Neonatal ResuscitationNCT03660033
ECG Monitoring During NRP: a False Sense of Security?
A study testing ECG in delivery room in people with Neonatal Resuscitation and Simulation, run by St. Justine's Hospital.
Trial summary
ECG monitoring is relatively new mode of monitoring in the delivery room. While its use has been positively received by many practitioners of NRP, concerns have been raised about delaying chest compressions for a pulseless baby who may have electrical cardiac activity. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Neonatal Resuscitation, Simulation
- What is being tested?
- ECG in delivery room
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Oct 2018to May 2019
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Regular providers of neonatal resuscitation at our institution
- This includes residents, fellows, neonatal nurse practitioners, attending physicians, transport nurses and respiratory therapists
- Consents to the study (through a process of recruitment and informed consent)
Who cannot join
- Any individual who does not regularly participate in neonatal resuscitation in the delivery room
- Any individual who refuses consent
Trial locations and contacts
No sites are listed yet.
About this study
ECG monitoring is relatively new mode of monitoring in the delivery room. While its use has been positively received by many practitioners of NRP, concerns have been raised about delaying chest compressions for a pulseless baby who may have electrical cardiac activity. It is unknown whether ECG leads do indeed provide a false sense of security in the delivery room. The investigators will be investigating this further using simulation.
Read the detailed description
The aim of this study is to evaluate whether the presence of ECG monitoring has an impact on the resuscitative steps of NRP providers.
Participants will be invited to the mother-child simulation center at CHU Sainte-Justine for a 60 minute simulation session during which they will complete two neonatal resuscitation scenarios (one of pulseless VT and the other of PEA). They will be randomized to either having access or not to ECG monitoring during the resuscitations.
Investigators will plan to have participant teams perform the second scenario two weeks after the first scenario. This will be to hopefully mitigate repetition bias, as both scenarios will involve a pulseless newborn.
- Resuscitation team and equipment Participants will be invited to be part of a three-person resuscitation team (physician or nurse practitioner, respiratory therapist and nurse) to complete the scenarios. A high-fidelity manikin will be utilized in all scenarios (Laerdal © Sim NewB). All necessary equipment as per NRP guidelines for neonatal resuscitation will be present at the bedside for the team to use.
- Simulation scenarios In each group, the participants will be asked to proceed with the resuscitation of a newborn in the delivery room. Two different rhythms were chosen to see if changes seen with one abnormal appearing rhythm (ventricular tachycardia) can be replicated with a second normal appearing rhythm (PEA). Both of these rhythms cannot be considered normal as the newborn is pulseless. For the VT scenario, the newborn will be born in pulseless VT, with a pulse reading of 120 on the ECG monitor. There will have been an uneventful delivery. Participants will be expected to perform defibrillation, endotracheal intubation, chest compressions, umbilical venous catheter placement and intravenous epinephrine. Once the epinephrine is administered, the manikin will have a palpable pulse of 100, which will end the scenario. For the PEA scenario, the newborn will have a history of volume loss secondary to placenta previa. Because of the prolonged in utero asphyxia, the baby will be born in PEA arrest, with a heart rate display on the monitor of 80-90. In this scenario, resuscitative steps will include positive pressure ventilation, endotracheal intubation, chest compressions, umbilical venous catheter placement and intravenous epinephrine. Once the epinephrine is administered, the manikin will have a palpable pulse of 100, which will end the scenario.
- Video recording of scenarios In order to be precise about time measurements, the investigators will record the resuscitations with the help of a video camera. The camera shot will only include the newborn manikin and the resuscitation team's hands. These recordings will not provide any identification data and will be for the sole purpose collecting data for this study. The video will be analyzed by the principal investigator and deleted in accordance with IRB guidelines.
The following data below will be collected. Please note that all time measurements will be from the start of the scenario.
- Time to pulse checks
- Time to application of ECG electrodes (for relevant scenarios)
- Number of subsequent pulse checks after application of ECG electrodes
- Method of pulse check (auscultation, palpation of the umbilical cord or brachial pulse)
- Time to start of chest compressions
- Time to administration of epinephrine
A questionnaire for each participant will collect the following data prior to the simulations: occupation, number of years of training in neonatology, number of years of experience in neonatology, last NRP course and approximate number of resuscitations in past year.
