Neonatal ResuscitationCO2-VentNCT06258187
Pedi-Cap CO2 Detector for Face-mask Ventilation in the Delivery Room
A study testing Pedi-Cap in people with Neonatal Resuscitation and Neonatal Disease, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The goal of this study is to determine if using a Pedi-Cap (a type of colorimetric carbon dioxide detector) during face mask ventilation (PPV) for newborn infants in the delivery room will lower the time of PPV needed. Read more about this study
- Who is it for?
- Ages 30 weeks and older
- Conditions the study is for
- Neonatal Resuscitation, Neonatal Disease
- What is being tested?
- Pedi-Cap
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 632 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 30 Mar 2026
- Phase
- Interventional
- 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 30 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Infants born at ≥30 weeks' gestation
- Presence of the resuscitation team prior to delivery
- Need for non-invasive positive pressure ventilation (PPV).
Who cannot join
- Infants born at <30 weeks' gestation
- No non-invasive PPV needed in the delivery room
- Infants with conditions requiring immediate intubation such as congenital diaphragmatic hernia
- Resuscitation team not present prior to delivery/need for PPV
- Infants who have a prenatal plan of comfort care only
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Control Trial of Colorimetric CO2 Detectors for Ventilation Assessment in the Delivery Room
The goal of this study is to determine if using a Pedi-Cap (a type of colorimetric carbon dioxide detector) during face mask ventilation (PPV) for newborn infants in the delivery room will lower the time of PPV needed. A group of nurses, doctors, and respiratory therapists, called the neonatal resuscitation team, will either use or not use the Pedi-Cap during face mask PPV for infants born at ≥30 weeks' gestation.
A randomization generator will assign each month to either use the Pedi-Cap or not use the Pedi-Cap. The researchers will collect information from the medical chart to find the infant and mother's information, medical interventions done in the delivery room, and lab values. In addition, resuscitation team members will fill out a survey of their experiences of using or not using the Pedi-Cap during delivery room facemask PPV.
Read the detailed description
This is an open, prospective, quasi-randomized, single center trial that will address the primary research question: Does use of a colorimetric carbon dioxide (CO2) detector (Pedi-Cap) decrease the duration of non-invasive positive pressure ventilation (PPV) in the delivery room? The neonatal resuscitation team, comprised of nurses, doctors, and respiratory therapists will include or omit the Pedi-Cap during noninvasive PPV for infants born at ≥30 weeks' gestation in the delivery room. The quasi-randomization scheme will be determined by a opening an opaque envelope each month. This will be revealed at the beginning of each month on whether to use the Pedi-Cap or not. Other outcomes variables that will be assessed include initial heart rate (HR), time to HR > 100 bpm, duration of bradycardia, time to start of ventilation corrective maneuvers (if needed), maximum peak inspiratory pressure used, maximum peek inspiratory pressure used, maximum fractionated inspired oxygen, time to gold color change on Pedi-Cap, need for intubation, need for delayed PPV, need for chest compressions/epinephrine, need for neonatal intensive care unit admission if infant ≥35 gestational age, occurrence of pneumothorax, length of mechanical ventilation in days, doses of surfactant given, and survival to discharge. Infant and maternal characteristics will be obtained from the electronic medical record. Association of outcomes with each study arm will be stratified by infant and maternal characteristics.
In addition, a survey will be administered to the resuscitation team members at the completion of the study to assess their experience with each study arm.
- Conditions
- Neonatal Resuscitation, Neonatal Disease
- Being tested
- Pedi-Cap
- Medical subject headings
- Infant, Newborn, Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pedi-CapDevice
Also called Colorimetric carbon dioxide (CO2) detector
The neonatal resuscitation team will include or omit the use of Pedi-Cap during non-invasive positive pressure ventilation (PPV) for infants ≥30 weeks in the delivery room based on the randomized study arm each month.
