BronchiolitisNCT01014910
Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis
A study testing Continuous pulse oximetry monitoring and Intermittent pulse oximetry monitoring in people with Bronchiolitis and Hypoxia, run by Children's Mercy Hospital Kansas City at 4 sites in United States.
Trial summary
Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome cause by different types of viruses and occurs in young children. Although bronchiolitis is a widespread and fairly common illness in children, pediatricians vary significantly in how it is treated. Read more about this study
- Who is it for?
- Ages Up to 24 months
- Conditions the study is for
- Bronchiolitis, Hypoxia
- What is being tested?
- Continuous pulse oximetry monitoring and Intermittent pulse oximetry monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 161 participants
- Where
- 4 sitesUnited States
- Study dates
- Dec 2009to Sep 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children less than or equal to 24 months old with a history of term delivery (gestational age ≥37 weeks) admitted with a presumptive diagnosis of bronchiolitis
- Bronchiolitis will be defined as an episode of wheezing or increased work of breathing associated with signs of an upper respiratory tract infection experienced by a patient
- Enrollment within 24 hours of admission
Who cannot join
- History of severe cardiac or pulmonary illness, including but not limited to bronchopulmonary dysplasia, chronic lung disease, asthma/reactive airway disease, congenital heart disease, heart failure, and cardiothoracic surgery
- History of home albuterol use for asthma or reactive airway disease
- History of use of bronchodilator with successful patient response to the medication
- Use of corticosteroids within the past two weeks up to day of admission
- Use of antibiotics after admission for suspected pneumonia or similar pulmonary disease
- History of premature birth (<37 weeks gestation)
Show all 14Show fewer
- History of receiving palivizumab (anti-RSV antibody)
- Diagnosis of chronic immune deficiency, hematologic dyscrasia, or cancer
- Chronic treatment with immunosuppressants
- Parents/guardians unable to give informed consent in English
- Need for PICU transfer at any point during illness
- Transfer from an outside institution where patient was hospitalized for ≥12 hours
- Previous enrollment in this study
- Pediatric attending refuses to comply with study protocol
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Missouri Children's Hospital
Columbia, Missouri, 65212
Children's Mercy Hospital
Kansas City, Missouri, 64108
Hasbro Children's Hospital
Providence, Rhode Island, 02903
Christus Santa Rosa Children's Hospital
San Antonio, Texas, 78207
About this study
Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome cause by different types of viruses and occurs in young children. Although bronchiolitis is a widespread and fairly common illness in children, pediatricians vary significantly in how it is treated. This includes how children are monitored for their oxygen status when not receiving supplemental oxygen. Studies suggest that continuous pulse oximetry measurement of children admitted to the hospital with bronchiolitis regardless of use of supplemental oxygen prolongs their hospital stay. This increases the cost of care for these patients and increases their risk of hospital-associated complications.
This study is a randomized trial of continuous pulse oximeter use in patients admitted with bronchiolitis versus transitioning patients not requiring oxygen to intermittent pulse oximetry monitoring. The investigators hypothesize that this will decrease length of stay as well as associated costs of care and number of medical interventions performed in the hospital.
Read the detailed description
Background: Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome caused by different viruses. It is the most common LRTI in children under 24 months old, accounting for approximately 90,000 hospitalizations annually and costing over $700 million in children under 12 months. Health care providers vary in diagnosis and management, however. In 2006 the American Academy of Pediatrics (AAP) released guidelines for bronchiolitis management in an effort to standardize clinical practice. Part of these guidelines recommends patients admitted to the hospital receive supplemental oxygen if they are persistently hypoxic, which is defined as pulse oximeter readings persistently below 90%. However, this recommendation is based on expert opinion.
Research has previously shown healthy infants routinely experience brief episodes of decreased oxygen levels while sleeping without significant health effects. Other studies demonstrate no relationship between short intervals of transient or mildly decreased oxygen levels and long-term mental or developmental delays. Furthermore, children with bronchiolitis remain hospitalized longer without any appreciable improvement in the course or outcome of their illness when continuously monitored for oxygen level.
