirect hyperbilirubinemia.
The study includes neonates ≥34 weeks gestational age and appropriate for gestational age (AGA), who meet the American Academy of Pediatrics (AAP) criteria for starting phototherapy.
Participants will be randomized 1:1 into two parallel arms:
Group A (Control): Continuous triple phototherapy
Group B (Intervention): Continuous triple phototherapy + oral UDCA at a dose of 10 mg/kg/day divided into two doses, using locally available Ursorasha (Rasha Pharma, license #1991/1192).
Randomization will be performed using stratified block randomization, with three stratification layers to balance known confounding factors across groups:
- Hemolytic jaundice (ABO or Rh incompatibility)
- Non-hemolytic jaundice (physiological or breast milk)
- G6PD deficiency
Total serum bilirubin (TSB) will be monitored every 12 hours and compared across groups. Primary outcome is the time needed for bilirubin to drop below phototherapy threshold, according to age-specific AAP phototherapy nomograms.
Additional secondary analyses will include the rate of bilirubin decline at 24 and 48 hours, need for rescue therapy, and subgroup analysis based on gestational age (late preterm vs term), and jaundice type.
Based on retrospective hospital data, the anticipated enrollment is 70 neonates. However, due to the lower prevalence of G6PD deficiency, this subgroup may not yield enough cases for statistically powered subgroup analysis. It will instead be analyzed descriptively or as exploratory.
The study includes clearly defined inclusion/exclusion criteria and a unified therapeutic protocol applied to all infants.
Inclusion criteria: Neonates ≥34 weeks GA, AGA, with indirect hyperbilirubinemia requiring phototherapy.
Exclusion criteria: Neonates <34 weeks, non-AGA, suspected/confirmed sepsis, TPN, liver disorders, or infants of diabetic mothers.
This protocol was initiated and registered within 21 days of enrolling the first patient. The study has received initial approval from the Department of Pediatrics at Lattakia University Hospital (formerly Tishreen University Hospital) under Committee Decision #70. Final administrative ethics approval from the university is in progress due to procedural delays in our country.
- Conditions
- Hyperbilirubinemia, Neonatal Indirect
- Being tested
- Phototherapy, ursodeoxycholic acid (UDCA)
- Keywords
- Neonatal Jundice, Phototherapy, Ursodeoxycholic acid, UDCA, G6pd Deficiency, Rh incompatibilty, ABO incompatibility, Adjuvant therapy
- Medical subject headings
- Hyperbilirubinemia, Neonatal, Glucosephosphate Dehydrogenase Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PhototherapyProcedure or surgery
Also called Triple continuous phototherapy
Triple continuous phototherapy per AAP Guudelines
ursodeoxycholic acid (UDCA)Drug
Also called Ursodiol, UDCA
10mg/kg/day orally divided in two doses (URSORASHA) . Given with feeds untill the bilirubin level drop down to limits that don't need therapy due to AAP guidelines.
| Study group | Role | What they receive |
|---|---|---|
| Group A - phototherapy only | Active comparator | Infants who have indirect hyperbilirubinemia recieve continuous triple phototherapy only . Receives: Procedure: Phototherapy |
| Group B - phototherapy + UDCA | Experimental | Phototherapy + UDCA Receives: Procedure: Phototherapy; Drug: ursodeoxycholic acid (UDCA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of total serum bilirubin to below phototherapy threshold
Measurement of serum total bilirubin levels every 12 hours until they fall below the phototherapy threshold based on gestational age and postnatal age. Outcome is considered achieved once bilirubin levels drop below threshold and phototherapy can be discontinued .
Measured: Day 0 to Day 7
Time to bilirubin reduction below treatment threshold
Time (in hours) from treatment initiation to TSB falling below phototherapy threshold in each group.
Measured: Day 0 to Day 7
Mean reduction in total serum bilirubin at 12 hours
To compare the average decrease in total serum bilirubin after 12 hours between the two groups.
Measured: 12 hours of starting therapy
Secondary outcomes (8)
Comparison of Hospital stay between both groups
The total length of hospital stay (in days) will be compared between both groups (phototherapy alone and UDCA + phototherapy) to assess the impac5 of UDCA on hospital stay duration.
Measured: Day 0 to Day 7
Comparison of bilirubin reduction between late preterm (34weeks-36weeks+6 days) and term infants (≥37 weeks) in each treatment group.