- Conditions
- Neonatal Resuscitation, Simulation
- Being tested
- ECG in delivery room
- Keywords
- Simulation, NRP, Resuscitation, ECG, Electrocardiogram
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECG in delivery roomDiagnostic test
See arm/group discussions
| Study group | Role | What they receive |
|---|---|---|
| With ECG | Experimental | These teams will have access to ECG monitoring (intervention) during the scenario Receives: Diagnostic Test: ECG in delivery room |
| Without ECG | No intervention | These teams will NOT have access to ECG monitoring during the scenario |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to pulse check
Time to pulse check once simulated manikin is programmed to be pulseless
Measured: 1 minute
Time to start of chest compressions
Time to start of chest compressions once simulated manikin is programmed to be pulseless
Measured: 2 minutes
Time to administration of epinephrine
Time to administration of epinephrine once simulated manikin is programmed to be pulseless
Measured: 3-4 minutes
Secondary outcomes (5)
Number of subsequent pulse checks
After initial pulse check
Measured: 1-10 minutes
Method of pulse check
Directly visualize (using video review) if participants use auscultation or palpation to check the pulse
Measured: 0-10 minutes
Time of electrode placement
FOR ECG GROUP ONLY: time to application of ECG electrodes
Measured: 0-10 minutes
Is the rhythm recognized?
FOR ECG GROUP ONLY: is the rhythm recognized Y/N?
Measured: 0-10 minutes
Time to rhythm recognition
FOR ECG GROUP ONLY: measure at what time the team finally recognizes the baby's cardiac rhythm
Measured: 0-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study startOct 2018 (estimated)
- Primary completionFeb 2019 (estimated)
- Study completionMay 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Neonatal ResuscitationStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Participants will be invited to the mother-child simulation centre at CHU Sainte-Justine for a 60 minute simulation session during which they will complete two neonatal resuscitation scenarios (one of pulseless VT and the other of PEA). They will be randomized to either having access or not to ECG monitoring during the resuscitations.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Andrew Assaad, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660033
- Sponsor's protocol ID
- 2019-2022
- Status last verified
- Sep 2018
- First submitted
- 11 Jul 2018
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ali N, Sawyer T, Barry J, Grover T, Ades A. Resuscitation practices for infants in the NICU, PICU and CICU: results of a national survey. J Perinatol. 2017 Feb;37(2):172-176. doi: 10.1038/jp.2016.193. Epub 2016 Oct 27.
PubMed 27787506Fouzas S, Priftis KN, Anthracopoulos MB. Pulse oximetry in pediatric practice. Pediatrics. 2011 Oct;128(4):740-52. doi: 10.1542/peds.2011-0271. Epub 2011 Sep 19.
PubMed 21930554Hannibal GB. It started with Einthoven: the history of the ECG and cardiac monitoring. AACN Adv Crit Care. 2011 Jan-Mar;22(1):93-6. doi: 10.1097/10.1097/NCI.0b013e3181fffe4c. No abstract available.
PubMed 21297396Hay WW Jr, Rodden DJ, Collins SM, Melara DL, Hale KA, Fashaw LM. Reliability of conventional and new pulse oximetry in neonatal patients. J Perinatol. 2002 Jul-Aug;22(5):360-6. doi: 10.1038/sj.jp.7210740.
PubMed 12082469Jaeggi E, Ohman A. Fetal and Neonatal Arrhythmias. Clin Perinatol. 2016 Mar;43(1):99-112. doi: 10.1016/j.clp.2015.11.007.
PubMed 26876124Kamlin CO, Dawson JA, O'Donnell CP, Morley CJ, Donath SM, Sekhon J, Davis PG. Accuracy of pulse oximetry measurement of heart rate of newborn infants in the delivery room. J Pediatr. 2008 Jun;152(6):756-60. doi: 10.1016/j.jpeds.2008.01.002. Epub 2008 Mar 6.
