Neonatal Abstinence SyndromePhase 3NCT03097484
The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
A Phase 3 study testing lavender and chamomile essential oils in people with Neonatal Abstinence Syndrome and Aromatherapy, run by John M. Daniel at 1 site in United States.
Trial summary
Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms of Neonatal Abstinence Syndrome Read more about this study
- Who is it for?
- Ages Up to 2 weeks
- Conditions the study is for
- Neonatal Abstinence Syndrome, Aromatherapy
- What is being tested?
- lavender and chamomile essential oils
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2015to 30 Apr 2017
- Phase
- Phase 3
- 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 2 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants greater than or equal to 36 weeks EGA
- Intrauterine opioid exposure
- Primary diagnosis of NAS
- Parental permission to participate
Who cannot join
- Infants less than 36 weeks EGA
- Major congenital anomalies
- Latrogenic drug withdrawal
- Diagnosis of infection or respiratory distress
- Prior initiation of opioid replacement therapy
- Non-English speaking
- Infants with respiratory conditions
Trial locations and contacts
1 site in 1 country.
About this study
Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms of Neonatal Abstinence Syndrome
Read the detailed description
The United States, Appalachia, Eastern Kentucky in particular, is in the midst of a major opioid abuse epidemic. This current epidemic is driven by misuse of prescription painkillers, i.e. Subutex and Saboxone. As prescription pills become more expensive and harder to acquire, addicts are seeking similar, cheaper drugs; such as heroin. From 1998 to 2011, the prevalence of opioid abuse and dependence amongst pregnant women has increased by 127%, from 1.7 per 1000 to 3.9 per 1000. Neonatal Abstinence Syndrome (NAS) or neonatal opioid withdrawal syndrome is a condition produces gastrointestinal and autonomic neurologic dysfunction. Infants with severe withdrawal experience dysregulation of autonomic functions, resulting in feeding difficulty, diarrhea, excessive sleepiness, and tremors.Nearly two thirds of all babies exposed to opioids during gestation will require admission to a neonatal intensive care unit for management of withdrawal symptoms. During a typical year the Neonatal Intensive Care Unit (NICU) at Kentucky Children's Hospital admits approximately 100-120 infants exhibiting NAS symptoms; these infants have a typical length of stay of 24 days if they require pharmacologic treatment.
The mainstay of treatment for NAS involves opioid replacement therapy with morphine to minimize withdrawal symptoms. Once symptoms are well controlled, the infant is said to have been "captured." At this point a slow weaning of his morphine dose occurs. The infants' clinical status is assessed with the Finnegan Scoring system, which examines symptoms such as crying, excessive sleepiness or difficulty sleeping, insomnia, or tremors along with objective findings such as temperature and respiratory rate.
In addition to pharmacotherapy, alternative and complementary medicine techniques are slowly entering the NAS treatment algorithm. Treatments such as music therapy infant massage, kangaroo care, aromatherapy, and acupressure are now employed in NICUs in addition to traditional opioids replacement. However, few studies exist in the literature to evaluate their effectiveness.
Aromatherapy is the practice of using natural essential oils to achieve a desired effect in an individual. Scents such as lavender and chamomile have been documented to have a soothing calming effect. Studies involving infants shown that lavender not only reduce crying and enhance sleep, but also reduce levels of salivary cortisol, a stress hormone. Additionally, aromatherapy is currently used as an adjunctive therapy at the University of Kentucky's Markey Cancer Center.
Salivary cortisol is a non-invasive biomarker that has proven useful for monitoring stress in neonates. It is a simple and painless method for monitoring the stress hormone cortisol. Salivary cortisol has been used successfully in infants as a method to assess infant stress associated with prone position versus supine positioning.These studies have shown that salivary cortisol levels vary with stressful or soothing stimuli.
To date, no dangerous or deleterious effects have been described from traditional inhalational use of aromatherapy or with salivary cortisol sampling. Studies have shown aromatherapy to be an effective adjunctive therapy by proving a calming effect. In our patient population it may prove to be a useful complimentary therapy ultimately reducing infant stress, hospital length of stay, and burden of opioid use. Additionally, salivary cortisol's ease of collection and non-invasive nature make it an ideal biomarker to study.