This outcome aims to evaluate whether the gestational maturity of neonates affects the response to the assigned treatment. The kinetics of bilirubin reduction (mg/dL over time) will be analyzed separately within the phototherapy-only group and the phototherapy + UDCA group, comparing late preterm and term neonates.
Measured: Up to 7 Days
Comparison of bilirubin decline in each gestational age group (preterm vs preterm) and (term vs term) across jaundice types between treatment arms.
This outcome investigates whether the effectiveness of UDCA as an adjuvant varies by both gestational age and jaundice type. Within each gestational age group (late preterm and term), the bilirubin decline trends in rate (mg/dl) will be compared between the treatment groups across each of the following etiologies:
- Hemolytic jaundice
- Non-hemolytic jaundice
- G6PD-related jaundice
Measured: Day 0 to Day 7.
Need for retreatment
percentage of infants who required re-initiation of phototherapy after initial discontinuation in each Arm .
Measured: Day 0 to Day 10 , Up to 3 days after treatment discontinuation.
Incidence of adverse effects in the UDCA group
Any reported side effects in neonates receiving UDCA
Measured: Day 0 to Day 7
Time to bilirubin reduction below threshold between treatment groups within each gestational age category
Time from initiation of treatment to bilirubin falling below treatment threshold for:
- Late preterm (34-36+6 weeks): Group A vs. Group B
- Term (≥37 weeks): Group A vs. Group B
Measured: Up to 7 Days
Time to bilirubin reduction between late preterm and term neonates within each treatment group
To assess whether gestational age affects time to bilirubin normalization within each group.
Measured: Up to 7 Days
Time to bilirubin normalization in each gestational age group across jaundice types
For each gestational age (late preterm, term), compare time to normalization among jaundice types (hemolytic, non-hemolytic, G6PD) between groups.
Measured: Up to 7 Days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start26 Jun 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hyperbilirubinemia, Neonatal IndirectStudies 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tishreen University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashraf Maan Alshelly, Tishreen University Hospital
- Investigators
- Adnan H Dayoub, Prof.Neonat, Study director, Lattakia university hospital (Tishreen university Hospital ) , Lattakia university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07110987
- Sponsor's protocol ID
- Alshelly-UDCA-2025
- Acronym
- UDCA-Neo
- Status last verified
- Apr 2026
- First submitted
- 13 Jul 2025
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodrigues CM, Steer CJ. The therapeutic effects of ursodeoxycholic acid as an anti-apoptotic agent. Expert Opin Investig Drugs. 2001 Jul;10(7):1243-53. doi: 10.1517/13543784.10.7.1243.
PubMed 117722482. Wang H, et al. Effect of ursodeoxycholic acid on neonatal indirect hyperbilirubinemia: A meta-analysis. World J Pediatr. 2022;18(5):375-383. PMID: 35689782
3. Hassan NM, El Said NM. Role of ursodeoxycholic acid in treatment of neonatal indirect hyperbilirubinemia. Iraqi J Pediatr. 2015;32(1):42-47.
Ughasoro MD, Adimorah GN, Chukwudi NK, Nnakenyi ID, Iloh KK, Udemba CE. Reductive effect of ursodeoxycholic acid on bilirubin levels in neonates on phototherapy. Clin Exp Gastroenterol. 2019 Jul 29;12:349-354. doi: 10.2147/CEG.S207523. eCollection 2019.
PubMed 31534356Rezaie M, Gholami R, Jafari M, Haghighinejad H. Evaluating the effect of ursodeoxycholic acid on total bilirubin of neonates with glucose-6-phosphate dehydrogenase deficiency complicated by indirect hyperbilirubinaemia. J Paediatr Child Health. 2021 Aug;57(8):1175-1181. doi: 10.1111/jpc.15411. Epub 2021 Mar 8.
PubMed 33682983
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Open-label Randomized Controlled Trial , Evaluating the Efficacy of Ursodeoxycholic Acid (UDCA) as an Adjuvant to Phototherapy in Neonates With Indirect Hyperbilirubinemia
- ClinicalTrials.gov ID
- NCT07110987
- Acronym / sponsor ID
- UDCA-Neo / Alshelly-UDCA-2025
- Conditions
- Hyperbilirubinemia, Neonatal Indirect
- Keywords
- Neonatal Jundice, Phototherapy, Ursodeoxycholic acid, UDCA, G6pd Deficiency, Rh incompatibilty, ABO incompatibility, Adjuvant therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Tishreen University HospitalUniversity, hospital or other
- Study start
- 26 Jun 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 8 Aug 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.