Widespread pulse oximeter use has increased hospitalization rates over 250%, and close monitoring increases length of stay for children who otherwise could be discharged home. The 2006 guidelines discourage continuous pulse oximetry monitoring in children not requiring supplemental oxygen, but health care providers routinely ignore this recommendation. No studies have assessed the impact of more strictly adhering to the practices recommended by the AAP.
Research Procedures: This is a randomized control study and is a multi-site collaboration with University of Missouri Children's Hospital in Columbia, Missouri. Children admitted to the study sites with bronchiolitis will be batch randomized (i.e. randomized separately at each site) to undergo either continuous pulse oximetry monitoring throughout the entire hospitalization or receive intermittent monitoring when not on supplemental oxygen. Patients will additionally receive all care standard to the management of their illness. Of note, the proposed intervention is the recommended standard of care for oxygen monitoring compared to the general practice used at both study sites. Researchers will then review charts after discharge for length of stay, number of medical interventions performed, diagnostic testing completed, and treatments provided. Cost of stay for patients in each group will be estimated and compared as well. Patients will be involved in the study for their entire admission.
- Conditions
- Bronchiolitis, Hypoxia
- Being tested
- Continuous pulse oximetry monitoring, Intermittent pulse oximetry monitoring
- Keywords
- Bronchiolitis, Hypoxia, Pulse, Oximetry, Hospitalized
- Medical subject headings
- Bronchiolitis, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous pulse oximetry monitoringOther
Also called Continuous pulse ox
Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen.
Intermittent pulse oximetry monitoringDevice
Also called Intermittent pulse ox
Placement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved.
| Study group | Role | What they receive |
|---|---|---|
| Continuous pulse oximetry monitoring | Active comparator | Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen. Receives: Other: Continuous pulse oximetry monitoring |
| Intermittent pulse oximetry monitoring | Active comparator | Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved. Receives: Device: Intermittent pulse oximetry monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Stay in the Hospital
Measured: Summarized from admission to hospital discharge
Secondary outcomes (1)
Clinical Deterioration Necessitating Transfer to Higher Level of Care
Measured: Summarized from admission to hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionSep 2014
- Study completionSep 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for BronchiolitisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Mercy Hospital Kansas City
- Sponsor type
- University, hospital or other
- Collaborators
- Baylor University, Lifespan, University of Missouri, Kansas City
- Responsible party
- Sponsor
- Investigators
- Michael P Koster, MD, Principal investigator, Hasbro Children's HospitalRussell J McCulloh, MD, Principal investigator, Children's Mercy Hospital Kansas CityVanessa Hill, MD, Principal investigator, Christus Santa Rosa Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01014910
- Sponsor's protocol ID
- CMTT# 4151-09
- Status last verified
- Aug 2021
- First submitted
- 16 Nov 2009
- Last updated
- 16 Sep 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: IRB approval at participating institutions does not provide an avenue for sharing study data after study completion.
Publications
Shay DK, Holman RC, Roosevelt GE, Clarke MJ, Anderson LJ. Bronchiolitis-associated mortality and estimates of respiratory syncytial virus-associated deaths among US children, 1979-1997. J Infect Dis. 2001 Jan 1;183(1):16-22. doi: 10.1086/317655. Epub 2000 Nov 10.
PubMed 11076709Willson DF, Horn SD, Hendley JO, Smout R, Gassaway J. Effect of practice variation on resource utilization in infants hospitalized for viral lower respiratory illness. Pediatrics. 2001 Oct;108(4):851-5. doi: 10.1542/peds.108.4.851.
PubMed 11581435Bass JL, Corwin M, Gozal D, Moore C, Nishida H, Parker S, Schonwald A, Wilker RE, Stehle S, Kinane TB. The effect of chronic or intermittent hypoxia on cognition in childhood: a review of the evidence. Pediatrics. 2004 Sep;114(3):805-16. doi: 10.1542/peds.2004-0227.
