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

Neonatal Disease Clinical Trial

— CO2-Vent  

Official title:

Randomized Control Trial of Colorimetric CO2 Detectors for Ventilation Assessment in the Delivery Room

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06258187
• Other study ID #: STU-2023-0969
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: July 2025

Study information

• Verified date: March 2024
• Source: University of Texas Southwestern Medical Center
• Contact: Riti Chokshi, MD
• Phone: 214-456-5802
• Email: riti.chokshi[@]utsouthwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 either using the Pedi-Cap or not using the Pedi-Cap. The researchers will collect information from the chart to find the infant and mother's information, vital signs, 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 PPV.

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 use of 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 randomizer for each month. This will be revealed at the beginning of each month on whether to use 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, 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, and need for surfactant. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 632
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Weeks and older

Eligibility

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

Related Conditions & MeSH terms

• Infant, Newborn, Diseases
• Neonatal Disease
• Neonatal Resuscitation

Intervention

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.

Locations

Country	Name	City	State
United States	Parkland Health	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (4)

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

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. — View Citation

Weiner MDFGM. NRP Textbook of Neonatal Resuscitation. 8th. ed. Itasca: American Academy of Pediatrics; 2021.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Occurrence of pneumothorax	The risk of positive pressure ventilation can be a pneumothorax.	From birth to 3 days of life
Secondary	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
Secondary	Need for surfactant	The need for surfactant administration	From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks