Neonatal Respiratory DistressTESTNCT06572033
Transference of Established Simulated Skills (TEST) Trial
An observational study of Neonatal Respiratory Distress, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
This study aims to determine if skills learned in the simulation lab, specifically in managing mask leak during positive pressure ventilation (PPV), translate effectively to the delivery room. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Neonatal Respiratory Distress
- What is being tested?
- Simulation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2024to 29 Jun 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 1. Respiratory Therapists (RTs): Demographics: This group includes Respiratory Therapists employed in the Neonatal Intensive Care Unit (NICU) at Parkland Hospital. Participants have varying levels of experience, ranging from newly certified RTs to those with extensive experience in neonatal care. 2. Newborn Infants: Demographics: This group includes newborn infants requiring positive pressure ventilation (PPV) immediately after birth in the delivery room. Infants included in the study will vary in gestational age, birth weight, and clinical condition, representing a broad range of neonatal resuscitation scenarios.
Who may be able to join
- Respiratory Therapists who are employed in the Neonatal Intensive Care Unit (NICU) at Parkland Hospital.
- RTs who actively participate in neonatal deliveries.
- Newborn infants who require positive pressure ventilation (PPV) immediately after birth in the delivery room.
- Infants of various gestational ages and birth weights, representing a broad spectrum of neonatal resuscitation scenarios.
Who cannot join
- Respiratory Therapists classified as "float" RTs, meaning those who do not have a permanent assignment in the NICU.
- RTs who intend to leave the institution within the upcoming year.
- Newborns who do not require PPV after birth.
- Infants for whom the use of the respiratory function monitor (RFM) is not feasible due to medical or technical reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transference of Established Simulated Skills (TEST) Trial: Tracking Transference of Positive Pressure Ventilation Skills From Simulation to Delivery Room.
This study aims to determine if skills learned in the simulation lab, specifically in managing mask leak during positive pressure ventilation (PPV), translate effectively to the delivery room. By comparing the performance of healthcare providers on mannequins in the lab to their performance on newborns in the delivery room, the study seeks to establish a Ventilation Performance Score (VPS) based on data from a respiratory function monitor. The primary hypothesis is that a provider's ability to minimize mask leak on a mannequin correlates with their ability to do so with a newborn. The prospective observational TEST Trial will use the Monivent Neo100 to collect and analyze PPV data, comparing key parameters like mask leak and VQS between the two settings to assess correlations. Secondary analysis will explore individual aspects of PPV, such as PIP, PEEP, and eVT.
Read the detailed description
Objectives: The aim of this study is to establish evidence that supports the transfer of skills learned in the simulation lab to the delivery room. The objective of this study is to compare the performance of positive pressure ventilation (PPV) in the simulation lab to the performance of the same individual in the delivery room. Our goal is to establish a comparison between parameters measured on the simulator and those obtained from real newborn infants, specifically looking at mask leak. Our approach hopes to develop a ventilation performance score (VPS) in the process that will be based on objective data collected using a respiratory function monitor (RFM). The primary hypothesis is that the quality of a qualified provider's ability to circumvent mask leak on a mannequin correlates with the ability of the same provider to circumvent mask leak observed on a newborn infant.
Design and outcomes: TEST Trial is a prospective observational study to assess differences in the participants ability to avoid mask leak while performing PPV and in the process allow the investigators to develop a ventilatory performance score in the simulation lab and the delivery room. We will use the RFM Monivent Neo100 to gather PPV data in both the simulation lab from the mannequins and newborns in the delivery room. The study will compare mask leak as well as VPS in the simulation room to mask leak and VPS in the delivery room to assess for correlations. In addition, the investigators will conduct secondary analysis on each individual domain of positive pressure ventilation, such as PIP, PEEP, eVT, etc.
