Premature InfantGE-EKGNCT04587934
Time to Accurate Heart Rate on Neonatal Outcomes
A study testing iRes Warmer with ResusView and iRes Warmer without ResusView in people with Premature Infant and Extremely Low Birth Weight, run by Sharp HealthCare at 1 site in United States.
Trial summary
The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g. Cardiopulmonary resuscitation or breathing assistance) of premature newborns (23 to 32+6 weeks gestation). Read more about this study
- Who is it for?
- Ages 23 to 32 weeks
- Conditions the study is for
- Premature Infant, Extremely Low Birth Weight, Extreme Prematurity
- What is being tested?
- iRes Warmer with ResusView and iRes Warmer without ResusView
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 10 Dec 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 23 to 32 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants who are delivered to mothers over the age of 16 years of age
- Infants delivered at 23+0 to 32+6 weeks estimated gestational age based on the best obstetric estimate at the time of delivery.
- Infants without known congenital malformations prior to delivery
- Antenatal consent
Who cannot join
- Infants who are delivered to mothers under the age of 16 years of age
- Known congenital anomalies of newborn prior to delivery
- Cardiac defects other than small Ventricular septum defect and Patent ductus arteriosus
- Multiples
- Declined consent
- iRes Warmer with ResusView not available at time of delivery
Trial locations and contacts
1 site in 1 country.
United States1 site
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, 92123
About this study
The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g. Cardiopulmonary resuscitation or breathing assistance) of premature newborns (23 to 32+6 weeks gestation).
Read the detailed description
This is a prospective interventional randomized control trial. Infants born between 23+0 and 32+6 estimated gestational age will be randomized using a computer generate allocation sequence stratified by gestational age. Randomization cards will be placed in opaque envelopes. For the intervention group, the care team will use the Panda iRes Warmer with ResusView Bed during resuscitation interventions in the first 10 minutes of life. During use of the iRes-warmer, standard nursing care of an infant on a radiant warmer will be followed. Participants assigned to the control group will receive interventions using the same model Panda bed without ResusView. There is no minimum time for monitoring, and the maximum time depends on clinical determination for use of heart rate feature for each resuscitation event. Data including the infant's gestational age, Electrocardiogram lead type and activities that occurred during resuscitation will be recorded for the first 10 minutes of life.
- Being tested
- iRes Warmer with ResusView, iRes Warmer without ResusView
- Keywords
- electrocardiogram, Neonatal Resuscitation, resuscitation of premature infants
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iRes Warmer with ResusViewDevice
Also called Panda Bed with ECG Feature
Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age
iRes Warmer without ResusViewOther
Also called Standard of Care
Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age
| Study group | Role | What they receive |
|---|---|---|
| iRes Warmer with ResusView | Experimental | iRes Warmer with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation. Receives: Device: iRes Warmer with ResusView |
| iRes Warmer without ResusView | Active comparator | An external non-experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation. Receives: Other: iRes Warmer without ResusView |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Heart Rate Display in iRes Warmer With Resusview
Measure time from birth to heart rate displayed on monitor following lead placement
Measured: Birth to 10 minutes of life
Secondary outcomes (3)
Time to First Change in Fraction of Inspired Oxygen
Measure time from birth to first increase or decrease in fraction of inspired oxygen from ECG lead placement
Measured: Birth to 10 minutes of life
Time to First Change in Airway Pressure
Measure time from birth to first increase or decrease in airway pressure from ECG lead placement
Measured: Birth to 10 minutes of life
Time to Initiation of Positive Pressure Ventilation (PPV)
Measure time from birth to start of PPV following first heart rate display
Measured: Birth to 10 minutes of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Feb 2021
- Primary completion30 Jun 2021
- Study completion10 Dec 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 (4)Papers the sponsor has linked to this study.
- Other trials for Premature InfantStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sharp HealthCare
- Sponsor type
- University, hospital or other
- Collaborators
- GE Healthcare, Sharp Mary Birch Hospital for Women & Newborns
- Responsible party
- Sponsor
- Investigators
- Anup Katheria, MD, Principal investigator, Sharp HealthCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04587934
- Sponsor's protocol ID
- GE-EKG
- Acronym
- GE-EKG
- Status last verified
- Dec 2023
- First submitted
- 2 Oct 2020
- Last updated
- 10 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data, particularly data that underlie the results reported in this article after deidentification will be available with other researchers, including data dictionaries for meta-analysis.
Publications
Katheria A, Arnell K, Brown M, Hassen K, Maldonado M, Rich W, Finer N. A pilot randomized controlled trial of EKG for neonatal resuscitation. PLoS One. 2017 Nov 3;12(11):e0187730. doi: 10.1371/journal.pone.0187730. eCollection 2017.
PubMed 29099872Johnson PA, Schmolzer GM. Heart Rate Assessment during Neonatal Resuscitation. Healthcare (Basel). 2020 Feb 23;8(1):43. doi: 10.3390/healthcare8010043.
PubMed 32102255Neonatal Resuscitation. Vol. 7th edition. 2016, Elk Grove Village, IL: American Academy of Pediatrics.
Katheria AC, Morales A, Shashank S, Rich WD, Finer NN. A Pilot Randomized Trial of Heart Rate Monitoring Using Conventional Versus a New Electrocardiogram Algorithm during Neonatal Resuscitation at Birth. J Pediatr. 2022 Mar;242:245-247.e1. doi: 10.1016/j.jpeds.2021.10.037. Epub 2021 Oct 27.
