ResuscitationMONITORNCT03256578
Monitoring Neonatal Resuscitation Trial
A study testing New Life Box Respiratory Function Monitor in people with Resuscitation and Neonatal Prematurity, run by University of Pennsylvania at 1 site in United States.
Trial summary
This is a randomized trial to determine if a visible respiratory function monitor (RFM) displaying realtime measurements of delivered inflations improves clinical providers ability to perform positive pressure ventilation (PPV) within a pre-defined target tidal volume in preterm infants after birth. Read more about this study
- Who is it for?
- Ages 24 to 28 weeks
- Conditions the study is for
- Resuscitation, Neonatal Prematurity, Positive-Pressure Respiration
- What is being tested?
- New Life Box Respiratory Function Monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2017to 20 Sep 2021
- 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 24 to 28 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age (GA) 24 - 27 6/7 weeks at birth, by best obstetrical
- Receive positive pressure ventilation during delivery room resuscitation
Who cannot join
- Known major anomalies including that may affect measured cardiorespiratory parameters: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease, pulmonary hypoplasia
- RFM not available during resuscitation
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Multi-center Randomized Controlled Trial of Respiratory Function Monitoring During Stabilization of Preterm Infants at Birth
This is a randomized trial to determine if a visible respiratory function monitor (RFM) displaying realtime measurements of delivered inflations improves clinical providers ability to perform positive pressure ventilation (PPV) within a pre-defined target tidal volume in preterm infants after birth.
Read the detailed description
Recently, it has been demonstrated that the use of a respiratory function monitor (RFM) can guide PPV in the DR.(Wood, Schmolzer) In this study, the New Life Box, (Advanced Life Diagnostics, Weener, Germany) a neonatal Respiratory Monitor (RFM), will be used to measure and calculate inflation pressures, flow, and tidal volumes in all enrolled infants. The New Life Box uses a small variable orifice anemometer to measure gas flow in and out of a face-mask or endotracheal tube. This signal is automatically integrated to provide inspired (Vti) and expired (Vte) tidal volume. The difference equals the leak from the facemask or endotracheal tube. Complete airway obstruction occurs when no flow of gas into or away from the infant is seen during a positive pressure inflation. The RFM can also calculate and measure respiratory rate and minute volume, inflations and spontaneous inspirations, and all ventilation pressures. Using customized software heart rate, oxygen saturation and expired carbon dioxide can be integrated into the RFM.
The NewLife Box monitor presents graphical information for pressure, flow, and volume. In addition, the monitor displays numeric data for pressure (PIP and PEEP), tidal volume (Vti, Vte), flow, respiratory rate and percent leak. The monitor integrates and displays physiologic data streaming from the patient (heart rate and oxygen saturation) as well as FiO2 from an oxygen analyzer in the inspiratory limb of the respiratory circuit. If enabled, the monitor can incorporate video captured from an external camera. The video serves as a helpful aid in the interpretation of the events during the RFM waveform recordings.
The use of an RFM in the DR has the potential to improve neonatal respiratory support and reduce lung injury.
The primary objective of this study is to test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the proportion of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.
- Being tested
- New Life Box Respiratory Function Monitor
- Keywords
- Resuscitation, Neonatal Prematurity, Positive-Pressure Ventilation, Respiratory Function Monitor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New Life Box Respiratory Function MonitorDevice
The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.
| Study group | Role | What they receive |
|---|---|---|
| RFM visible | Experimental | During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen. Receives: Device: New Life Box Respiratory Function Monitor |
| RFM masked | No intervention | During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg
To test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the percentage of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.
Measured: the first 15 minutes of resuscitation
Secondary outcomes (25)
Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life
Median percentage of oxygen saturation (SpO2) captured on the Respiratory Function Monitor in the first 5 minutes of life
Measured: approximately first 5 minutes of life
Heart Rate in the First 10 Minutes of Life
Median Heart rate captured on the Respiratory Function Monitor between 3 and10 minutes of life
Measured: between 3 and 10 minutes of life
Percentage of Time With Mask Leak During PPV Ventilation
Percentage of time with significant mask leak (defined as > 60%) during the duration of PPV ventilation per infant in the first 15 minutes of resuscitation.