PubMed 18492509Katheria A, Rich W, Finer N. Electrocardiogram provides a continuous heart rate faster than oximetry during neonatal resuscitation. Pediatrics. 2012 Nov;130(5):e1177-81. doi: 10.1542/peds.2012-0784. Epub 2012 Oct 22.
PubMed 23090347Kevat AC, Bullen DV, Davis PG, Kamlin CO. A systematic review of novel technology for monitoring infant and newborn heart rate. Acta Paediatr. 2017 May;106(5):710-720. doi: 10.1111/apa.13786. Epub 2017 Mar 6.
PubMed 28199732Wyllie J, Perlman JM, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation. 2015 Oct;95:e169-201. doi: 10.1016/j.resuscitation.2015.07.045. Epub 2015 Oct 15. No abstract available.
PubMed 26477424Voogdt KG, Morrison AC, Wood FE, van Elburg RM, Wyllie JP. A randomised, simulated study assessing auscultation of heart rate at birth. Resuscitation. 2010 Aug;81(8):1000-3. doi: 10.1016/j.resuscitation.2010.03.021. Epub 2010 May 18.
PubMed 20483522Singh JK, Kamlin CO, Morley CJ, O'Donnell CP, Donath SM, Davis PG. Accuracy of pulse oximetry in assessing heart rate of infants in the neonatal intensive care unit. J Paediatr Child Health. 2008 May;44(5):273-5. doi: 10.1111/j.1440-1754.2007.01250.x. Epub 2007 Nov 12.
PubMed 17999668Maxwell LG, Harris AP, Sendak MJ, Donham RT. Monitoring the resuscitation of preterm infants in the delivery room using pulse oximetry. Clin Pediatr (Phila). 1987 Jan;26(1):18-20. doi: 10.1177/000992288702600102.
PubMed 3791833O'Donnell CP, Kamlin CO, Davis PG, Morley CJ. Feasibility of and delay in obtaining pulse oximetry during neonatal resuscitation. J Pediatr. 2005 Nov;147(5):698-9. doi: 10.1016/j.jpeds.2005.07.025.
PubMed 16291367Louis D, Sundaram V, Kumar P. Pulse oximeter sensor application during neonatal resuscitation: a randomized controlled trial. Pediatrics. 2014 Mar;133(3):476-82. doi: 10.1542/peds.2013-2175. Epub 2014 Feb 17.
PubMed 24534410Phillipos E, Solevag AL, Pichler G, Aziz K, van Os S, O'Reilly M, Cheung PY, Schmolzer GM. Heart Rate Assessment Immediately after Birth. Neonatology. 2016;109(2):130-8. doi: 10.1159/000441940. Epub 2015 Dec 19.
PubMed 26684743
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ECG Monitoring During NRP: a False Sense of Security?
- ClinicalTrials.gov ID
- NCT03660033
- Acronym / sponsor ID
- 2019-2022
- Conditions
- Neonatal Resuscitation, Simulation
- Keywords
- Simulation, NRP, Resuscitation, ECG, Electrocardiogram
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Oct 2018 (estimated)
- Primary completion
- Feb 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 6 Sep 2018 (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.
ECG monitoring is relatively new mode of monitoring in the delivery room. While its use has been positively received by many practitioners of NRP, concerns have been raised about delaying chest compressions for a pulseless baby who may have electrical cardiac activity. It is unknown whether ECG leads do indeed provide a false sense of security in the delivery room. The investigators will be investigating this further using simulation.
Detailed description
The aim of this study is to evaluate whether the presence of ECG monitoring has an impact on the resuscitative steps of NRP providers.
Participants will be invited to the mother-child simulation center at CHU Sainte-Justine for a 60 minute simulation session during which they will complete two neonatal resuscitation scenarios (one of pulseless VT and the other of PEA). They will be randomized to either having access or not to ECG monitoring during the resuscitations.
Investigators will plan to have participant teams perform the second scenario two weeks after the first scenario. This will be to hopefully mitigate repetition bias, as both scenarios will involve a pulseless newborn.