| Study group | Role | What they receive |
|---|---|---|
| Pedi-Cap | Experimental | A Pedi-Cap will be connected to the T-piece resuscitator in between the T-piece and face mask. With effective gas exchange, carbon dioxide (CO2) is detected by the Pedi-cap and will demonstrate gold color change with each exhalation. If there is no CO2 gas exchanged, the Pedi-Cap color will remain purple. The color change will be used as one of the tools for the resuscitation team to determine if the infant has effective non-invasive positive pressure ventilation (PPV) during delivery room resuscitation. Other ways, in addition to the Pedi-Cap, to determine effective PPV include a rise in heart rate, improved infant color, chest rise, and improvement in oxygen saturation. Receives: Device: Pedi-Cap |
| No Pedi-Cap | No intervention | There will be no Pedi-Cap attached to the t-piece resuscitator. Effective non-invasive positive pressure ventilation (PPV) during delivery room resuscitation will be assessed by a rise in heart rate, improved infant color, chest rise, and improvement in oxygen saturation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of positive pressure ventilation (PPV)
The time that an infant needs non-invasive PPV during delivery room resuscitation.
Measured: From birth to end of delivery room resuscitation or admission to the Neonatal Intensive Care Unit (NICU) (approximately 1 hour of life)
Secondary outcomes (15)
Duration of bradycardia
The time that an infant has a heart rate of less than 100 beat per minute during delivery room resuscitation.
Measured: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Time to heart rate great than 100 beats per minute
The ultimate goal of a successful delivery room resuscitation is to sustain the infant's heart rate above 100 beats per minute.
Measured: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
time to start of ventilatory corrective maneuvers
As per the neonatal resuscitation program algorithm 8th edition, if the infant's heart rate does not improve with non-invasive ventilation, corrective steps must be taken to optimize non-invasive ventilation such as suctioning, repositioning, adjusting the mask, opening the mouth/nose, and increasing the peak inspiratory pressure.
Measured: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Maximum peak inspiratory pressure used
As per the neonatal resuscitation program algorithm 8th edition, if the infant's heart rate does not improve with non-invasive ventilation, corrective steps must be taken to optimize non-invasive ventilation such as increasing peak inspiratory pressure.
Measured: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Time to gold color change on Pedi-Cap
Gold color change on the Pedi-Cap indicates carbon dioxide (CO2) exchange occurring and correlates with increased tidal volumes and increased heart rate.
Measured: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Need for intubation in the delivery room
Need for intubation as per the neonatal resuscitation program algorithm 8th edition if the infant's heart rate does not improve with non-invasive ventilation.
Measured: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
need for delayed positive pressure ventilation
Need for a subsequent positive pressure ventilation after an initial cessation
Measured: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Need for chest compressions or epinephrine
Need for chest compression and epinephrine as per the neonatal resuscitation program algorithm 8th edition if the infant's heart rate does not improve with invasive ventilation.
Measured: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Need for neonatal intensive care unit admission if infant ≥35 gestational age
Generally, infants born ≥35 gestational age are not admitted to the neonatal intensive care unit unless there are delivery room complications or neonatal disease.
Measured: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Occurrence of pneumothorax
The risk of positive pressure ventilation can be a pneumothorax.
Measured: From birth to 3 days of life
Duration of mechanical ventilation
The number of days and infant requires mechanical ventilation
Measured: From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks
Need for surfactant
The need for surfactant administration
Measured: From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks
Maximum positive end expiratory pressure used
As per the neonatal resuscitation program algorithm 8th edition, if the infant does not have good oxygen saturation, interventions must be done to meet goal saturations for each minute of life.
Measured: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Maximum fractionated inspired oxygen used
As per the neonatal resuscitation program algorithm 8th edition, if the infant does not have good oxygen saturation, interventions must be done to meet goal saturations for each minute of life.
Measured: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Survival to discharge
Determination if the infant is discharged home
Measured: birth to discharge from NICU (up to 12 months of age)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study start1 Mar 2024
- Primary completion1 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neonatal 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The quasi-randomization scheme will be determined by a non-investigator for each month. This will be revealed at the beginning of each month on whether to use Pedi-Cap or not during delivery room resuscitation using sealed, opaque envelopes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 632 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riti Chokshi, MD, University of Texas Southwestern Medical Center
- Investigators
- Riti Chokshi, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06258187
- Sponsor's protocol ID
- STU-2023-0969
- Acronym
- CO2-Vent
- Status last verified
- Feb 2026
- First submitted
- 15 Jan 2024
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres J, Fawke J, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kim HS, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Rabi Y, Roehr CC, Schmolzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM; Neonatal Life Support Collaborators. Neonatal Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2020 Oct 20;142(16_suppl_1):S185-S221. doi: 10.1161/CIR.0000000000000895. Epub 2020 Oct 21.
