Pedi-Cap CO2 Detector for Face-mask Ventilation in the Delivery Room (CO2-Vent)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Neonatal Resuscitation; Neonatal Disease
• Intervention / Treatment: Device: Pedi-Cap

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 Type: Interventional
• Enrollment (Estimated): 632
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Parkland Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Infants born at ≥30 weeks' gestation
• Presence of the resuscitation team prior to delivery
• Need for non-invasive positive pressure ventilation (PPV).

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pedi-Cap; 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.	Device: Pedi-Cap; 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.; Other Names: Colorimetric carbon dioxide (CO2) detector
No Intervention: No Pedi-Cap; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of positive pressure ventilation (PPV)	The time that an infant needs non-invasive PPV during delivery room resuscitation.	From birth to end of delivery room resuscitation or admission to the Neonatal Intensive Care Unit (NICU) (approximately 1 hour of life)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of bradycardia	The time that an infant has a heart rate of less than 100 beat per minute during delivery room resuscitation.	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.	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.	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.	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.	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.	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	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.	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.	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.	From birth to 3 days of life
Duration of mechanical ventilation	The number of days and infant requires mechanical ventilation	From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks
Need for surfactant	The need for surfactant administration	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.	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.	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	birth to discharge from NICU (up to 12 months of age)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Initial heart rate at birth	The initial heart rate in beats per minute at the first recording after birth	From birth to initial assessment by resuscitation team members (approximately by 2 minutes of life)

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Riti Chokshi, University of Texas

Publications and helpful links

General 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.
• Perlman 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.
• Weiner 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 record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: January 15, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 14, 2024

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases
• Other Study ID Numbers: STU-2023-0969

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No