- Conditions
- Neonatal Abstinence Syndrome, Aromatherapy
- Being tested
- lavender and chamomile essential oils
- Medical subject headings
- Neonatal Abstinence Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lavender and chamomile essential oilsDrug
Also called Lavendula, chamomilla
Our patches are obtained from BioEsse Technologies™. Each patch contains a 50:50 mixture of Lavender and Chamomile essential oils in a 55 microliter standard dose patch. The patches release the aromatherapy over a 2-8 hours period and the diffusion rate of each patch is identical. The back of the patch is layered with a hypoallergenic medical grade adhesive, similar to the material found on ECG leads.
| Study group | Role | What they receive |
|---|---|---|
| Standard therapy plus Aromatherapy | Experimental | These infants will receive aromatherapy, consisting of Lavender and Chamomile essential oils, in addition to standard care, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy. Receives: Drug: lavender and chamomile essential oils |
| Standard therapy ALONE | No intervention | These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of Hospitalization
How long the infant remains hospitalized.
Measured: Up to 4 months
Secondary outcomes (1)
Length of Medication Therapy
How long the infant requires medication to treat symptoms.
Measured: Up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start25 Jul 2015
- Primary completion30 Apr 2017
- Study completion30 Apr 2017
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 (17)Papers the sponsor has linked to this study.
- Other trials for Neonatal Abstinence SyndromeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- John M. Daniel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, John M. Daniel, University of Kentucky
- Investigators
- John M Daniel, MD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097484
- Sponsor's protocol ID
- 15-0159-F2L
- Status last verified
- Apr 2019
- First submitted
- 15 Mar 2017
- Last updated
- 14 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ang JY, Lua JL, Mathur A, Thomas R, Asmar BI, Savasan S, Buck S, Long M, Shankaran S. A randomized placebo-controlled trial of massage therapy on the immune system of preterm infants. Pediatrics. 2012 Dec;130(6):e1549-58. doi: 10.1542/peds.2012-0196. Epub 2012 Nov 12.
PubMed 23147978Candia MF, Osaku EF, Leite MA, Toccolini B, Costa NL, Teixeira SN, Costa CR, Piana PA, Cristovam MA, Osaku NO. Influence of prone positioning on premature newborn infant stress assessed by means of salivary cortisol measurement: pilot study. Rev Bras Ter Intensiva. 2014 Apr-Jun;26(2):169-75. doi: 10.5935/0103-507x.20140025.
PubMed 25028952Conde-Agudelo A, Diaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2014 Apr 22;(4):CD002771. doi: 10.1002/14651858.CD002771.pub3.
PubMed 24752403Field T, Diego M, Hernandez-Reif M, Cisneros W, Feijo L, Vera Y, Gil K, Grina D, Claire He Q. Lavender fragrance cleansing gel effects on relaxation. Int J Neurosci. 2005 Feb;115(2):207-22. doi: 10.1080/00207450590519175.
PubMed 15764002Field T, Field T, Cullen C, Largie S, Diego M, Schanberg S, Kuhn C. Lavender bath oil reduces stress and crying and enhances sleep in very young infants. Early Hum Dev. 2008 Jun;84(6):399-401. doi: 10.1016/j.earlhumdev.2007.10.008. Epub 2007 Nov 28.
PubMed 18053656Filippelli AC, White LF, Spellman LW, Broderick M, Highfield ES, Sommers E, Gardiner P. Non-Insertive Acupuncture and Neonatal Abstinence Syndrome: A Case Series from an Inner City Safety Net Hospital. Glob Adv Health Med. 2012 Sep;1(4):48-52. doi: 10.7453/gahmj.2012.1.4.007.
PubMed 24078899Hayes MJ, Brown MS. Epidemic of prescription opiate abuse and neonatal abstinence. JAMA. 2012 May 9;307(18):1974-5. doi: 10.1001/jama.2012.4526. Epub 2012 Apr 30. No abstract available.
PubMed 22546607Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.
PubMed 23589814Maeda A, Bateman BT, Clancy CR, Creanga AA, Leffert LR. Opioid abuse and dependence during pregnancy: temporal trends and obstetrical outcomes. Anesthesiology. 2014 Dec;121(6):1158-65. doi: 10.1097/ALN.0000000000000472.