Measured: approximately first 15 minutes of resuscitation
Percentage of PPV Inflations With Airway Obstruction
Percentage of PPV inflations with airway obstruction in the first 15 minutes of resuscitation. Airway obstruction is defined as Vte <1 mL/kg, with minimal mask leak (<25%) during an inflation and flattening of the flow waves.
Measured: approximately first 15 minutes of resuscitation
Percentage of PPV Inflations With Inadequate Tidal Volume
Percentage of PPV inflations with inadequate tidal volume defined as Vte <4 ml/kg in the first 15 minutes of resuscitation.
Measured: approximately first 15 minutes of resuscitation
Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life
Median percentage of Oxygen saturation (SpO2) captured on the Respiratory Function Monitor between 3 and 10 minutes of life
Measured: Between 3 and 10 minutes of life
Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life
Median fraction of inspired oxygen (FiO2) provided to the infant between 3 and 10 minutes of life
Measured: between 3 and 10 minutes of life
Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life
Total duration of time where FiO2 of 100% is delivered to the patient in first 10 minutes of life will be calculated taking into consideration birth weight, tidal volume, respiratory rate, FiO2 and timing of stabilization.
Measured: approximately first 10 minutes of life
Number of Participants Receiving Endotracheal Intubation in the Delivery Room
Number of Participants receiving Endotracheal Intubation in the delivery room from time of birth to admission to NICU
Measured: from time of birth to admission to NICU
Number of Participants Requiring Inotropes for Circulatory Support
Number of participants requiring inotropes for circulatory support in the Neonatal Intensive Care Unit in the first 3 days after birth
Measured: within the first 3 days after birth
Number of Participants With Pneumothorax
Number of participants with pneumothorax in the first 72 hours after birth reported by a radiologist masked to the intervention
Measured: in the first 72 hours after birth
Number of Participants With Pulmonary Interstitial Emphysema
Number of participants with Pulmonary Interstitial Emphysema in the first 72 hours after birth reported by a radiologist masked to the intervention
Measured: in the first 72 hours of life
Number of Participants With Abnormal Cranial Ultrasound Findings
Number of participants with abnormal cranial ultrasound findings (i) all intraventricular hemorrhage, (ii) severe - ie. Papile grade III and IV intraventricular hemorrhage, (iii) cystic periventricular leukomalacia through study completion, an average of 4 months
Measured: through study completion, an average of 4 months
Duration of Endotracheal Ventilation
Duration of endotracheal (ET) ventilation days through study completion, an average of 4 months
Measured: days through study completion, an average of 4 months
Duration of Non-invasive Ventilation
Duration of non-invasive ventilation, days through study completion, an average of 4 months
Measured: days through study completion, an average of 4 months
Duration of Supplemental Oxygen Therapy
Duration of supplemental oxygen therapy days through study completion, an average of 4 months
Measured: days through study completion, an average of 4 months
Total Duration of Assisted Ventilation
Total duration of assisted ventilation (ET, CPAP) in hours through study completion, an average of 4 months
Measured: through study completion, an average of 4 months
Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia
Number of participants with a diagnosis of bronchopulmonary dysplasia (BPD) at 36 weeks corrected gestational age defined as the need for supplementary oxygen and/or any form respiratory support
Measured: at 36 weeks corrected gestational age
Neonatal Mortality
Neonatal mortality from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first
Measured: from time of birth until discharge from hospital, up to 44 weeks corrected gestational age
Composite Outcome of Death or BPD
Composite outcome of death or BPD. BPD assessed at corrected gestational age of 36 weeks; death assessed from time of birth until discharge, up to 44 weeks corrected gestational age
Measured: BPD assessed at corrected gestational age of 36 weeks; death assessed from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first
Number of Participants With Retinopathy of Prematurity Requiring Treatment
Number of participants with Retinopathy of prematurity requiring treatment before hospital discharge, an average of 4 months
Measured: before hospital discharge, an average of 4 months
Number of Participants With a Diagnosis of Necrotizing Enterocolitis
Number of participants with a diagnosis of Necrotizing enterocolitis grade 2 or more before hospital discharge, an average of 4 months
Measured: before hospital discharge, an average of 4 months
Number of Participants Requiring Fluid Boluses for Circulatory Support
Number of participants requiring fluid boluses for circulatory support in the Neonatal Intensive Care Unit within the first 3 days of life
Measured: within the first 3 days of life
Number of Participants With Endotracheal Intubation in the NICU
Number of Participants with Endotracheal Intubation in the NICU in the first 24 hours of life
Measured: in the first 24 hours of life
Neonatal Mortality in the Delivery Room
Neonatal Mortality in the delivery room from time of birth until transfer to NICU
Measured: from time of birth until transfer to NICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2017
- Study start20 Feb 2017
- Primary completion17 May 2019
- Study completion20 Sep 2021
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 (3)Papers the sponsor has linked to this study.