- Conditions
- Neonatal Respiratory Distress
- Being tested
- Simulation
- Medical subject headings
- Pulmonary Atelectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationBehavioural
Observational study with simulations.
| Study group | Role | What they receive |
|---|---|---|
| Respiratory Therapists | This cohort consists of respiratory therapists (RTs) who are actively involved in both simulation-based training sessions and actual neonatal deliveries. Participants will have varying levels of experience, from newly qualified to seasoned professionals. During the study, RTs will perform positive pressure ventilation (PPV) on both neonatal mannequins in the simulation lab and on newborns in the delivery room. Their performance will be measured using a respiratory function monitor (RFM), focusing on parameters such as mask leak, peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), and exhaled tidal volume (eVT). The goal is to assess the transferability of their skills from simulation to real-life scenarios. Receives: Behavioral: Simulation | |
| Newborn Infants | This cohort consists of respiratory therapists (RTs) who are actively involved in both simulation-based training sessions and actual neonatal deliveries. Participants will have varying levels of experience, from newly qualified to seasoned professionals. During the study, RTs will perform positive pressure ventilation (PPV) on both neonatal mannequins in the simulation lab and on newborns in the delivery room. Their performance will be measured using a respiratory function monitor (RFM), focusing on parameters such as mask leak, peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), and exhaled tidal volume (eVT). The goal is to assess the transferability of their skills from simulation to real-life scenarios. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of mask leak performance
Correlation between the percentage of mask leak observed during positive pressure ventilation (PPV) on a mannequin in the simulation laboratory and the percentage of mask leak observed during PPV on a newborn infant in the delivery room.
Measured: 1 year
Secondary outcomes (2)
Correlation of Ventilation Performance Score (VPS)
Correlation of Ventilation Performance Score (VPS) between the simulation lab and the delivery room.
Measured: 1 year
Correlation of submetrics of VPS
Correlation of submetrics of VPS (such as TVe, mask seal, PIP, PEEP, etc.) between the simulation lab and the delivery room.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start12 Aug 2024
- Primary completion29 Dec 2025
- Study completion29 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal Respiratory DistressStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vishal Kapadia, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06572033
- Sponsor's protocol ID
- STU 2023-1099
- Acronym
- TEST
- Status last verified
- Jul 2025
- First submitted
- 23 Aug 2024
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transference of Established Simulated Skills (TEST) Trial: Tracking Transference of Positive Pressure Ventilation Skills From Simulation to Delivery Room.
- ClinicalTrials.gov ID
- NCT06572033
- Acronym / sponsor ID
- TEST / STU 2023-1099
- Conditions
- Neonatal Respiratory Distress
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 12 Aug 2024 (actual)
- Primary completion
- 29 Dec 2025 (actual)
- Study completion
- 29 Jun 2026 (estimated)
- First posted
- 26 Aug 2024 (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.
This study aims to determine if skills learned in the simulation lab, specifically in managing mask leak during positive pressure ventilation (PPV), translate effectively to the delivery room. By comparing the performance of healthcare providers on mannequins in the lab to their performance on newborns in the delivery room, the study seeks to establish a Ventilation Performance Score (VPS) based on data from a respiratory function monitor. The primary hypothesis is that a provider's ability to minimize mask leak on a mannequin correlates with their ability to do so with a newborn. The prospective observational TEST Trial will use the Monivent Neo100 to collect and analyze PPV data, comparing key parameters like mask leak and VQS between the two settings to assess correlations. Secondary analysis will explore individual aspects of PPV, such as PIP, PEEP, and eVT.
Detailed description
Objectives: The aim of this study is to establish evidence that supports the transfer of skills learned in the simulation lab to the delivery room. The objective of this study is to compare the performance of positive pressure ventilation (PPV) in the simulation lab to the performance of the same individual in the delivery room. Our goal is to establish a comparison between parameters measured on the simulator and those obtained from real newborn infants, specifically looking at mask leak. Our approach hopes to develop a ventilation performance score (VPS) in the process that will be based on objective data collected using a respiratory function monitor (RFM). The primary hypothesis is that the quality of a qualified provider's ability to circumvent mask leak on a mannequin correlates with the ability of the same provider to circumvent mask leak observed on a newborn infant.