This is a prospective, open-label, randomized controlled trial conducted at Lattakia University Hospital (Tishreen University), aiming to evaluate the efficacy of Ursodeoxycholic Acid (UDCA) as an adjuvant to triple phototherapy in the management of indirect hyperbilirubinemia in neonates ≥34 weeks of gestation.
Eligible neonates will be randomly assigned to one of two groups:
Group A: continuous triple phototherapy only
Group B: UDCA (10 mg/kg/day in two oral doses) in addition to triple continuous phototherapy.
Stratified randomization will be applied according to etiology (hemolytic, non-hemolytic, G6PD deficiency). The primary outcome is the rate and time of decline in total and indirect serum bilirubin to below phototherapy thresholds, monitored every 12 hours until discharge.
This trial seeks to determine whether UDCA may reduce phototherapy duration or enhance bilirubin clearance in a safe and effective manner.
Although this is an open-label trial for care providers and participants , the statstican conducting data analysis will be blinded to group allocation to reduce assessment bias.
Detailed description
This is a prospective, open-label, randomized controlled clinical trial designed to assess the efficacy of ursodeoxycholic acid (UDCA) as an adjuvant to continuous triple phototherapy in neonates with indirect hyperbilirubinemia.
The study includes neonates ≥34 weeks gestational age and appropriate for gestational age (AGA), who meet the American Academy of Pediatrics (AAP) criteria for starting phototherapy.
Participants will be randomized 1:1 into two parallel arms:
Group A (Control): Continuous triple phototherapy
Group B (Intervention): Continuous triple phototherapy + oral UDCA at a dose of 10 mg/kg/day divided into two doses, using locally available Ursorasha (Rasha Pharma, license #1991/1192).
Randomization will be performed using stratified block randomization, with three stratification layers to balance known confounding factors across groups:
- Hemolytic jaundice (ABO or Rh incompatibility)
- Non-hemolytic jaundice (physiological or breast milk)
- G6PD deficiency
Total serum bilirubin (TSB) will be monitored every 12 hours and compared across groups. Primary outcome is the time needed for bilirubin to drop below phototherapy threshold, according to age-specific AAP phototherapy nomograms.
Additional secondary analyses will include the rate of bilirubin decline at 24 and 48 hours, need for rescue therapy, and subgroup analysis based on gestational age (late preterm vs term), and jaundice type.
Based on retrospective hospital data, the anticipated enrollment is 70 neonates. However, due to the lower prevalence of G6PD deficiency, this subgroup may not yield enough cases for statistically powered subgroup analysis. It will instead be analyzed descriptively or as exploratory.
The study includes clearly defined inclusion/exclusion criteria and a unified therapeutic protocol applied to all infants.
Inclusion criteria: Neonates ≥34 weeks GA, AGA, with indirect hyperbilirubinemia requiring phototherapy.
Exclusion criteria: Neonates <34 weeks, non-AGA, suspected/confirmed sepsis, TPN, liver disorders, or infants of diabetic mothers.
This protocol was initiated and registered within 21 days of enrolling the first patient. The study has received initial approval from the Department of Pediatrics at Lattakia University Hospital (formerly Tishreen University Hospital) under Committee Decision #70. Final administrative ethics approval from the university is in progress due to procedural delays in our country.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A - phototherapy only | Active comparator | Procedure: PhototherapyInfants who have indirect hyperbilirubinemia recieve continuous triple phototherapy only . |
| Group B - phototherapy + UDCA | Experimental | Procedure: Phototherapy, Drug: ursodeoxycholic acid (UDCA)Phototherapy + UDCA |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Neonates with gestational age ≥ 34 weeks
- Appropriate for Gestational Age (AGA) infants
- Presence of indirect hyperbilirubinemia that meets the threshold for phototherapy.
