Clinical trial NCT06258187: Pedi-Cap CO2 Detector for Face-mask Ventilation in the Delivery Room
Official title: Randomized Control Trial of Colorimetric CO2 Detectors for Ventilation Assessment in the Delivery Room
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Resuscitation
Neonatal Disease
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 632
Sex: ALL
Minimum age (years): 30
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: DIAGNOSTIC

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of positive pressure ventilation (PPV)
timeFrame: From birth to end of delivery room resuscitation or admission to the Neonatal Intensive Care Unit (NICU) (approximately 1 hour of life)
Secondary outcomes:
measure: Duration of bradycardia
timeFrame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
measure: Time to heart rate great than 100 beats per minute
timeFrame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
measure: time to start of ventilatory corrective maneuvers
timeFrame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
measure: Maximum peak inspiratory pressure used
timeFrame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
measure: Time to gold color change on Pedi-Cap
timeFrame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
measure: Need for intubation in the delivery room
timeFrame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
measure: need for delayed positive pressure ventilation
timeFrame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
measure: Need for chest compressions or epinephrine
timeFrame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
measure: Need for neonatal intensive care unit admission if infant ≥35 gestational age
timeFrame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
measure: Occurrence of pneumothorax
timeFrame: From birth to 3 days of life
measure: Duration of mechanical ventilation
timeFrame: From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks
measure: Need for surfactant
timeFrame: From birth to date of discharge or death, whichever comes first, assessed up to 50 weeks
measure: Maximum positive end expiratory pressure used
timeFrame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
measure: Maximum fractionated inspired oxygen used
timeFrame: From birth to end of delivery room resuscitation or admission to the NICU (approximately 1 hour of life)
measure: Survival to discharge
timeFrame: birth to discharge from NICU (up to 12 months of age)
Other outcomes:
measure: Initial heart rate at birth
timeFrame: From birth to initial assessment by resuscitation team members (approximately by 2 minutes of life)
Locations:
city: Dallas
country: United States
facility: Parkland Health
state: Texas
Study officials:
affiliation: University of Texas
name: Riti Chokshi
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Weiner MDFGM. NRP Textbook of Neonatal Resuscitation. 8th. ed. Itasca: American Academy of Pediatrics; 2021.
citation: 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