Delivery Room ResuscitationNCT01381068
Quantitative End Tidal CO2 Monitoring in the Delivery Room (DR)
A study testing End tidal CO2 monitor in people with Delivery Room Resuscitation, run by Neil Finer at 1 site in United States.
Trial summary
This is a trial evaluating the use of an end tidal CO2 monitor during ventilation in the delivery room. The use of the monitor is compared with clinical assessment of ventilation. The hypothesis is that using the monitor would results in a decrease in the incidence of hypo- or hypercapnia on admission to the NICU. Read more about this study
- Who is it for?
- Ages Up to 15 minutes
- Conditions the study is for
- Delivery Room Resuscitation
- What is being tested?
- End tidal CO2 monitor
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Sep 2011
- 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 Up to 15 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Need for ventilation in the delivery room
Who cannot join
- Tracheal suctioning for meconium
- Congenital Diaphragmatic Hernia
- Suspected hypoplasia of the lungs
- Oligohydramnios <28 weeks gestation or AFI<5
- Known or suspected airway anomaly
- Mother not speaking English or Spanish
- Refusal of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative End Tidal CO2 Monitoring in the Delivery Room: Can we Prevent Hypo/Hypercapnia Upon Admission to the NICU?
This is a trial evaluating the use of an end tidal CO2 monitor during ventilation in the delivery room. The use of the monitor is compared with clinical assessment of ventilation. The hypothesis is that using the monitor would results in a decrease in the incidence of hypo- or hypercapnia on admission to the NICU.
- Conditions
- Delivery Room Resuscitation
- Being tested
- End tidal CO2 monitor
- Keywords
- ventilation, end tidal carbon dioxide, hypercapnia, hypocapnia, positive pressure ventilation, neonates, delivery room resuscitation
- Medical subject headings
- Respiratory Aspiration, Hypercapnia, Hypocapnia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
End tidal CO2 monitorDevice
Also called NICO 2 Respiratory Profile Monitor (Respironics, Inc.)
The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.
| Study group | Role | What they receive |
|---|---|---|
| Monitored Arm | Experimental | The end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55. Receives: Device: End tidal CO2 monitor |
| Control Arm | Placebo comparator | The end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment. Receives: Device: End tidal CO2 monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCO2 Level Outside of Desired Range (40-60 mmHg)
This outcome will be obtained from the first available blood gas after admission to the NICU.
Measured: Admission to NICU, approximately 1 hour of life
Secondary outcomes (6)
End Tidal CO2 Levels
The EtCO2 levels from the last 5 breaths of the DR resuscitation will be averaged to determine this outcome.
Measured: At the conclusion of resuscitation, approximately 15 minutes of life.
Duration of Ventilation
The number of days on the ventilator during the entire hospital course will be counted for this outcome.
Measured: Duration of the hospital course, approximately 2-3 months
Oxygen Use at 36 Weeks
This outcome will be counted as yes if the infant is receiving oxygen at 36 weeks adjusted age.
Measured: Hospital course, approximately 2-3 months
Incidence of Pneumothorax/Airleak
This outcome will be counted as yes if any pneumothorax or airleak is noted on any chest xray during the hospitalization.
Measured: Hospital course, approximately 2-3 months
Number of Patients Ventilated on NICU Admission
At the time of NICU admission directly after the DR resuscitation the number of patients ventilated will be reported per group
Measured: On NICU admission, approximately 15 minutes of life
Systemic Blood Flow - as Measured by Supervior Vena Cava (SVC) Flow
An echocardiogram performed within the first 12 hours of life will measure supervior vena cava (SVC) flow.
Measured: Within 12 hours of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2011 (estimated)
- Study startOct 2009
- Primary completionMay 2011
- Study completionSep 2011
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.
- Other trials for Delivery Room 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neil Finer
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Neil Finer, University of California, San Diego
- Investigators
- Tina A Leone, MD, Principal investigator, UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01381068
- Sponsor's protocol ID
- 090780
- Status last verified
- Oct 2019
- First submitted
- 21 Jun 2011
- Last updated
- 17 Dec 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative End Tidal CO2 Monitoring in the Delivery Room: Can we Prevent Hypo/Hypercapnia Upon Admission to the NICU?
- ClinicalTrials.gov ID
- NCT01381068
- Acronym / sponsor ID
- 090780
- Conditions
- Delivery Room Resuscitation
- Keywords
- ventilation, end tidal carbon dioxide, hypercapnia, hypocapnia, positive pressure ventilation, neonates, delivery room resuscitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Neil FinerUniversity, hospital or other
- Study start
- Oct 2009 (actual)
- Primary completion
- May 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 27 Jun 2011 (estimated)
- Results
- Posted 17 Dec 2019
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 trial evaluating the use of an end tidal CO2 monitor during ventilation in the delivery room. The use of the monitor is compared with clinical assessment of ventilation. The hypothesis is that using the monitor would results in a decrease in the incidence of hypo- or hypercapnia on admission to the NICU.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Monitored Arm | Experimental | Device: End tidal CO2 monitorThe end tidal CO2 sensor is placed in the respiratory circuit and the monitor is visible to the resuscitation team. The resuscitation team is instructed to adjust ventilation to keep EtCO2 levels between 40-55. |
| Control Arm | Placebo comparator | Device: End tidal CO2 monitorThe end tidal CO2 sensor is placed in th respiratory circuit. The monitor is covered so the resuscitation team can not see the display. The resuscitation team is instructed to provide ventilation according to clinical judgment. |
Who may qualify
- Ages
- Up to 15 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Need for ventilation in the delivery room
Key exclusion criteria (7 listed)
- Tracheal suctioning for meconium
- Congenital Diaphragmatic Hernia
- Suspected hypoplasia of the lungs
- Oligohydramnios <28 weeks gestation or AFI<5
- Known or suspected airway anomaly
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 |
|---|---|---|
| End tidal CO2 monitorAlso: NICO 2 Respiratory Profile Monitor (Respironics, Inc.)The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms. | Device | Control Arm, Monitored Arm |
Primary outcome
PCO2 Level Outside of Desired Range (40-60 mmHg)
Time frame: Admission to NICU, approximately 1 hour of life
This outcome will be obtained from the first available blood gas after admission to the NICU.
6 secondary outcomes
End Tidal CO2 Levels
Time frame: At the conclusion of resuscitation, approximately 15 minutes of life.
Duration of Ventilation
Time frame: Duration of the hospital course, approximately 2-3 months
Oxygen Use at 36 Weeks
Time frame: Hospital course, approximately 2-3 months
Incidence of Pneumothorax/Airleak
Time frame: Hospital course, approximately 2-3 months
Number of Patients Ventilated on NICU Admission
Time frame: On NICU admission, approximately 15 minutes of life
Systemic Blood Flow - as Measured by Supervior Vena Cava (SVC) Flow
Time frame: Within 12 hours of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Delivery Room Resuscitation
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Recruiting
Supraglottic Airway for Resuscitation Trial
Neonatal Resuscitation, Delivery Room Resuscitation
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.
Tina A Leone, MD principal investigator
UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing End tidal CO2 monitor in people with Delivery Room Resuscitation, run by Neil Finer 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 7 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 17 Dec 2019. 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. Some participants in this study may receive a placebo. 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 17 Dec 2019). 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?
PCO2 Level Outside of Desired Range (40-60 mmHg) (time frame: Admission to NICU, approximately 1 hour of life). 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 17 Dec 2019; AzTrials last refreshed its copy on 7 Nov 2026.