Neurodevelopmental OutcomesNCT03867669
Single Patient Room Versus Open Bay in NICU
A study testing Open Bay Unit and Single patient room in people with Neurodevelopmental Outcomes, run by IWK Health Centre at 1 site in Canada.
Trial summary
The NICU at the IWK Health Center in Halifax, Nova Scotia is embarking on a redevelopment project that will see its current open bay design converted to a single room care environment. There will be a period during the redevelopment when new single room care unit will coexist with one open bay unit. Read more about this study
- Who is it for?
- Ages Up to 14 days
- Conditions the study is for
- Neurodevelopmental Outcomes
- What is being tested?
- Open Bay Unit and Single patient room
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteCanada
- Study dates
- 11 Apr 2018to 31 Mar 2023
- 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 Up to 14 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- All very preterm infants born less than 31 weeks gestational age or birth weight less than or equal to 1500 grams
- age less than 14 days
- Multiples will be randomized to the same arm.
Who cannot join
- Babies with major anomalies
- Babies admitted for palliative care only
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Tara R Hatfield, 902-470-6630, tara.hatfield@iwk.nshealth.ca
Hatfield
About this study
Official title: Neurodevelopmental Outcomes at Three Years of Age in Very Preterm Infants (< 31 Weeks Gestational Age) or Very Low Birth Weight (< 1500 Grams) Randomized to Single Patient Rooms Compared to Open Bay Neonatal Intensive Care Unit
The NICU at the IWK Health Center in Halifax, Nova Scotia is embarking on a redevelopment project that will see its current open bay design converted to a single room care environment. There will be a period during the redevelopment when new single room care unit will coexist with one open bay unit. This provides a unique opportunity to explore the effect of the two different environmental designs on both short and long-term outcomes. Preterm infants (under 31 weeks gestational age) and very low birth weight infants (under 1500 grams) will be randomized to either the open bay unit or the single patient room unit, at 36 months corrected age neurodevelopmental outcomes will be assessed.
Read the detailed description
Do very preterm infants (< 31 weeks gestational age) and very low birth weight infants (< 1500 grams) admitted to a single patient room in the NICU have improved long-term neurodevelopmental outcomes when compared to very preterm infants admitted to an open bay in the NICU?
Babies who will be admitted to NICU will be randomized to either the open-bay unit or single room care. The randomization will be achieved through the use of the WANNNT (Winnipeg Assessment of Neonatal Nurses Need Tool) and current patient census; this involves taking 1/3 of the fraction of the patient census on each team and adding it to 2/3 of the fraction of the WANNNT. This methodology was reviewed by several IWK Committees including Ethics, Family Leadership Council, Neonatal care Committee and the Family Centered Care Committee. This randomization is designed to ensure fairness and an equitable workload between the two units.
Eligible study infants are also enrolled in the Perinatal Follow-Up Program (PFU) as a standard of care at the IWK Health Center. The baby's legal guardian signs a consent to be enrolled in the PFU Program and to allow collection and use of data for their child as long as their child cannot be identified from the use of the data. All families of infants admitted to NICU, whether or not they have been enrolled in the PFU Program will receive an information package explaining the single patient room NICU compared with the open bay NICU.
At three years of corrected gestational age, all eligible infants will have the Bayley Scales of Infant and Toddler Development - version 3 assessment completed which evaluates cognitive, language and motor skills. These infants will also be examined for the presence or absence of cerebral palsy.
- Conditions
- Neurodevelopmental Outcomes
- Being tested
- Open Bay Unit, Single patient room
- Keywords
- Developmental Disabilities, Follow-Up Studies, Infant, Premature, Intensive Care Units, Neonatal, randomized controlled trial
- Medical subject headings
- Developmental Disabilities, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Bay UnitOther
The eligible infants will be randomized at birth/admission to either the single patient room (experimental) or the open bay unit (Comparator)
Single patient roomOther
The eligible infants will be randomized at birth/admission to either the single patient room (experimental) or the open bay unit (Comparator)
| Study group | Role | What they receive |
|---|---|---|
| Single Patient Room | Experimental | Patients randomized to this arm will be admitted to a NICU single patient room. Receives: Other: Single patient room |
| Open Bay | Placebo comparator | Patients randomized to this arm will be admitted to the open bay NICU Unit. Receives: Other: Open Bay Unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with neurodevelopmental impairment or death
adverse neurodevelopmental outcome including any of the following: 1. Cerebral palsy, 2. Bayley-III scores (cognitive or language <85), 3. Blindness (vision <20/200 in the best eye) 4. Deafness (bilateral) requiring hearing aids for correction; or 5. Death prior to 36 months corrected gestational age.