Design and outcomes: TEST Trial is a prospective observational study to assess differences in the participants ability to avoid mask leak while performing PPV and in the process allow the investigators to develop a ventilatory performance score in the simulation lab and the delivery room. We will use the RFM Monivent Neo100 to gather PPV data in both the simulation lab from the mannequins and newborns in the delivery room. The study will compare mask leak as well as VPS in the simulation room to mask leak and VPS in the delivery room to assess for correlations. In addition, the investigators will conduct secondary analysis on each individual domain of positive pressure ventilation, such as PIP, PEEP, eVT, etc.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Respiratory Therapists | – | Behavioral: SimulationThis cohort consists of respiratory therapists (RTs) who are actively involved in both simulation-based training sessions and actual neonatal deliveries. Participants will have varying levels of experience, from newly qualified to seasoned professionals. During the study, RTs will perform positive pressure ventilation (PPV) on both neonatal mannequins in the simulation lab and on newborns in the delivery room. Their performance will be measured using a respiratory function monitor (RFM), focusing on parameters such as mask leak, peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), and exhaled tidal volume (eVT). The goal is to assess the transferability of their skills from simulation to real-life scenarios. |
| Newborn Infants | – | –This cohort consists of respiratory therapists (RTs) who are actively involved in both simulation-based training sessions and actual neonatal deliveries. Participants will have varying levels of experience, from newly qualified to seasoned professionals. During the study, RTs will perform positive pressure ventilation (PPV) on both neonatal mannequins in the simulation lab and on newborns in the delivery room. Their performance will be measured using a respiratory function monitor (RFM), focusing on parameters such as mask leak, peak inspiratory pressure (PIP), positive end-expiratory pressure (PEEP), and exhaled tidal volume (eVT). The goal is to assess the transferability of their skills from simulation to real-life scenarios. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 1. Respiratory Therapists (RTs): Demographics: This group includes Respiratory Therapists employed in the Neonatal Intensive Care Unit (NICU) at Parkland Hospital. Participants have varying levels of experience, ranging from newly certified RTs to those with extensive experience in neonatal care. 2. Newborn Infants: Demographics: This group includes newborn infants requiring positive pressure ventilation (PPV) immediately after birth in the delivery room. Infants included in the study will vary in gestational age, birth weight, and clinical condition, representing a broad range of neonatal resuscitation scenarios.
Key inclusion criteria (4 listed)
- Respiratory Therapists who are employed in the Neonatal Intensive Care Unit (NICU) at Parkland Hospital.
- RTs who actively participate in neonatal deliveries.
- Newborn infants who require positive pressure ventilation (PPV) immediately after birth in the delivery room.
- Infants of various gestational ages and birth weights, representing a broad spectrum of neonatal resuscitation scenarios.
Key exclusion criteria (4 listed)
- Respiratory Therapists classified as "float" RTs, meaning those who do not have a permanent assignment in the NICU.
- RTs who intend to leave the institution within the upcoming year.
- Newborns who do not require PPV after birth.
- Infants for whom the use of the respiratory function monitor (RFM) is not feasible due to medical or technical reasons.
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 |
|---|---|---|
| SimulationObservational study with simulations. | Behavioural | Respiratory Therapists |
Primary outcome
Correlation of mask leak performance
Time frame: 1 year
Correlation between the percentage of mask leak observed during positive pressure ventilation (PPV) on a mannequin in the simulation laboratory and the percentage of mask leak observed during PPV on a newborn infant in the delivery room.
2 secondary outcomes
Correlation of Ventilation Performance Score (VPS)
Time frame: 1 year
Correlation of submetrics of VPS
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Respiratory Distress, run by University of Texas Southwestern Medical Center 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 4 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: under way, not looking for participants, as of the sponsor's last update on 25 Mar 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Correlation of mask leak performance (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Mar 2026.