PubMed 25405293Namazi M, Amir Ali Akbari S, Mojab F, Talebi A, Alavi Majd H, Jannesari S. Aromatherapy with citrus aurantium oil and anxiety during the first stage of labor. Iran Red Crescent Med J. 2014 Jun;16(6):e18371. doi: 10.5812/ircmj.18371. Epub 2014 Jun 5.
PubMed 25068058Olson SL. Bedside musical care: applications in pregnancy, childbirth, and neonatal care. J Obstet Gynecol Neonatal Nurs. 1998 Sep-Oct;27(5):569-75. doi: 10.1111/j.1552-6909.1998.tb02624.x.
PubMed 9773369Parlier AB, Fagan B, Ramage M, Galvin S. Prenatal care, pregnancy outcomes, and postpartum birth control plans among pregnant women with opiate addictions. South Med J. 2014 Nov;107(11):676-83. doi: 10.14423/SMJ.0000000000000189.
PubMed 25365432Patrick SW, Schumacher RE, Benneyworth BD, Krans EE, McAllister JM, Davis MM. Neonatal abstinence syndrome and associated health care expenditures: United States, 2000-2009. JAMA. 2012 May 9;307(18):1934-40. doi: 10.1001/jama.2012.3951. Epub 2012 Apr 30.
PubMed 22546608Tang SK, Tse MY. Aromatherapy: does it help to relieve pain, depression, anxiety, and stress in community-dwelling older persons? Biomed Res Int. 2014;2014:430195. doi: 10.1155/2014/430195. Epub 2014 Jul 13.
PubMed 25114901Thomas DV. Aromatherapy: mythical, magical, or medicinal? Holist Nurs Pract. 2002 Oct;16(5):8-16. doi: 10.1097/00004650-200210000-00005.
PubMed 12465213
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Aromatherapy on Neonatal Abstinence Syndrome and Salivary Cortisol Levels
- ClinicalTrials.gov ID
- NCT03097484
- Acronym / sponsor ID
- 15-0159-F2L
- Conditions
- Neonatal Abstinence Syndrome, Aromatherapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- John M. DanielUniversity, hospital or other
- Study start
- 25 Jul 2015 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 31 Mar 2017 (actual)
- Results
- Posted 14 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the effectiveness of lavender and chamomile aromatherapy of mitigation of symptoms of Neonatal Abstinence Syndrome
Detailed description
The United States, Appalachia, Eastern Kentucky in particular, is in the midst of a major opioid abuse epidemic. This current epidemic is driven by misuse of prescription painkillers, i.e. Subutex and Saboxone. As prescription pills become more expensive and harder to acquire, addicts are seeking similar, cheaper drugs; such as heroin. From 1998 to 2011, the prevalence of opioid abuse and dependence amongst pregnant women has increased by 127%, from 1.7 per 1000 to 3.9 per 1000. Neonatal Abstinence Syndrome (NAS) or neonatal opioid withdrawal syndrome is a condition produces gastrointestinal and autonomic neurologic dysfunction. Infants with severe withdrawal experience dysregulation of autonomic functions, resulting in feeding difficulty, diarrhea, excessive sleepiness, and tremors.Nearly two thirds of all babies exposed to opioids during gestation will require admission to a neonatal intensive care unit for management of withdrawal symptoms. During a typical year the Neonatal Intensive Care Unit (NICU) at Kentucky Children's Hospital admits approximately 100-120 infants exhibiting NAS symptoms; these infants have a typical length of stay of 24 days if they require pharmacologic treatment.
The mainstay of treatment for NAS involves opioid replacement therapy with morphine to minimize withdrawal symptoms. Once symptoms are well controlled, the infant is said to have been "captured." At this point a slow weaning of his morphine dose occurs. The infants' clinical status is assessed with the Finnegan Scoring system, which examines symptoms such as crying, excessive sleepiness or difficulty sleeping, insomnia, or tremors along with objective findings such as temperature and respiratory rate.