Measured: From randomization to age 36 months corrected age
Secondary outcomes (7)
Number of Participants with cerebral palsy
any degree of cerebral palsy (minor = level 1 or 2) (major = level 3-5)
Measured: From randomization to age 36 months corrected age
Number of participants who died
Death before 36 months corrected age
Measured: From randomization to age 36 months corrected age
Number of Participants with low cognitive scores (<85) of the Bayley Scales of Infant and Toddler Development (version III)
<85 on the Bayley Scales of Infant and Toddler Development (version III) represents -1 standard deviations below the mean. (Scale range is 55-145, higher scores are better)
Measured: From randomization to age 36 months corrected age
Number of Participants with low language scores (<85) of the Bayley Scales of Infant and Toddler Development (version III)
<85 on the Bayley Scales of Infant and Toddler Development (version III) which represents -1 standard deviations below the mean. (Scale range is 45-155, higher scores are better)
Measured: From randomization to age 36 months corrected age
Number of Participants with low motor scores (<85) of the Bayley Scales of Infant and Toddler Development (version III)
<85 on the Bayley Scales of Infant and Toddler Development (version III) which represents -1 standard deviations below the mean. (Scale range is 45-155, higher scores are better)
Measured: From randomization to age 36 months corrected age
Number of participants with blindness
vision <20/200 in the best eye
Measured: From randomization to age 36 months corrected age
Number of participants with deafness
Deafness (bilateral) requiring hearing aids for correction
Measured: From randomization to age 36 months corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2019
- Study start11 Apr 2018
- Primary completion31 Aug 2019 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental OutcomesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University
- Responsible party
- Principal investigator, Mike Vincer, IWK Health Centre
- Investigators
- Michael Vincer, Principal investigator, Dalhousie University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03867669
- Sponsor's protocol ID
- Single room vs open bay
- Status last verified
- Mar 2019
- First submitted
- 31 Oct 2018
- Last updated
- 8 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Domanico R, Davis DK, Coleman F, Davis BO. Documenting the NICU design dilemma: comparative patient progress in open-ward and single family room units. J Perinatol. 2011 Apr;31(4):281-8. doi: 10.1038/jp.2010.120. Epub 2010 Nov 11.
PubMed 21072040Erdeve O, Arsan S, Canpolat FE, Ertem IO, Karagol BS, Atasay B, Yurdakok M, Tekinalp G, Turmen T. Does individual room implemented family-centered care contribute to mother-infant interaction in preterm deliveries necessitating neonatal intensive care unit hospitalization? Am J Perinatol. 2009 Feb;26(2):159-64. doi: 10.1055/s-0028-1095186. Epub 2008 Nov 19.
PubMed 19021100Lester BM, Hawes K, Abar B, Sullivan M, Miller R, Bigsby R, Laptook A, Salisbury A, Taub M, Lagasse LL, Padbury JF. Single-family room care and neurobehavioral and medical outcomes in preterm infants. Pediatrics. 2014 Oct;134(4):754-60. doi: 10.1542/peds.2013-4252. Epub 2014 Sep 22.
PubMed 25246623Lester BM, Salisbury AL, Hawes K, Dansereau LM, Bigsby R, Laptook A, Taub M, Lagasse LL, Vohr BR, Padbury JF. 18-Month Follow-Up of Infants Cared for in a Single-Family Room Neonatal Intensive Care Unit. J Pediatr. 2016 Oct;177:84-89. doi: 10.1016/j.jpeds.2016.06.069. Epub 2016 Jul 26.
