Newborn MorbidityNCT04258722
Reducing Adverse Delivery Outcomes Through Teleneonatology: A Feasibility Study
A study testing Resuscitation Personnel in people with Newborn Morbidity, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
Teleneonatology, the use of audio-video communication to facilitate neonatal-perinatal care, may bridge the resuscitation quality gap by connecting centers with lower level care to experienced care providers. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Newborn Morbidity
- What is being tested?
- Resuscitation Personnel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2020to 30 Jan 2023
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria for experienced providers include at least 3 years of pediatric and/or neonatal training, having previously performed >10 endotracheal intubations, and may include neonatologists, pediatric fellows, and neonatal nurse practitioners. Inclusion criteria for trainees: previous exposure to NRP, an interval of > 3 months elapsing between previous NRP applications, and may include pediatric residents, family medicine residents, nurses, respiratory therapists, neonatal fellows, and neonatal attendings.
Who cannot join
- Does not meet inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Teleneonatology, the use of audio-video communication to facilitate neonatal-perinatal care, may bridge the resuscitation quality gap by connecting centers with lower level care to experienced care providers. Using randomized trial design, this investigation will compare teleneonatal resuscitation facilitated by a neonatologist to standard resuscitation within a simulated environment.
Read the detailed description
Multiple studies have evaluated telemedicine using simulation, but the level of evidence for the use of telemedicine to improve neonatal resuscitation is low.
In this investigation and within a simulated environment, pediatric interns and residents will resuscitate a simulated 25 week infant at delivery assisted by a simulated nurse and respiratory therapist. Participants will be randomized to resuscitation performed either with or without telemedicine facilitated by a neonatologist. The primary outcome will be time to effective ventilation with other secondary outcomes including metrics derived from the American Academy of Pediatrics Neonatal Resuscitation Program.
- Conditions
- Newborn Morbidity
- Being tested
- Resuscitation Personnel
- Keywords
- telemedicine, simulation, neonatal resuscitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resuscitation PersonnelOther
Type of resuscitation team
| Study group | Role | What they receive |
|---|---|---|
| Trainee + Teleneonatologist | Experimental | Trainee, teleneonatologist, nurse, and respiratory therapist will perform resuscitation Receives: Other: Resuscitation Personnel |
| Trainee | Active comparator | Trainee, nurse, and respiratory therapist will perform resuscitation. Receives: Other: Resuscitation Personnel |
What is being measured
The primary outcome is the main question the study is designed to answer.
No flow fraction
The proportion of time for which the mannequin received no effective compression (the number of seconds without effective chest compressions divided by the total number of seconds)
Measured: From start time of compression until 60 seconds have elapsed
Secondary outcomes (25)
Temperature regulation
Infant placed in polyethylene wrap with warming mattress and hat placed on head.
Measured: From baseline to 30 seconds
Time of first heart rate check (seconds)
The number of seconds elapsed at the time the heart rate was first checked either by stethoscope, palpation of umbilical stump, or by EKG lead.
Measured: From baseline until heart rate check up to 5 minutes
Heart rate check compliance
HR was checked within 60 seconds after birth.
Measured: From baseline to 60 seconds up to 5 minutes
Time of bag mask ventilation (seconds)
The number of seconds elapsed at the time the mask was first applied to the infant's face.
Measured: From baseline to bag mask placement up to 5 minutes
Bag mask ventilation compliance
Mask was applied to the infant's face at 60 seconds after birth.
Measured: From baseline to 60 seconds
Time of sat probe placement (seconds)
The number of seconds elapsed at the time the oxygen saturation probe was placed.
Measured: From baseline to probe placement up to 5 minutes
Sat probe placement compliance
Sat probe placed at 60 seconds after birth.
Measured: From baseline to 60 seconds
Time of increase in FiO2 (seconds)
The number of seconds elapsed at the time the amount of oxygen administered was increased.