In addition to pharmacotherapy, alternative and complementary medicine techniques are slowly entering the NAS treatment algorithm. Treatments such as music therapy infant massage, kangaroo care, aromatherapy, and acupressure are now employed in NICUs in addition to traditional opioids replacement. However, few studies exist in the literature to evaluate their effectiveness.
Aromatherapy is the practice of using natural essential oils to achieve a desired effect in an individual. Scents such as lavender and chamomile have been documented to have a soothing calming effect. Studies involving infants shown that lavender not only reduce crying and enhance sleep, but also reduce levels of salivary cortisol, a stress hormone. Additionally, aromatherapy is currently used as an adjunctive therapy at the University of Kentucky's Markey Cancer Center.
Salivary cortisol is a non-invasive biomarker that has proven useful for monitoring stress in neonates. It is a simple and painless method for monitoring the stress hormone cortisol. Salivary cortisol has been used successfully in infants as a method to assess infant stress associated with prone position versus supine positioning.These studies have shown that salivary cortisol levels vary with stressful or soothing stimuli.
To date, no dangerous or deleterious effects have been described from traditional inhalational use of aromatherapy or with salivary cortisol sampling. Studies have shown aromatherapy to be an effective adjunctive therapy by proving a calming effect. In our patient population it may prove to be a useful complimentary therapy ultimately reducing infant stress, hospital length of stay, and burden of opioid use. Additionally, salivary cortisol's ease of collection and non-invasive nature make it an ideal biomarker to study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard therapy plus Aromatherapy | Experimental | Drug: lavender and chamomile essential oilsThese infants will receive aromatherapy, consisting of Lavender and Chamomile essential oils, in addition to standard care, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy. |
| Standard therapy ALONE | No intervention | –These infants receive standard care ONLY, which includes morphine replacement therapy, infant massage, PT, OT, and music therapy. |
Who may qualify
- Ages
- Up to 2 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants greater than or equal to 36 weeks EGA
- Intrauterine opioid exposure
- Primary diagnosis of NAS
- Parental permission to participate
Key exclusion criteria (7 listed)
- Infants less than 36 weeks EGA
- Major congenital anomalies
- Latrogenic drug withdrawal
- Diagnosis of infection or respiratory distress
- Prior initiation of opioid replacement therapy
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 |
|---|---|---|
| lavender and chamomile essential oilsAlso: Lavendula, chamomillaOur patches are obtained from BioEsse Technologies™. Each patch contains a 50:50 mixture of Lavender and Chamomile essential oils in a 55 microliter standard dose patch. The patches release the aromatherapy over a 2-8 hours period and the diffusion rate of each patch is identical. The back of the patch is layered with a hypoallergenic medical grade adhesive, similar to the material found on ECG leads. | Drug | Standard therapy plus Aromatherapy |
Primary outcome
Length of Hospitalization
Time frame: Up to 4 months
How long the infant remains hospitalized.
1 secondary outcome
Length of Medication Therapy
Time frame: Up to 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 23147978Ang JY, Lua JL, Mathur A, Thomas R, Asmar BI, Savasan S, Buck S, Long M, Shankaran S. A randomized placebo-controlled trial of massage therapy on the immune system of preterm infants. Pediatrics. 2012 Dec;130(6):e1549-58. doi: 10.1542/peds.2012-0196. Epub 2012 Nov 12.
- Results publication: PubMed 25028952Candia MF, Osaku EF, Leite MA, Toccolini B, Costa NL, Teixeira SN, Costa CR, Piana PA, Cristovam MA, Osaku NO. Influence of prone positioning on premature newborn infant stress assessed by means of salivary cortisol measurement: pilot study. Rev Bras Ter Intensiva. 2014 Apr-Jun;26(2):169-75. doi: 10.5935/0103-507x.20140025.
- Results publication: PubMed 24752403Conde-Agudelo A, Diaz-Rossello JL. Kangaroo mother care to reduce morbidity and mortality in low birthweight infants. Cochrane Database Syst Rev. 2014 Apr 22;(4):CD002771. doi: 10.1002/14651858.CD002771.pub3.
- Results publication: PubMed 15764002Field T, Diego M, Hernandez-Reif M, Cisneros W, Feijo L, Vera Y, Gil K, Grina D, Claire He Q. Lavender fragrance cleansing gel effects on relaxation. Int J Neurosci. 2005 Feb;115(2):207-22. doi: 10.1080/00207450590519175.