PubMed 27470693Ortenstrand A, Westrup B, Brostrom EB, Sarman I, Akerstrom S, Brune T, Lindberg L, Waldenstrom U. The Stockholm Neonatal Family Centered Care Study: effects on length of stay and infant morbidity. Pediatrics. 2010 Feb;125(2):e278-85. doi: 10.1542/peds.2009-1511. Epub 2010 Jan 25.
PubMed 20100748Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.
PubMed 9183258Pineda RG, Neil J, Dierker D, Smyser CD, Wallendorf M, Kidokoro H, Reynolds LC, Walker S, Rogers C, Mathur AM, Van Essen DC, Inder T. Alterations in brain structure and neurodevelopmental outcome in preterm infants hospitalized in different neonatal intensive care unit environments. J Pediatr. 2014 Jan;164(1):52-60.e2. doi: 10.1016/j.jpeds.2013.08.047. Epub 2013 Oct 17.
PubMed 24139564Wood-Kaczmar A, Deas E, Wood NW, Abramov AY. The role of the mitochondrial NCX in the mechanism of neurodegeneration in Parkinson's disease. Adv Exp Med Biol. 2013;961:241-9. doi: 10.1007/978-1-4614-4756-6_20.
PubMed 23224884Vohr B, McGowan E, McKinley L, Tucker R, Keszler L, Alksninis B. Differential Effects of the Single-Family Room Neonatal Intensive Care Unit on 18- to 24-Month Bayley Scores of Preterm Infants. J Pediatr. 2017 Jun;185:42-48.e1. doi: 10.1016/j.jpeds.2017.01.056. Epub 2017 Feb 24.
PubMed 28238479White RD, Smith JA, Shepley MM; Committee to Establish Recommended Standards for Newborn ICU Design. Recommended standards for newborn ICU design, eighth edition. J Perinatol. 2013 Apr;33 Suppl 1:S2-16. doi: 10.1038/jp.2013.10.
PubMed 23536026Bayley, N. (2006). Bayley Scales of Infant and Toddler Development: Technical manual (3rd ed.). San Antonio, TX: Harcourt Assessment, Inc.
Stevens, D. C., Munson, D. P., & Khan, M. A. (2016). The single-family room neonatal intensive care environment. NeoReviews, 17(12)(17(12)), e687-e696.
Vincer MJ, Woolcott CG, Inglis DJ, Myles TM, MacDonald SM, Afifi J, Simpson CD, Ghotra S, El-Naggar W, Singh B, Styranko D, Unger S, Mitra S, McMillan DD, Dorling JS. Long-term outcomes of preterm infants admitted to single-family rooms versus an open-bay neonatal intensive care unit: A randomized controlled trial. J Perinatol. 2026 Oct 12. doi: 10.1038/s41372-026-02927-z. Online ahead of print.
PubMed 42864367
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurodevelopmental Outcomes at Three Years of Age in Very Preterm Infants (< 31 Weeks Gestational Age) or Very Low Birth Weight (< 1500 Grams) Randomized to Single Patient Rooms Compared to Open Bay Neonatal Intensive Care Unit
- ClinicalTrials.gov ID
- NCT03867669
- Acronym / sponsor ID
- Single room vs open bay
- Conditions
- Neurodevelopmental Outcomes
- Keywords
- Developmental Disabilities, Follow-Up Studies, Infant, Premature, Intensive Care Units, Neonatal, randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- Dalhousie University
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 31 Aug 2019 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 8 Mar 2019 (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 NICU at the IWK Health Center in Halifax, Nova Scotia is embarking on a redevelopment project that will see its current open bay design converted to a single room care environment. There will be a period during the redevelopment when new single room care unit will coexist with one open bay unit. This provides a unique opportunity to explore the effect of the two different environmental designs on both short and long-term outcomes. Preterm infants (under 31 weeks gestational age) and very low birth weight infants (under 1500 grams) will be randomized to either the open bay unit or the single patient room unit, at 36 months corrected age neurodevelopmental outcomes will be assessed.
Detailed description
Do very preterm infants (< 31 weeks gestational age) and very low birth weight infants (< 1500 grams) admitted to a single patient room in the NICU have improved long-term neurodevelopmental outcomes when compared to very preterm infants admitted to an open bay in the NICU?