- Resuscitation team and equipment Participants will be invited to be part of a three-person resuscitation team (physician or nurse practitioner, respiratory therapist and nurse) to complete the scenarios. A high-fidelity manikin will be utilized in all scenarios (Laerdal © Sim NewB). All necessary equipment as per NRP guidelines for neonatal resuscitation will be present at the bedside for the team to use.
- Simulation scenarios In each group, the participants will be asked to proceed with the resuscitation of a newborn in the delivery room. Two different rhythms were chosen to see if changes seen with one abnormal appearing rhythm (ventricular tachycardia) can be replicated with a second normal appearing rhythm (PEA). Both of these rhythms cannot be considered normal as the newborn is pulseless. For the VT scenario, the newborn will be born in pulseless VT, with a pulse reading of 120 on the ECG monitor. There will have been an uneventful delivery. Participants will be expected to perform defibrillation, endotracheal intubation, chest compressions, umbilical venous catheter placement and intravenous epinephrine. Once the epinephrine is administered, the manikin will have a palpable pulse of 100, which will end the scenario. For the PEA scenario, the newborn will have a history of volume loss secondary to placenta previa. Because of the prolonged in utero asphyxia, the baby will be born in PEA arrest, with a heart rate display on the monitor of 80-90. In this scenario, resuscitative steps will include positive pressure ventilation, endotracheal intubation, chest compressions, umbilical venous catheter placement and intravenous epinephrine. Once the epinephrine is administered, the manikin will have a palpable pulse of 100, which will end the scenario.
- Video recording of scenarios In order to be precise about time measurements, the investigators will record the resuscitations with the help of a video camera. The camera shot will only include the newborn manikin and the resuscitation team's hands. These recordings will not provide any identification data and will be for the sole purpose collecting data for this study. The video will be analyzed by the principal investigator and deleted in accordance with IRB guidelines.
The following data below will be collected. Please note that all time measurements will be from the start of the scenario.
- Time to pulse checks
- Time to application of ECG electrodes (for relevant scenarios)
- Number of subsequent pulse checks after application of ECG electrodes
- Method of pulse check (auscultation, palpation of the umbilical cord or brachial pulse)
- Time to start of chest compressions
- Time to administration of epinephrine
A questionnaire for each participant will collect the following data prior to the simulations: occupation, number of years of training in neonatology, number of years of experience in neonatology, last NRP course and approximate number of resuscitations in past year.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be invited to the mother-child simulation centre at CHU Sainte-Justine for a 60 minute simulation session during which they will complete two neonatal resuscitation scenarios (one of pulseless VT and the other of PEA). They will be randomized to either having access or not to ECG monitoring during the resuscitations.
| Arm | Type | Receives |
|---|---|---|
| With ECG | Experimental | Diagnostic Test: ECG in delivery roomThese teams will have access to ECG monitoring (intervention) during the scenario |
| Without ECG | No intervention | –These teams will NOT have access to ECG monitoring during the scenario |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Regular providers of neonatal resuscitation at our institution
- This includes residents, fellows, neonatal nurse practitioners, attending physicians, transport nurses and respiratory therapists
- Consents to the study (through a process of recruitment and informed consent)
Key exclusion criteria (2 listed)
- Any individual who does not regularly participate in neonatal resuscitation in the delivery room
- Any individual who refuses consent
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 |
|---|---|---|
| ECG in delivery roomSee arm/group discussions | Diagnostic test | With ECG |
Primary outcome
Time to pulse check
Time frame: 1 minute
Time to pulse check once simulated manikin is programmed to be pulseless
Time to start of chest compressions
Time frame: 2 minutes
Time to start of chest compressions once simulated manikin is programmed to be pulseless
Time to administration of epinephrine
Time frame: 3-4 minutes
Time to administration of epinephrine once simulated manikin is programmed to be pulseless
5 secondary outcomes
Number of subsequent pulse checks
Time frame: 1-10 minutes
Method of pulse check
Time frame: 0-10 minutes
Time of electrode placement
Time frame: 0-10 minutes
Is the rhythm recognized?
Time frame: 0-10 minutes
Time to rhythm recognition
Time frame: 0-10 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Background: PubMed 27787506Ali N, Sawyer T, Barry J, Grover T, Ades A. Resuscitation practices for infants in the NICU, PICU and CICU: results of a national survey. J Perinatol. 2017 Feb;37(2):172-176. doi: 10.1038/jp.2016.193. Epub 2016 Oct 27.