- Results publication: PubMed 18053656Field T, Field T, Cullen C, Largie S, Diego M, Schanberg S, Kuhn C. Lavender bath oil reduces stress and crying and enhances sleep in very young infants. Early Hum Dev. 2008 Jun;84(6):399-401. doi: 10.1016/j.earlhumdev.2007.10.008. Epub 2007 Nov 28.
- Results publication: PubMed 24078899Filippelli AC, White LF, Spellman LW, Broderick M, Highfield ES, Sommers E, Gardiner P. Non-Insertive Acupuncture and Neonatal Abstinence Syndrome: A Case Series from an Inner City Safety Net Hospital. Glob Adv Health Med. 2012 Sep;1(4):48-52. doi: 10.7453/gahmj.2012.1.4.007.
- Results publication: PubMed 22546607Hayes MJ, Brown MS. Epidemic of prescription opiate abuse and neonatal abstinence. JAMA. 2012 May 9;307(18):1974-5. doi: 10.1001/jama.2012.4526. Epub 2012 Apr 30. No abstract available.
- Results publication: PubMed 23589814Loewy J, Stewart K, Dassler AM, Telsey A, Homel P. The effects of music therapy on vital signs, feeding, and sleep in premature infants. Pediatrics. 2013 May;131(5):902-18. doi: 10.1542/peds.2012-1367. Epub 2013 Apr 15.
- Results publication: PubMed 25405293Maeda A, Bateman BT, Clancy CR, Creanga AA, Leffert LR. Opioid abuse and dependence during pregnancy: temporal trends and obstetrical outcomes. Anesthesiology. 2014 Dec;121(6):1158-65. doi: 10.1097/ALN.0000000000000472.
- Results publication: PubMed 25068058Namazi M, Amir Ali Akbari S, Mojab F, Talebi A, Alavi Majd H, Jannesari S. Aromatherapy with citrus aurantium oil and anxiety during the first stage of labor. Iran Red Crescent Med J. 2014 Jun;16(6):e18371. doi: 10.5812/ircmj.18371. Epub 2014 Jun 5.
- Results publication: PubMed 9773369Olson SL. Bedside musical care: applications in pregnancy, childbirth, and neonatal care. J Obstet Gynecol Neonatal Nurs. 1998 Sep-Oct;27(5):569-75. doi: 10.1111/j.1552-6909.1998.tb02624.x.
- Results publication: PubMed 25365432Parlier AB, Fagan B, Ramage M, Galvin S. Prenatal care, pregnancy outcomes, and postpartum birth control plans among pregnant women with opiate addictions. South Med J. 2014 Nov;107(11):676-83. doi: 10.14423/SMJ.0000000000000189.
- Individual participant dataSharing planned: No
Related trials for Neonatal Abstinence Syndrome
Active, not recruiting
Effective Caregiving for Neonatal Abstinence Syndrome: Testing an Instructional Mobile Technology Platform for High-Risk Pregnant Women
Neonatal Abstinence Syndrome, Opioid-use Disorder
Not yet recruiting
Recorded Parent/Caregiver Voice for Infants With Neonatal Opioid Withdrawal Syndrome
Neonatal Opioid Withdrawal Syndrome, Prenatal Opioid Exposure
Recruiting
Effect of Music Therapy on Infants With Neonatal Abstinence Syndrome
NAS
Recruiting
An Intervention Mapping Approach to Closing the Gap in Maternal OUD and Infant NAS Care (SUPPORT)
Opioid Use Disorder, Neonatal Abstinence Syndrome
Active, not recruiting
Neurostimulation to Improve NOWS Outcomes
Neonatal Opioid Withdrawal Syndrome, Neonatal Abstinence Syndrome
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.
John M Daniel, MD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing lavender and chamomile essential oils in people with Neonatal Abstinence Syndrome and Aromatherapy, run by John M. Daniel at 1 site 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 4 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: finished, as of the sponsor's last update on 14 May 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 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 May 2019). 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 Hospitalization (time frame: Up to 4 months). 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 NCT03097484, which also lists 17 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 14 May 2019.