PubMed 15342857Hunt CE, Corwin MJ, Lister G, Weese-Mayer DE, Neuman MR, Tinsley L, Baird TM, Keens TG, Cabral HJ. Longitudinal assessment of hemoglobin oxygen saturation in healthy infants during the first 6 months of age. Collaborative Home Infant Monitoring Evaluation (CHIME) Study Group. J Pediatr. 1999 Nov;135(5):580-6. doi: 10.1016/s0022-3476(99)70056-9.
PubMed 10547246Bergman AB. Pulse oximetry: good technology misapplied. Arch Pediatr Adolesc Med. 2004 Jun;158(6):594-5. doi: 10.1001/archpedi.158.6.594. No abstract available.
PubMed 15184226Unger S, Cunningham S. Effect of oxygen supplementation on length of stay for infants hospitalized with acute viral bronchiolitis. Pediatrics. 2008 Mar;121(3):470-5. doi: 10.1542/peds.2007-1135.
PubMed 18310194Luo Z, Fu Z, Liu E, Xu X, Fu X, Peng D, Liu Y, Li S, Zeng F, Yang X. Nebulized hypertonic saline treatment in hospitalized children with moderate to severe viral bronchiolitis. Clin Microbiol Infect. 2011 Dec;17(12):1829-33. doi: 10.1111/j.1469-0691.2010.03304.x. Epub 2010 Jul 15.
PubMed 20636429Ralston S, Hill V, Martinez M. Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010 Sep;126(3):e520-5. doi: 10.1542/peds.2009-3105. Epub 2010 Aug 16.
PubMed 20713480McCulloh R, Koster M, Ralston S, Johnson M, Hill V, Koehn K, Weddle G, Alverson B. Use of Intermittent vs Continuous Pulse Oximetry for Nonhypoxemic Infants and Young Children Hospitalized for Bronchiolitis: A Randomized Clinical Trial. JAMA Pediatr. 2015 Oct;169(10):898-904. doi: 10.1001/jamapediatrics.2015.1746.
PubMed 26322819
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intermittent Versus Continuous Pulse Oximetry Monitoring of Infants Admitted for Bronchiolitis
- ClinicalTrials.gov ID
- NCT01014910
- Acronym / sponsor ID
- CMTT# 4151-09
- Conditions
- Bronchiolitis, Hypoxia
- Keywords
- Bronchiolitis, Hypoxia, Pulse, Oximetry, Hospitalized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Children's Mercy Hospital Kansas CityUniversity, hospital or other
- Collaborators
- Baylor University, Lifespan, University of Missouri, Kansas City
- Study start
- Dec 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Nov 2009 (estimated)
- Results
- Posted 21 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome cause by different types of viruses and occurs in young children. Although bronchiolitis is a widespread and fairly common illness in children, pediatricians vary significantly in how it is treated. This includes how children are monitored for their oxygen status when not receiving supplemental oxygen. Studies suggest that continuous pulse oximetry measurement of children admitted to the hospital with bronchiolitis regardless of use of supplemental oxygen prolongs their hospital stay. This increases the cost of care for these patients and increases their risk of hospital-associated complications.
This study is a randomized trial of continuous pulse oximeter use in patients admitted with bronchiolitis versus transitioning patients not requiring oxygen to intermittent pulse oximetry monitoring. The investigators hypothesize that this will decrease length of stay as well as associated costs of care and number of medical interventions performed in the hospital.
Detailed description
Background: Bronchiolitis is a lower respiratory tract infection (LRTI) syndrome caused by different viruses. It is the most common LRTI in children under 24 months old, accounting for approximately 90,000 hospitalizations annually and costing over $700 million in children under 12 months. Health care providers vary in diagnosis and management, however. In 2006 the American Academy of Pediatrics (AAP) released guidelines for bronchiolitis management in an effort to standardize clinical practice. Part of these guidelines recommends patients admitted to the hospital receive supplemental oxygen if they are persistently hypoxic, which is defined as pulse oximeter readings persistently below 90%. However, this recommendation is based on expert opinion.
Research has previously shown healthy infants routinely experience brief episodes of decreased oxygen levels while sleeping without significant health effects. Other studies demonstrate no relationship between short intervals of transient or mildly decreased oxygen levels and long-term mental or developmental delays. Furthermore, children with bronchiolitis remain hospitalized longer without any appreciable improvement in the course or outcome of their illness when continuously monitored for oxygen level.
Widespread pulse oximeter use has increased hospitalization rates over 250%, and close monitoring increases length of stay for children who otherwise could be discharged home. The 2006 guidelines discourage continuous pulse oximetry monitoring in children not requiring supplemental oxygen, but health care providers routinely ignore this recommendation. No studies have assessed the impact of more strictly adhering to the practices recommended by the AAP.
Research Procedures: This is a randomized control study and is a multi-site collaboration with University of Missouri Children's Hospital in Columbia, Missouri. Children admitted to the study sites with bronchiolitis will be batch randomized (i.e. randomized separately at each site) to undergo either continuous pulse oximetry monitoring throughout the entire hospitalization or receive intermittent monitoring when not on supplemental oxygen. Patients will additionally receive all care standard to the management of their illness. Of note, the proposed intervention is the recommended standard of care for oxygen monitoring compared to the general practice used at both study sites. Researchers will then review charts after discharge for length of stay, number of medical interventions performed, diagnostic testing completed, and treatments provided. Cost of stay for patients in each group will be estimated and compared as well. Patients will be involved in the study for their entire admission.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Continuous pulse oximetry monitoring | Active comparator | Other: Continuous pulse oximetry monitoringPatients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen. |
| Intermittent pulse oximetry monitoring | Active comparator | Device: Intermittent pulse oximetry monitoringPatients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved. |
Who may qualify
- Ages
- Up to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children less than or equal to 24 months old with a history of term delivery (gestational age ≥37 weeks) admitted with a presumptive diagnosis of bronchiolitis
- Bronchiolitis will be defined as an episode of wheezing or increased work of breathing associated with signs of an upper respiratory tract infection experienced by a patient
- Enrollment within 24 hours of admission
Key exclusion criteria (14 listed)
- History of severe cardiac or pulmonary illness, including but not limited to bronchopulmonary dysplasia, chronic lung disease, asthma/reactive airway disease, congenital heart disease, heart failure, and cardiothoracic surgery
- History of home albuterol use for asthma or reactive airway disease
- History of use of bronchodilator with successful patient response to the medication
- Use of corticosteroids within the past two weeks up to day of admission
- Use of antibiotics after admission for suspected pneumonia or similar pulmonary disease
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 |
|---|---|---|
| Continuous pulse oximetry monitoringAlso: Continuous pulse oxPlacement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive continuous pulse oximetry monitoring throughout their hospital stay regardless of their need for supplemental oxygen. | Other | Continuous pulse oximetry monitoring |
| Intermittent pulse oximetry monitoringAlso: Intermittent pulse oxPlacement of a pulse oximeter to monitor oxygenation status. This is usually placed on a toe, finger, or ear lobe and held in place with adhesive tape. Patients will receive pulse oximetry monitoring during vital signs checks (every 4 hours) and as indicated clinically when not on supplemental oxygen. When patients require supplemental oxygen they will be continuously monitored by pulse oximetry until their oxygen requirement has resolved. | Device | Intermittent pulse oximetry monitoring |
Primary outcome
Length of Stay in the Hospital
Time frame: Summarized from admission to hospital discharge
1 secondary outcome
Clinical Deterioration Necessitating Transfer to Higher Level of Care
Time frame: Summarized from admission to hospital discharge
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11076709Shay DK, Holman RC, Roosevelt GE, Clarke MJ, Anderson LJ. Bronchiolitis-associated mortality and estimates of respiratory syncytial virus-associated deaths among US children, 1979-1997. J Infect Dis. 2001 Jan 1;183(1):16-22. doi: 10.1086/317655. Epub 2000 Nov 10.
- Background: PubMed 11581435Willson DF, Horn SD, Hendley JO, Smout R, Gassaway J. Effect of practice variation on resource utilization in infants hospitalized for viral lower respiratory illness. Pediatrics. 2001 Oct;108(4):851-5. doi: 10.1542/peds.108.4.851.