Babies who will be admitted to NICU will be randomized to either the open-bay unit or single room care. The randomization will be achieved through the use of the WANNNT (Winnipeg Assessment of Neonatal Nurses Need Tool) and current patient census; this involves taking 1/3 of the fraction of the patient census on each team and adding it to 2/3 of the fraction of the WANNNT. This methodology was reviewed by several IWK Committees including Ethics, Family Leadership Council, Neonatal care Committee and the Family Centered Care Committee. This randomization is designed to ensure fairness and an equitable workload between the two units.
Eligible study infants are also enrolled in the Perinatal Follow-Up Program (PFU) as a standard of care at the IWK Health Center. The baby's legal guardian signs a consent to be enrolled in the PFU Program and to allow collection and use of data for their child as long as their child cannot be identified from the use of the data. All families of infants admitted to NICU, whether or not they have been enrolled in the PFU Program will receive an information package explaining the single patient room NICU compared with the open bay NICU.
At three years of corrected gestational age, all eligible infants will have the Bayley Scales of Infant and Toddler Development - version 3 assessment completed which evaluates cognitive, language and motor skills. These infants will also be examined for the presence or absence of cerebral palsy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single Patient Room | Experimental | Other: Single patient roomPatients randomized to this arm will be admitted to a NICU single patient room. |
| Open Bay | Placebo comparator | Other: Open Bay UnitPatients randomized to this arm will be admitted to the open bay NICU Unit. |
Who may qualify
- Ages
- Up to 14 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- All very preterm infants born less than 31 weeks gestational age or birth weight less than or equal to 1500 grams
- age less than 14 days
- Multiples will be randomized to the same arm.
Key exclusion criteria (2 listed)
- Babies with major anomalies
- Babies admitted for palliative care only
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 |
|---|---|---|
| Open Bay UnitThe eligible infants will be randomized at birth/admission to either the single patient room (experimental) or the open bay unit (Comparator) | Other | Open Bay |
| Single patient roomThe eligible infants will be randomized at birth/admission to either the single patient room (experimental) or the open bay unit (Comparator) | Other | Single Patient Room |
Primary outcome
Number of Participants with neurodevelopmental impairment or death
Time frame: From randomization to age 36 months corrected age
adverse neurodevelopmental outcome including any of the following: 1. Cerebral palsy, 2. Bayley-III scores (cognitive or language <85), 3. Blindness (vision <20/200 in the best eye) 4. Deafness (bilateral) requiring hearing aids for correction; or 5. Death prior to 36 months corrected gestational age.
7 secondary outcomes
Number of Participants with cerebral palsy
Time frame: From randomization to age 36 months corrected age
Number of participants who died
Time frame: From randomization to age 36 months corrected age
Number of Participants with low cognitive scores (<85) of the Bayley Scales of Infant and Toddler Development (version III)
Time frame: From randomization to age 36 months corrected age
Number of Participants with low language scores (<85) of the Bayley Scales of Infant and Toddler Development (version III)
Time frame: From randomization to age 36 months corrected age
Number of Participants with low motor scores (<85) of the Bayley Scales of Infant and Toddler Development (version III)
Time frame: From randomization to age 36 months corrected age
Number of participants with blindness
Time frame: From randomization to age 36 months corrected age
Number of participants with deafness
Time frame: From randomization to age 36 months corrected age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2019.
- Background: PubMed 21072040Domanico R, Davis DK, Coleman F, Davis BO. Documenting the NICU design dilemma: comparative patient progress in open-ward and single family room units. J Perinatol. 2011 Apr;31(4):281-8. doi: 10.1038/jp.2010.120. Epub 2010 Nov 11.
- Background: PubMed 19021100Erdeve O, Arsan S, Canpolat FE, Ertem IO, Karagol BS, Atasay B, Yurdakok M, Tekinalp G, Turmen T. Does individual room implemented family-centered care contribute to mother-infant interaction in preterm deliveries necessitating neonatal intensive care unit hospitalization? Am J Perinatol. 2009 Feb;26(2):159-64. doi: 10.1055/s-0028-1095186. Epub 2008 Nov 19.