- Other trials for ResuscitationStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible infants are either randomized to the intervention, where the clinical team will be able to directly observe the monitor or randomized to the RFM-masked display arm, where they will only see a black screen.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center, Royal Women's Hospital in Melbourne, Australia, Maternal & Children's University Hospital, Valencia, Spain, Vittore Buzzi Children's Hospital, Karolinska University Hospital
- Responsible party
- Principal investigator, Elizabeth Foglia, University of Pennsylvania
- Investigators
- Arjan te Pas, MD, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03256578
- Sponsor's protocol ID
- 826695
- Other IDs
- NTR4104
- Acronym
- MONITOR
- Status last verified
- Nov 2021
- First submitted
- 15 Aug 2017
- Last updated
- 22 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Wood FE, Morley CJ, Dawson JA, Davis PG. A respiratory function monitor improves mask ventilation. Arch Dis Child Fetal Neonatal Ed. 2008 Sep;93(5):F380-1. doi: 10.1136/adc.2007.120097. Epub 2008 Jan 11.
PubMed 18192329Schmolzer GM, Kamlin OC, Dawson JA, te Pas AB, Morley CJ, Davis PG. Respiratory monitoring of neonatal resuscitation. Arch Dis Child Fetal Neonatal Ed. 2010 Jul;95(4):F295-303. doi: 10.1136/adc.2009.165878. Epub 2009 Sep 22.
PubMed 19776023van Zanten HA, Kuypers KLAM, van Zwet EW, van Vonderen JJ, Kamlin COF, Springer L, Lista G, Cavigioli F, Vento M, Nunez-Ramiro A, Oberthuer A, Kribs A, Kuester H, Horn S, Weinberg DD, Foglia EE, Morley CJ, Davis PG, Te Pas AB. A multi-centre randomised controlled trial of respiratory function monitoring during stabilisation of very preterm infants at birth. Resuscitation. 2021 Oct;167:317-325. doi: 10.1016/j.resuscitation.2021.07.012. Epub 2021 Jul 22.
PubMed 34302924
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center Randomized Controlled Trial of Respiratory Function Monitoring During Stabilization of Preterm Infants at Birth
- ClinicalTrials.gov ID
- NCT03256578
- Acronym / sponsor ID
- MONITOR / 826695
- Keywords
- Resuscitation, Neonatal Prematurity, Positive-Pressure Ventilation, Respiratory Function Monitor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Leiden University Medical Center, Royal Women's Hospital in Melbourne, Australia, Maternal & Children's University Hospital, Valencia, Spain, Vittore Buzzi Children's Hospital, Karolinska University Hospital
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 17 May 2019 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 22 Aug 2017 (actual)
- Results
- Posted 19 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized trial to determine if a visible respiratory function monitor (RFM) displaying realtime measurements of delivered inflations improves clinical providers ability to perform positive pressure ventilation (PPV) within a pre-defined target tidal volume in preterm infants after birth.