- Background: PubMed 21930554Fouzas S, Priftis KN, Anthracopoulos MB. Pulse oximetry in pediatric practice. Pediatrics. 2011 Oct;128(4):740-52. doi: 10.1542/peds.2011-0271. Epub 2011 Sep 19.
- Background: PubMed 21297396Hannibal GB. It started with Einthoven: the history of the ECG and cardiac monitoring. AACN Adv Crit Care. 2011 Jan-Mar;22(1):93-6. doi: 10.1097/10.1097/NCI.0b013e3181fffe4c. No abstract available.
- Background: PubMed 12082469Hay WW Jr, Rodden DJ, Collins SM, Melara DL, Hale KA, Fashaw LM. Reliability of conventional and new pulse oximetry in neonatal patients. J Perinatol. 2002 Jul-Aug;22(5):360-6. doi: 10.1038/sj.jp.7210740.
- Background: PubMed 26876124Jaeggi E, Ohman A. Fetal and Neonatal Arrhythmias. Clin Perinatol. 2016 Mar;43(1):99-112. doi: 10.1016/j.clp.2015.11.007.
- Background: PubMed 18492509Kamlin CO, Dawson JA, O'Donnell CP, Morley CJ, Donath SM, Sekhon J, Davis PG. Accuracy of pulse oximetry measurement of heart rate of newborn infants in the delivery room. J Pediatr. 2008 Jun;152(6):756-60. doi: 10.1016/j.jpeds.2008.01.002. Epub 2008 Mar 6.
- Background: PubMed 23090347Katheria A, Rich W, Finer N. Electrocardiogram provides a continuous heart rate faster than oximetry during neonatal resuscitation. Pediatrics. 2012 Nov;130(5):e1177-81. doi: 10.1542/peds.2012-0784. Epub 2012 Oct 22.
- Background: PubMed 28199732Kevat AC, Bullen DV, Davis PG, Kamlin CO. A systematic review of novel technology for monitoring infant and newborn heart rate. Acta Paediatr. 2017 May;106(5):710-720. doi: 10.1111/apa.13786. Epub 2017 Mar 6.
- Background: PubMed 26477424Wyllie J, Perlman JM, Kattwinkel J, Wyckoff MH, Aziz K, Guinsburg R, Kim HS, Liley HG, Mildenhall L, Simon WM, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Part 7: Neonatal resuscitation: 2015 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Resuscitation. 2015 Oct;95:e169-201. doi: 10.1016/j.resuscitation.2015.07.045. Epub 2015 Oct 15. No abstract available.
- Background: PubMed 20483522Voogdt KG, Morrison AC, Wood FE, van Elburg RM, Wyllie JP. A randomised, simulated study assessing auscultation of heart rate at birth. Resuscitation. 2010 Aug;81(8):1000-3. doi: 10.1016/j.resuscitation.2010.03.021. Epub 2010 May 18.
- Background: PubMed 17999668Singh JK, Kamlin CO, Morley CJ, O'Donnell CP, Donath SM, Davis PG. Accuracy of pulse oximetry in assessing heart rate of infants in the neonatal intensive care unit. J Paediatr Child Health. 2008 May;44(5):273-5. doi: 10.1111/j.1440-1754.2007.01250.x. Epub 2007 Nov 12.
- Background: PubMed 3791833Maxwell LG, Harris AP, Sendak MJ, Donham RT. Monitoring the resuscitation of preterm infants in the delivery room using pulse oximetry. Clin Pediatr (Phila). 1987 Jan;26(1):18-20. doi: 10.1177/000992288702600102.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing ECG in delivery room in people with Neonatal Resuscitation and Simulation, run by St. Justine's Hospital.
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 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael-Andrew Assaad, MD, MMEd (c) (514-771-9697, michael-andrew.assaad@mail.mcgill.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to pulse check (time frame: 1 minute). 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 NCT03660033, which also lists 15 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 6 Sep 2018.