Measured: From simulation start to time of FiO2 increase up to 5 minutes
MR SOPA Performance: Mask adjustment
Mask was adjusted on the infant's face
Measured: From start of bag mask ventilation to 2 minutes
MR SOPA Performance: Reposition airway
infant's neck was adjusted
Measured: From start of bag mask ventilation to 2 minutes
MR SOPA Performance: Suction mouth
infant's mouth was suctioned
Measured: From start of bag mask ventilation to 2 minutes
MR SOPA Performance: Open mouth
infant's mouth was opened
Measured: From start of bag mask ventilation to 2 minutes
MR SOPA Performance: Increased pressure
pressure on bag mask was increased
Measured: From start of bag mask ventilation to 2 minutes
MR SOPA Performance: Placed advanced airway
endotracheal tube was placed
Measured: From start of bag mask ventilation to 2 minutes
MR SOPA performed in correct sequence
corrective measures were performed in this sequence
Measured: From start of bag mask ventilation to 2 minutes
MR SOPA measures all performed
each corrective measure was performed
Measured: From start of bag mask ventilation to 2 minutes
Number of steps correctly performed
The number of steps correctly performed during the resuscitation
Measured: From start of bag mask ventilation to 2 minutes
Time to effective ventilation (seconds)
The number of seconds elapsed at the time the mannequin had visible chest rise
Measured: From time of bag mask placement until chest rise up to 5 minutes
Time to first compression (seconds)
The number of seconds elapsed at the time the first chest compression was performed
Measured: From baseline until first compression up to 5 minutes
Correct hand position
Hands positioned with either two fingers on the mannequin's sternum or thumbs over the sternum with hands encircling the chest
Measured: From baseline until first compression up to 5 minutes
Compression depth compliance
Compressions given at 1/3 of the infant's chest depth
Measured: From baseline until first compression up to 5 minutes
Compression synchronization compliance
Synchronization with bag mask ventilation with a rate of 3 compressions: 1 ventilation
Measured: From start time of compression until 60 seconds have elapsed
Compression rate per minute
Number of compressions within 10 seconds multiplied by 6
Measured: From start time of compression until 10 seconds have elapsed
No blow fraction
The proportion of time for which the mannequin received no effective ventilation (the number of seconds without effective ventilation divided by the total number of seconds)
Measured: From baseline to 10 minutes
Time to effective ventilation (seconds)
The number of seconds elapsed at the time the mannequin is intubated and ventilated
Measured: From baseline to time of first ventilated breath with an endotracheal tube up to 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 Feb 2020
- Study start30 Nov 2020
- Primary completion30 Jan 2023
- Study completion30 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Newborn MorbidityStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel Gentle, University of Alabama at Birmingham
- Investigators
- Samuel Gentle, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04258722
- Sponsor's protocol ID
- IRB-300004483
- Status last verified
- Dec 2023
- First submitted
- 4 Feb 2020
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gentle SJ, Trulove SG, Rockwell N, Rutledge C, Gaither S, Norwood C, Wallace E, Carlo WA, Tofil NM. Teleneonatal or routine resuscitation in extremely preterm infants: a randomized simulation trial. Pediatr Res. 2025 Jan;97(1):222-228. doi: 10.1038/s41390-024-03545-1. Epub 2024 Sep 28.
PubMed 39341942
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Adverse Delivery Outcomes Through Teleneonatology: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04258722
- Acronym / sponsor ID
- IRB-300004483
- Conditions
- Newborn Morbidity
- Keywords
- telemedicine, simulation, neonatal resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 30 Nov 2020 (actual)
- Primary completion
- 30 Jan 2023 (actual)
- Study completion
- 30 Jan 2023 (actual)
- First posted
- 6 Feb 2020 (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.
Teleneonatology, the use of audio-video communication to facilitate neonatal-perinatal care, may bridge the resuscitation quality gap by connecting centers with lower level care to experienced care providers. Using randomized trial design, this investigation will compare teleneonatal resuscitation facilitated by a neonatologist to standard resuscitation within a simulated environment.
Detailed description
Multiple studies have evaluated telemedicine using simulation, but the level of evidence for the use of telemedicine to improve neonatal resuscitation is low.