Detailed description
Recently, it has been demonstrated that the use of a respiratory function monitor (RFM) can guide PPV in the DR.(Wood, Schmolzer) In this study, the New Life Box, (Advanced Life Diagnostics, Weener, Germany) a neonatal Respiratory Monitor (RFM), will be used to measure and calculate inflation pressures, flow, and tidal volumes in all enrolled infants. The New Life Box uses a small variable orifice anemometer to measure gas flow in and out of a face-mask or endotracheal tube. This signal is automatically integrated to provide inspired (Vti) and expired (Vte) tidal volume. The difference equals the leak from the facemask or endotracheal tube. Complete airway obstruction occurs when no flow of gas into or away from the infant is seen during a positive pressure inflation. The RFM can also calculate and measure respiratory rate and minute volume, inflations and spontaneous inspirations, and all ventilation pressures. Using customized software heart rate, oxygen saturation and expired carbon dioxide can be integrated into the RFM.
The NewLife Box monitor presents graphical information for pressure, flow, and volume. In addition, the monitor displays numeric data for pressure (PIP and PEEP), tidal volume (Vti, Vte), flow, respiratory rate and percent leak. The monitor integrates and displays physiologic data streaming from the patient (heart rate and oxygen saturation) as well as FiO2 from an oxygen analyzer in the inspiratory limb of the respiratory circuit. If enabled, the monitor can incorporate video captured from an external camera. The video serves as a helpful aid in the interpretation of the events during the RFM waveform recordings.
The use of an RFM in the DR has the potential to improve neonatal respiratory support and reduce lung injury.
The primary objective of this study is to test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the proportion of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Eligible infants are either randomized to the intervention, where the clinical team will be able to directly observe the monitor or randomized to the RFM-masked display arm, where they will only see a black screen.
| Arm | Type | Receives |
|---|---|---|
| RFM visible | Experimental | Device: New Life Box Respiratory Function MonitorDuring resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants can see the information displayed on the New Life Box Respiratory Function Monitor screen. |
| RFM masked | No intervention | –During resuscitation immediately following delivery the providers involved in the care of enrolled eligible infants cannot see the information displayed on the New Life Box Respiratory Function Monitor screen. Though the display is masked, data is collected in the background. |
Who may qualify
- Ages
- 24 to 28 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age (GA) 24 - 27 6/7 weeks at birth, by best obstetrical
- Receive positive pressure ventilation during delivery room resuscitation
Key exclusion criteria (2 listed)
- Known major anomalies including that may affect measured cardiorespiratory parameters: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease, pulmonary hypoplasia
- RFM not available during resuscitation
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 |
|---|---|---|
| New Life Box Respiratory Function MonitorThe intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth. | Device | RFM visible |
Primary outcome
Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg
Time frame: the first 15 minutes of resuscitation
To test the hypothesis that observing the data and waveforms displayed on an RFM during the provision of PPV to preterm infants (24-27 6/7 weeks gestation) after birth will increase the percentage of inflations performed with a predefined VTe "safe range" of 4 - 8 mls/kg.
25 secondary outcomes
Percentage of Oxygen Saturation (SpO2) in the First 5 Minutes of Life
Time frame: approximately first 5 minutes of life
Heart Rate in the First 10 Minutes of Life
Time frame: between 3 and 10 minutes of life
Percentage of Time With Mask Leak During PPV Ventilation
Time frame: approximately first 15 minutes of resuscitation
Percentage of PPV Inflations With Airway Obstruction
Time frame: approximately first 15 minutes of resuscitation
Percentage of PPV Inflations With Inadequate Tidal Volume
Time frame: approximately first 15 minutes of resuscitation
Percentage of Oxygen Saturation (SpO2) in the First 10 Minutes of Life
Time frame: Between 3 and 10 minutes of life
Fraction of Inspired Oxygen (FiO2) Provided in the First 10 Minutes of Life
Time frame: between 3 and 10 minutes of life
Total Duration With FiO2 of 100% Delivered in the First 10 Minutes of Life
Time frame: approximately first 10 minutes of life