PubMed 33084392Perlman JM, Wyllie J, Kattwinkel J, Atkins DL, Chameides L, Goldsmith JP, Guinsburg R, Hazinski MF, Morley C, Richmond S, Simon WM, Singhal N, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Neonatal resuscitation: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Pediatrics. 2010 Nov;126(5):e1319-44. doi: 10.1542/peds.2010-2972B. Epub 2010 Oct 18. No abstract available.
PubMed 20956431Weiner MDFGM. NRP Textbook of Neonatal Resuscitation. 8th. ed. Itasca: American Academy of Pediatrics; 2021.
ILCOR Summary Statement: 2023 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendation 2023 [Available from: https://ilcor.org/publications/preprint
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Control Trial of Colorimetric CO2 Detectors for Ventilation Assessment in the Delivery Room
- ClinicalTrials.gov ID
- NCT06258187
- Acronym / sponsor ID
- CO2-Vent / STU-2023-0969
- Conditions
- Neonatal Resuscitation, Neonatal Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 632 participants (estimated)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 14 Feb 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.
The goal of this study is to determine if using a Pedi-Cap (a type of colorimetric carbon dioxide detector) during face mask ventilation (PPV) for newborn infants in the delivery room will lower the time of PPV needed. A group of nurses, doctors, and respiratory therapists, called the neonatal resuscitation team, will either use or not use the Pedi-Cap during face mask PPV for infants born at ≥30 weeks' gestation.
A randomization generator will assign each month to either use the Pedi-Cap or not use the Pedi-Cap. The researchers will collect information from the medical chart to find the infant and mother's information, medical interventions done in the delivery room, and lab values. In addition, resuscitation team members will fill out a survey of their experiences of using or not using the Pedi-Cap during delivery room facemask PPV.
Detailed description
This is an open, prospective, quasi-randomized, single center trial that will address the primary research question: Does use of a colorimetric carbon dioxide (CO2) detector (Pedi-Cap) decrease the duration of non-invasive positive pressure ventilation (PPV) in the delivery room? The neonatal resuscitation team, comprised of nurses, doctors, and respiratory therapists will include or omit the Pedi-Cap during noninvasive PPV for infants born at ≥30 weeks' gestation in the delivery room. The quasi-randomization scheme will be determined by a opening an opaque envelope each month. This will be revealed at the beginning of each month on whether to use the Pedi-Cap or not. Other outcomes variables that will be assessed include initial heart rate (HR), time to HR > 100 bpm, duration of bradycardia, time to start of ventilation corrective maneuvers (if needed), maximum peak inspiratory pressure used, maximum peek inspiratory pressure used, maximum fractionated inspired oxygen, time to gold color change on Pedi-Cap, need for intubation, need for delayed PPV, need for chest compressions/epinephrine, need for neonatal intensive care unit admission if infant ≥35 gestational age, occurrence of pneumothorax, length of mechanical ventilation in days, doses of surfactant given, and survival to discharge. Infant and maternal characteristics will be obtained from the electronic medical record. Association of outcomes with each study arm will be stratified by infant and maternal characteristics.
In addition, a survey will be administered to the resuscitation team members at the completion of the study to assess their experience with each study arm.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The quasi-randomization scheme will be determined by a non-investigator for each month. This will be revealed at the beginning of each month on whether to use Pedi-Cap or not during delivery room resuscitation using sealed, opaque envelopes.
| Arm | Type | Receives |
|---|---|---|
| Pedi-Cap | Experimental | Device: Pedi-CapA Pedi-Cap will be connected to the T-piece resuscitator in between the T-piece and face mask. With effective gas exchange, carbon dioxide (CO2) is detected by the Pedi-cap and will demonstrate gold color change with each exhalation. If there is no CO2 gas exchanged, the Pedi-Cap color will remain purple. The color change will be used as one of the tools for the resuscitation team to determine if the infant has effective non-invasive positive pressure ventilation (PPV) during delivery room resuscitation. Other ways, in addition to the Pedi-Cap, to determine effective PPV include a rise in heart rate, improved infant color, chest rise, and improvement in oxygen saturation. |
| No Pedi-Cap | No intervention | –There will be no Pedi-Cap attached to the t-piece resuscitator. Effective non-invasive positive pressure ventilation (PPV) during delivery room resuscitation will be assessed by a rise in heart rate, improved infant color, chest rise, and improvement in oxygen saturation. |
Who may qualify
- Ages
- 30 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Infants born at ≥30 weeks' gestation
- Presence of the resuscitation team prior to delivery
- Need for non-invasive positive pressure ventilation (PPV).