PubMed 34715091
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time to Accurate Heart Rate on Neonatal Outcomes
- ClinicalTrials.gov ID
- NCT04587934
- Acronym / sponsor ID
- GE-EKG / GE-EKG
- Keywords
- electrocardiogram, Neonatal Resuscitation, resuscitation of premature infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Sharp HealthCareUniversity, hospital or other
- Collaborators
- GE Healthcare, Sharp Mary Birch Hospital for Women & Newborns
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 10 Dec 2021 (actual)
- First posted
- 14 Oct 2020 (actual)
- Results
- Posted 10 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this trial is to compare the time to first heart rate displayed for iRes Warmer with ResusView and using iRes Warmer without ResusView when used in the resuscitation (e.g. Cardiopulmonary resuscitation or breathing assistance) of premature newborns (23 to 32+6 weeks gestation).
Detailed description
This is a prospective interventional randomized control trial. Infants born between 23+0 and 32+6 estimated gestational age will be randomized using a computer generate allocation sequence stratified by gestational age. Randomization cards will be placed in opaque envelopes. For the intervention group, the care team will use the Panda iRes Warmer with ResusView Bed during resuscitation interventions in the first 10 minutes of life. During use of the iRes-warmer, standard nursing care of an infant on a radiant warmer will be followed. Participants assigned to the control group will receive interventions using the same model Panda bed without ResusView. There is no minimum time for monitoring, and the maximum time depends on clinical determination for use of heart rate feature for each resuscitation event. Data including the infant's gestational age, Electrocardiogram lead type and activities that occurred during resuscitation will be recorded for the first 10 minutes of life.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iRes Warmer with ResusView | Experimental | Device: iRes Warmer with ResusViewiRes Warmer with ResusView program with experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation. |
| iRes Warmer without ResusView | Active comparator | Other: iRes Warmer without ResusViewAn external non-experimental electrocardiogram monitor will be used for heart rate monitoring in the first 10 minutes of life during routine care and and/or neonatal resuscitation. |
Who may qualify
- Ages
- 23 to 32 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Infants who are delivered to mothers over the age of 16 years of age
- Infants delivered at 23+0 to 32+6 weeks estimated gestational age based on the best obstetric estimate at the time of delivery.
- Infants without known congenital malformations prior to delivery
- Antenatal consent
Key exclusion criteria (6 listed)
- Infants who are delivered to mothers under the age of 16 years of age
- Known congenital anomalies of newborn prior to delivery
- Cardiac defects other than small Ventricular septum defect and Patent ductus arteriosus
- Multiples
- Declined 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 |
|---|---|---|
| iRes Warmer with ResusViewAlso: Panda Bed with ECG FeatureRapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age | Device | iRes Warmer with ResusView |
| iRes Warmer without ResusViewAlso: Standard of CareElectrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age | Other | iRes Warmer without ResusView |
Primary outcome
Time to Heart Rate Display in iRes Warmer With Resusview
Time frame: Birth to 10 minutes of life
Measure time from birth to heart rate displayed on monitor following lead placement
3 secondary outcomes
Time to First Change in Fraction of Inspired Oxygen
Time frame: Birth to 10 minutes of life
Time to First Change in Airway Pressure
Time frame: Birth to 10 minutes of life
Time to Initiation of Positive Pressure Ventilation (PPV)
Time frame: Birth to 10 minutes of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29099872Katheria A, Arnell K, Brown M, Hassen K, Maldonado M, Rich W, Finer N. A pilot randomized controlled trial of EKG for neonatal resuscitation. PLoS One. 2017 Nov 3;12(11):e0187730. doi: 10.1371/journal.pone.0187730. eCollection 2017.
- Background: PubMed 32102255Johnson PA, Schmolzer GM. Heart Rate Assessment during Neonatal Resuscitation. Healthcare (Basel). 2020 Feb 23;8(1):43. doi: 10.3390/healthcare8010043.
- BackgroundNeonatal Resuscitation. Vol. 7th edition. 2016, Elk Grove Village, IL: American Academy of Pediatrics.
- Derived from this study: PubMed 34715091Katheria AC, Morales A, Shashank S, Rich WD, Finer NN. A Pilot Randomized Trial of Heart Rate Monitoring Using Conventional Versus a New Electrocardiogram Algorithm during Neonatal Resuscitation at Birth. J Pediatr. 2022 Mar;242:245-247.e1. doi: 10.1016/j.jpeds.2021.10.037. Epub 2021 Oct 27.
- Individual participant dataSharing planned: Yes. Individual participant data, particularly data that underlie the results reported in this article after deidentification will be available with other researchers, including data dictionaries for meta-analysis.
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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.
Anup Katheria, MD principal investigator
Sharp HealthCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iRes Warmer with ResusView and iRes Warmer without ResusView in people with Premature Infant and Extremely Low Birth Weight, run by Sharp HealthCare 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 6 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 10 Jan 2024. 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 10 Jan 2024). 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?
Time to Heart Rate Display in iRes Warmer With Resusview (time frame: Birth to 10 minutes of life). 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 NCT04587934, which also lists 4 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 10 Jan 2024.