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NCT Number: NCT06258187

Pedi-Cap CO2 Detector for Face-mask Ventilation 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Neonatal Resuscitation Congenital, Hereditary, and Neonatal Diseases and Abnormalities Infant, Newborn, Diseases Neonatal Disease

Age range

30 week and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Parkland Health

Dallas, Texas, 75235, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pedi-Cap

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Duration of bradycardia

    Time frame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)

    The time that an infant has a heart rate of less than 100 beat per minute during delivery room resuscitation.

  2. 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)

    The ultimate goal of a successful delivery room resuscitation is to sustain the infant's heart rate above 100 beats per minute.

  3. 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)

    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.

  4. 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)

    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.

  5. 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)

    Gold color change on the Pedi-Cap indicates carbon dioxide (CO2) exchange occurring and correlates with increased tidal volumes and increased heart rate.

  6. 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 intubation as per the neonatal resuscitation program algorithm 8th edition if the infant's heart rate does not improve with non-invasive ventilation.

  7. 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 a subsequent positive pressure ventilation after an initial cessation

  8. 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 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.

  9. 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)

    Generally, infants born ≥35 gestational age are not admitted to the neonatal intensive care unit unless there are delivery room complications or neonatal disease.

  10. Occurrence of pneumothorax

    Time frame: From birth to 3 days of life

    The risk of positive pressure ventilation can be a pneumothorax.

  11. Duration of mechanical ventilation

    Time frame: From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks

    The number of days and infant requires mechanical ventilation

  12. Need for surfactant

    Time frame: From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks

    The need for surfactant administration

  13. 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)

    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.

  14. 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)

    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.

  15. Survival to discharge

    Time frame: birth to discharge from NICU (up to 12 months of age)

    Determination if the infant is discharged home

Other outcomes

  1. Initial heart rate at birth

    Time frame: From birth to initial assessment by resuscitation team members (approximately by 2 minutes of life)

    The initial heart rate in beats per minute at the first recording after birth

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Acronym: CO2-Vent

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 14, 2024
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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