Key exclusion criteria (7 listed)
- Gestational age < 34 weeks
- Small or Large for Gestational Age
- Direct (conjugated) hyperbilirubinemia > 20% of total bilirubin
- Suspected or confirmed sepsis
- Neonates of diabetic mothers
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 |
|---|---|---|
| PhototherapyAlso: Triple continuous phototherapyTriple continuous phototherapy per AAP Guudelines | Procedure or surgery | Group A - phototherapy only, Group B - phototherapy + UDCA |
| ursodeoxycholic acid (UDCA)Also: Ursodiol, UDCA10mg/kg/day orally divided in two doses (URSORASHA) . Given with feeds untill the bilirubin level drop down to limits that don't need therapy due to AAP guidelines. | Drug | Group B - phototherapy + UDCA |
Primary outcome
Reduction of total serum bilirubin to below phototherapy threshold
Time frame: Day 0 to Day 7
Measurement of serum total bilirubin levels every 12 hours until they fall below the phototherapy threshold based on gestational age and postnatal age. Outcome is considered achieved once bilirubin levels drop below threshold and phototherapy can be discontinued .
Time to bilirubin reduction below treatment threshold
Time frame: Day 0 to Day 7
Time (in hours) from treatment initiation to TSB falling below phototherapy threshold in each group.
Mean reduction in total serum bilirubin at 12 hours
Time frame: 12 hours of starting therapy
To compare the average decrease in total serum bilirubin after 12 hours between the two groups.
8 secondary outcomes
Comparison of Hospital stay between both groups
Time frame: Day 0 to Day 7
Comparison of bilirubin reduction between late preterm (34weeks-36weeks+6 days) and term infants (≥37 weeks) in each treatment group.
Time frame: Up to 7 Days
Comparison of bilirubin decline in each gestational age group (preterm vs preterm) and (term vs term) across jaundice types between treatment arms.
Time frame: Day 0 to Day 7.
Need for retreatment
Time frame: Day 0 to Day 10 , Up to 3 days after treatment discontinuation.
Incidence of adverse effects in the UDCA group
Time frame: Day 0 to Day 7
Time to bilirubin reduction below threshold between treatment groups within each gestational age category
Time frame: Up to 7 Days
Time to bilirubin reduction between late preterm and term neonates within each treatment group
Time frame: Up to 7 Days
Time to bilirubin normalization in each gestational age group across jaundice types
Time frame: Up to 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 21 Apr 2026.
- Background: PubMed 11772248Rodrigues CM, Steer CJ. The therapeutic effects of ursodeoxycholic acid as an anti-apoptotic agent. Expert Opin Investig Drugs. 2001 Jul;10(7):1243-53. doi: 10.1517/13543784.10.7.1243.
- Results publication2. Wang H, et al. Effect of ursodeoxycholic acid on neonatal indirect hyperbilirubinemia: A meta-analysis. World J Pediatr. 2022;18(5):375-383. PMID: 35689782
- Results publication3. Hassan NM, El Said NM. Role of ursodeoxycholic acid in treatment of neonatal indirect hyperbilirubinemia. Iraqi J Pediatr. 2015;32(1):42-47.
- Results publication: PubMed 31534356Ughasoro MD, Adimorah GN, Chukwudi NK, Nnakenyi ID, Iloh KK, Udemba CE. Reductive effect of ursodeoxycholic acid on bilirubin levels in neonates on phototherapy. Clin Exp Gastroenterol. 2019 Jul 29;12:349-354. doi: 10.2147/CEG.S207523. eCollection 2019.
- Results publication: PubMed 33682983Rezaie M, Gholami R, Jafari M, Haghighinejad H. Evaluating the effect of ursodeoxycholic acid on total bilirubin of neonates with glucose-6-phosphate dehydrogenase deficiency complicated by indirect hyperbilirubinaemia. J Paediatr Child Health. 2021 Aug;57(8):1175-1181. doi: 10.1111/jpc.15411. Epub 2021 Mar 8.
- PubMed - Meta-analysis on UDCA in neonatesLink provided by the sponsor.
- 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.
Adnan H Dayoub, Prof.Neonat study director
Lattakia university hospital (Tishreen university Hospital ) , Lattakia 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 Phototherapy and ursodeoxycholic acid (UDCA) in people with Hyperbilirubinemia, Neonatal Indirect, run by Tishreen University Hospital at 1 site in Syria.
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 7 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 21 Apr 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 Syria. 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 Ashraf M Alshelly, MD, Ped.Res. (+963930052903, Ashraf.m.alshelly@latakia-univ.edu.sy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of total serum bilirubin to below phototherapy threshold (time frame: Day 0 to Day 7). The study lists 3 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 NCT07110987, which also lists 5 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 21 Apr 2026.