- Background: PubMed 25246623Lester BM, Hawes K, Abar B, Sullivan M, Miller R, Bigsby R, Laptook A, Salisbury A, Taub M, Lagasse LL, Padbury JF. Single-family room care and neurobehavioral and medical outcomes in preterm infants. Pediatrics. 2014 Oct;134(4):754-60. doi: 10.1542/peds.2013-4252. Epub 2014 Sep 22.
- Background: PubMed 27470693Lester BM, Salisbury AL, Hawes K, Dansereau LM, Bigsby R, Laptook A, Taub M, Lagasse LL, Vohr BR, Padbury JF. 18-Month Follow-Up of Infants Cared for in a Single-Family Room Neonatal Intensive Care Unit. J Pediatr. 2016 Oct;177:84-89. doi: 10.1016/j.jpeds.2016.06.069. Epub 2016 Jul 26.
- Background: PubMed 20100748Ortenstrand A, Westrup B, Brostrom EB, Sarman I, Akerstrom S, Brune T, Lindberg L, Waldenstrom U. The Stockholm Neonatal Family Centered Care Study: effects on length of stay and infant morbidity. Pediatrics. 2010 Feb;125(2):e278-85. doi: 10.1542/peds.2009-1511. Epub 2010 Jan 25.
- Background: PubMed 9183258Palisano R, Rosenbaum P, Walter S, Russell D, Wood E, Galuppi B. Development and reliability of a system to classify gross motor function in children with cerebral palsy. Dev Med Child Neurol. 1997 Apr;39(4):214-23. doi: 10.1111/j.1469-8749.1997.tb07414.x.
- Background: PubMed 24139564Pineda RG, Neil J, Dierker D, Smyser CD, Wallendorf M, Kidokoro H, Reynolds LC, Walker S, Rogers C, Mathur AM, Van Essen DC, Inder T. Alterations in brain structure and neurodevelopmental outcome in preterm infants hospitalized in different neonatal intensive care unit environments. J Pediatr. 2014 Jan;164(1):52-60.e2. doi: 10.1016/j.jpeds.2013.08.047. Epub 2013 Oct 17.
- Background: PubMed 23224884Wood-Kaczmar A, Deas E, Wood NW, Abramov AY. The role of the mitochondrial NCX in the mechanism of neurodegeneration in Parkinson's disease. Adv Exp Med Biol. 2013;961:241-9. doi: 10.1007/978-1-4614-4756-6_20.
- Background: PubMed 28238479Vohr B, McGowan E, McKinley L, Tucker R, Keszler L, Alksninis B. Differential Effects of the Single-Family Room Neonatal Intensive Care Unit on 18- to 24-Month Bayley Scores of Preterm Infants. J Pediatr. 2017 Jun;185:42-48.e1. doi: 10.1016/j.jpeds.2017.01.056. Epub 2017 Feb 24.
- Background: PubMed 23536026White RD, Smith JA, Shepley MM; Committee to Establish Recommended Standards for Newborn ICU Design. Recommended standards for newborn ICU design, eighth edition. J Perinatol. 2013 Apr;33 Suppl 1:S2-16. doi: 10.1038/jp.2013.10.
- BackgroundBayley, N. (2006). Bayley Scales of Infant and Toddler Development: Technical manual (3rd ed.). San Antonio, TX: Harcourt Assessment, Inc.
- BackgroundStevens, D. C., Munson, D. P., & Khan, M. A. (2016). The single-family room neonatal intensive care environment. NeoReviews, 17(12)(17(12)), e687-e696.
- Winnipeg Regional Health Authority. Winnipeg Assessment of Neonatal Nurses Need Tool (WANNNT). Retrieved 01/15, 2018Link 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. This study is not recruiting at the moment.
Michael Vincer principal investigator
Dalhousie 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 Open Bay Unit and Single patient room in people with Neurodevelopmental Outcomes, run by IWK Health Centre 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 2 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 8 Mar 2019. 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. Some participants in this study may receive a placebo. 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 Tara Hatfield (902-470-6630, tara.hatfield@iwk.nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with neurodevelopmental impairment or death (time frame: From randomization to age 36 months corrected age). 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 NCT03867669, which also lists 13 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 8 Mar 2019.