Key exclusion criteria (5 listed)
- Infants born at <30 weeks' gestation
- No non-invasive PPV needed in the delivery room
- Infants with conditions requiring immediate intubation such as congenital diaphragmatic hernia
- Resuscitation team not present prior to delivery/need for PPV
- Infants who have a prenatal plan of comfort care only
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 |
|---|---|---|
| Pedi-CapAlso: Colorimetric carbon dioxide (CO2) detectorThe neonatal resuscitation team will include or omit the use of Pedi-Cap during non-invasive positive pressure ventilation (PPV) for infants ≥30 weeks in the delivery room based on the randomized study arm each month. | Device | Pedi-Cap |
Primary outcome
Duration of positive pressure ventilation (PPV)
Time frame: From birth to end of delivery room resuscitation or admission to the Neonatal Intensive Care Unit (NICU) (approximately 1 hour of life)
The time that an infant needs non-invasive PPV during delivery room resuscitation.
15 secondary outcomes
Duration of bradycardia
Time frame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Time to heart rate great than 100 beats per minute
Time frame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
time to start of ventilatory corrective maneuvers
Time frame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Maximum peak inspiratory pressure used
Time frame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Time to gold color change on Pedi-Cap
Time frame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Need for intubation in the delivery room
Time frame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
need for delayed positive pressure ventilation
Time frame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Need for chest compressions or epinephrine
Time frame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Need for neonatal intensive care unit admission if infant ≥35 gestational age
Time frame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Occurrence of pneumothorax
Time frame: From birth to 3 days of life
Duration of mechanical ventilation
Time frame: From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks
Need for surfactant
Time frame: From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks
Maximum positive end expiratory pressure used
Time frame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Maximum fractionated inspired oxygen used
Time frame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
Survival to discharge
Time frame: birth to discharge from NICU (up to 12 months of age)
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 2 Mar 2026.
- Background: PubMed 33084392Wyckoff MH, Wyllie J, Aziz K, de Almeida MF, Fabres J, Fawke J, Guinsburg R, Hosono S, Isayama T, Kapadia VS, Kim HS, Liley HG, McKinlay CJD, Mildenhall L, Perlman JM, Rabi Y, Roehr CC, Schmolzer GM, Szyld E, Trevisanuto D, Velaphi S, Weiner GM; Neonatal Life Support Collaborators. Neonatal Life Support: 2020 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science With Treatment Recommendations. Circulation. 2020 Oct 20;142(16_suppl_1):S185-S221. doi: 10.1161/CIR.0000000000000895. Epub 2020 Oct 21.
- Background: PubMed 20956431Perlman JM, Wyllie J, Kattwinkel J, Atkins DL, Chameides L, Goldsmith JP, Guinsburg R, Hazinski MF, Morley C, Richmond S, Simon WM, Singhal N, Szyld E, Tamura M, Velaphi S; Neonatal Resuscitation Chapter Collaborators. Neonatal resuscitation: 2010 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendations. Pediatrics. 2010 Nov;126(5):e1319-44. doi: 10.1542/peds.2010-2972B. Epub 2010 Oct 18. No abstract available.
- BackgroundWeiner MDFGM. NRP Textbook of Neonatal Resuscitation. 8th. ed. Itasca: American Academy of Pediatrics; 2021.
- BackgroundILCOR Summary Statement: 2023 International Consensus on Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Science with Treatment Recommendation 2023 [Available from: https://ilcor.org/publications/preprint
- 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.
Riti Chokshi principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pedi-Cap in people with Neonatal Resuscitation and Neonatal Disease, 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 3 inclusion and 5 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 2 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?
Duration of positive pressure ventilation (PPV) (time frame: From birth to end of delivery room resuscitation or admission to the Neonatal Intensive Care Unit (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?
On the ClinicalTrials.gov record for NCT06258187, 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 2 Mar 2026.