Number of Participants Receiving Endotracheal Intubation in the Delivery Room
Time frame: from time of birth to admission to NICU
Number of Participants Requiring Inotropes for Circulatory Support
Time frame: within the first 3 days after birth
Number of Participants With Pneumothorax
Time frame: in the first 72 hours after birth
Number of Participants With Pulmonary Interstitial Emphysema
Time frame: in the first 72 hours of life
Number of Participants With Abnormal Cranial Ultrasound Findings
Time frame: through study completion, an average of 4 months
Duration of Endotracheal Ventilation
Time frame: days through study completion, an average of 4 months
Duration of Non-invasive Ventilation
Time frame: days through study completion, an average of 4 months
Duration of Supplemental Oxygen Therapy
Time frame: days through study completion, an average of 4 months
Total Duration of Assisted Ventilation
Time frame: through study completion, an average of 4 months
Number of Participants With a Diagnosis of Bronchopulmonary Dysplasia
Time frame: at 36 weeks corrected gestational age
Neonatal Mortality
Time frame: from time of birth until discharge from hospital, up to 44 weeks corrected gestational age
Composite Outcome of Death or BPD
Time frame: BPD assessed at corrected gestational age of 36 weeks; death assessed from the time of birth until hospital discharge or 44 weeks corrected gestational age, whichever occurred first
Number of Participants With Retinopathy of Prematurity Requiring Treatment
Time frame: before hospital discharge, an average of 4 months
Number of Participants With a Diagnosis of Necrotizing Enterocolitis
Time frame: before hospital discharge, an average of 4 months
Number of Participants Requiring Fluid Boluses for Circulatory Support
Time frame: within the first 3 days of life
Number of Participants With Endotracheal Intubation in the NICU
Time frame: in the first 24 hours of life
Neonatal Mortality in the Delivery Room
Time frame: from time of birth until transfer to NICU
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18192329Wood FE, Morley CJ, Dawson JA, Davis PG. A respiratory function monitor improves mask ventilation. Arch Dis Child Fetal Neonatal Ed. 2008 Sep;93(5):F380-1. doi: 10.1136/adc.2007.120097. Epub 2008 Jan 11.
- Background: PubMed 19776023Schmolzer GM, Kamlin OC, Dawson JA, te Pas AB, Morley CJ, Davis PG. Respiratory monitoring of neonatal resuscitation. Arch Dis Child Fetal Neonatal Ed. 2010 Jul;95(4):F295-303. doi: 10.1136/adc.2009.165878. Epub 2009 Sep 22.
- Derived from this study: PubMed 34302924van Zanten HA, Kuypers KLAM, van Zwet EW, van Vonderen JJ, Kamlin COF, Springer L, Lista G, Cavigioli F, Vento M, Nunez-Ramiro A, Oberthuer A, Kribs A, Kuester H, Horn S, Weinberg DD, Foglia EE, Morley CJ, Davis PG, Te Pas AB. A multi-centre randomised controlled trial of respiratory function monitoring during stabilisation of very preterm infants at birth. Resuscitation. 2021 Oct;167:317-325. doi: 10.1016/j.resuscitation.2021.07.012. Epub 2021 Jul 22.
- Individual participant dataSharing planned: No
Related trials for Resuscitation
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
Not yet recruitingObservational study
Ultrasound-Calibrated Pulse Contour Cardiac Output Monitoring: Value and Accuracy in Hemodynamic Care
Sepsis, Circulatory Instability
Not yet recruiting
Compression-Only Versus Standard Basic Life Support Training in Nursing Students
Cardiopulmonary Resuscitation, Out-of-Hospital Cardiac Arrest
Not yet recruiting
Execution of Prehospital Transesophageal Echocardiography During Cardiopulmonary Resuscitation in Patients With Out-of-hospital Cardiac Arrest
Out-of-hospital Cardiac Arrest (OHCA)
Not yet recruiting
Deep-plane Facelift As A Staged Adjunct To Facial Reanimation : Functional And Aesthetic Outcomes in Comparison to Facial Reanimation Alone
Facial Palsy
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.
Arjan te Pas, MD principal investigator
Leiden University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New Life Box Respiratory Function Monitor in people with Resuscitation and Neonatal Prematurity, run by University of Pennsylvania 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 2 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: finished, as of the sponsor's last update on 22 Nov 2021. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jan 2021). 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?
Percentage of Positive-Pressure Ventilation Inflations Between 4 - 8 Mls/kg (time frame: the first 15 minutes of resuscitation). 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 NCT03256578, which also lists 3 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 22 Nov 2021.