In this investigation and within a simulated environment, pediatric interns and residents will resuscitate a simulated 25 week infant at delivery assisted by a simulated nurse and respiratory therapist. Participants will be randomized to resuscitation performed either with or without telemedicine facilitated by a neonatologist. The primary outcome will be time to effective ventilation with other secondary outcomes including metrics derived from the American Academy of Pediatrics Neonatal Resuscitation Program.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Trainee + Teleneonatologist | Experimental | Other: Resuscitation PersonnelTrainee, teleneonatologist, nurse, and respiratory therapist will perform resuscitation |
| Trainee | Active comparator | Other: Resuscitation PersonnelTrainee, nurse, and respiratory therapist will perform resuscitation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria for experienced providers include at least 3 years of pediatric and/or neonatal training, having previously performed >10 endotracheal intubations, and may include neonatologists, pediatric fellows, and neonatal nurse practitioners. Inclusion criteria for trainees: previous exposure to NRP, an interval of > 3 months elapsing between previous NRP applications, and may include pediatric residents, family medicine residents, nurses, respiratory therapists, neonatal fellows, and neonatal attendings.
Key exclusion criteria (1 listed)
- Does not meet inclusion criteria
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 |
|---|---|---|
| Resuscitation PersonnelType of resuscitation team | Other | Trainee, Trainee + Teleneonatologist |
Primary outcome
No flow fraction
Time frame: From start time of compression until 60 seconds have elapsed
The proportion of time for which the mannequin received no effective compression (the number of seconds without effective chest compressions divided by the total number of seconds)
25 secondary outcomes
Temperature regulation
Time frame: From baseline to 30 seconds
Time of first heart rate check (seconds)
Time frame: From baseline until heart rate check up to 5 minutes
Heart rate check compliance
Time frame: From baseline to 60 seconds up to 5 minutes
Time of bag mask ventilation (seconds)
Time frame: From baseline to bag mask placement up to 5 minutes
Bag mask ventilation compliance
Time frame: From baseline to 60 seconds
Time of sat probe placement (seconds)
Time frame: From baseline to probe placement up to 5 minutes
Sat probe placement compliance
Time frame: From baseline to 60 seconds
Time of increase in FiO2 (seconds)
Time frame: From simulation start to time of FiO2 increase up to 5 minutes
MR SOPA Performance: Mask adjustment
Time frame: From start of bag mask ventilation to 2 minutes
MR SOPA Performance: Reposition airway
Time frame: From start of bag mask ventilation to 2 minutes
MR SOPA Performance: Suction mouth
Time frame: From start of bag mask ventilation to 2 minutes
MR SOPA Performance: Open mouth
Time frame: From start of bag mask ventilation to 2 minutes
MR SOPA Performance: Increased pressure
Time frame: From start of bag mask ventilation to 2 minutes
MR SOPA Performance: Placed advanced airway
Time frame: From start of bag mask ventilation to 2 minutes
MR SOPA performed in correct sequence
Time frame: From start of bag mask ventilation to 2 minutes
MR SOPA measures all performed
Time frame: From start of bag mask ventilation to 2 minutes
Number of steps correctly performed
Time frame: From start of bag mask ventilation to 2 minutes
Time to effective ventilation (seconds)
Time frame: From time of bag mask placement until chest rise up to 5 minutes
Time to first compression (seconds)
Time frame: From baseline until first compression up to 5 minutes
Correct hand position
Time frame: From baseline until first compression up to 5 minutes
Compression depth compliance
Time frame: From baseline until first compression up to 5 minutes
Compression synchronization compliance
Time frame: From start time of compression until 60 seconds have elapsed
Compression rate per minute
Time frame: From start time of compression until 10 seconds have elapsed
No blow fraction
Time frame: From baseline to 10 minutes
Time to effective ventilation (seconds)
Time frame: From baseline to time of first ventilated breath with an endotracheal tube up to 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- Derived from this study: PubMed 39341942Gentle SJ, Trulove SG, Rockwell N, Rutledge C, Gaither S, Norwood C, Wallace E, Carlo WA, Tofil NM. Teleneonatal or routine resuscitation in extremely preterm infants: a randomized simulation trial. Pediatr Res. 2025 Jan;97(1):222-228. doi: 10.1038/s41390-024-03545-1. Epub 2024 Sep 28.
- 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.
Samuel Gentle, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resuscitation Personnel in people with Newborn Morbidity, run by University of Alabama at Birmingham 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 1 inclusion and 1 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 Dec 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
No flow fraction (time frame: From start time of compression until 60 seconds have elapsed). 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 NCT04258722, which also lists 1 linked publication.
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 Dec 2023.