- Background: PubMed 15342857Bass JL, Corwin M, Gozal D, Moore C, Nishida H, Parker S, Schonwald A, Wilker RE, Stehle S, Kinane TB. The effect of chronic or intermittent hypoxia on cognition in childhood: a review of the evidence. Pediatrics. 2004 Sep;114(3):805-16. doi: 10.1542/peds.2004-0227.
- Background: PubMed 10547246Hunt CE, Corwin MJ, Lister G, Weese-Mayer DE, Neuman MR, Tinsley L, Baird TM, Keens TG, Cabral HJ. Longitudinal assessment of hemoglobin oxygen saturation in healthy infants during the first 6 months of age. Collaborative Home Infant Monitoring Evaluation (CHIME) Study Group. J Pediatr. 1999 Nov;135(5):580-6. doi: 10.1016/s0022-3476(99)70056-9.
- Background: PubMed 15184226Bergman AB. Pulse oximetry: good technology misapplied. Arch Pediatr Adolesc Med. 2004 Jun;158(6):594-5. doi: 10.1001/archpedi.158.6.594. No abstract available.
- Background: PubMed 18310194Unger S, Cunningham S. Effect of oxygen supplementation on length of stay for infants hospitalized with acute viral bronchiolitis. Pediatrics. 2008 Mar;121(3):470-5. doi: 10.1542/peds.2007-1135.
- Background: PubMed 20636429Luo Z, Fu Z, Liu E, Xu X, Fu X, Peng D, Liu Y, Li S, Zeng F, Yang X. Nebulized hypertonic saline treatment in hospitalized children with moderate to severe viral bronchiolitis. Clin Microbiol Infect. 2011 Dec;17(12):1829-33. doi: 10.1111/j.1469-0691.2010.03304.x. Epub 2010 Jul 15.
- Background: PubMed 20713480Ralston S, Hill V, Martinez M. Nebulized hypertonic saline without adjunctive bronchodilators for children with bronchiolitis. Pediatrics. 2010 Sep;126(3):e520-5. doi: 10.1542/peds.2009-3105. Epub 2010 Aug 16.
- Derived from this study: PubMed 26322819McCulloh R, Koster M, Ralston S, Johnson M, Hill V, Koehn K, Weddle G, Alverson B. Use of Intermittent vs Continuous Pulse Oximetry for Nonhypoxemic Infants and Young Children Hospitalized for Bronchiolitis: A Randomized Clinical Trial. JAMA Pediatr. 2015 Oct;169(10):898-904. doi: 10.1001/jamapediatrics.2015.1746.
- Individual participant dataSharing planned: No. IRB approval at participating institutions does not provide an avenue for sharing study data after study completion.
Related trials for Bronchiolitis
Active, not recruiting
Respiratory Support and Treatment for Efficient and Cost-Effective Care
Bronchiolitis
RecruitingPhase 3
A Study to Investigate the Efficacy and Safety of Belumosudil Compared With Best Available Therapy in Participants Aged 12 Years or Older With Chronic Graft-versus-host Disease
Chronic Graft Versus Host Disease
Not yet recruiting
Influence of Patient Positioning During Nasal Lavage
Acute Upper Respiratory Tract Infections, Nasal Obstruction
Recruiting
Effect of Anomia Rehabilitation Combined With Metacognitive Training in Patients With Chronic Vascular Aphasia
Aphasia, Stroke
Not yet recruiting
A New ECP Protocol for the Treatment of cGVHD
Chronic Graft Versus Host Disease
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 P Koster, MD principal investigator
Hasbro Children's Hospital
Russell J McCulloh, MD principal investigator
Children's Mercy Hospital Kansas City
Vanessa Hill, MD principal investigator
Christus Santa Rosa Children's Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous pulse oximetry monitoring and Intermittent pulse oximetry monitoring in people with Bronchiolitis and Hypoxia, run by Children's Mercy Hospital Kansas City at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 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: finished, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of Stay in the Hospital (time frame: Summarized from admission to hospital discharge). 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 NCT01014910, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.