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

NCT06258187 | Active Not Recruiting FDA Device

• 1 other identifier: STU-2023-0969
• Study Type: interventional
• Target: 632
• Locations: 1 country
• Sites: 1

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.

Conditions

Neonatal Resuscitation; Neonatal Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Duration of bradycardia

  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

  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

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

• Maximum peak inspiratory pressure used

  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

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

Other Outcomes (1)

• Initial heart rate at birth

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

Study Arms (2)

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.

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.

Interventions

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.

Also known as: Colorimetric carbon dioxide (CO2) detector

Pedi-Cap

Eligibility Criteria

• Age: 30 Weeks+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Health

Dallas, Texas, 75235, United States

Location

Related Publications (4)

• 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.

  PMID: 33084392 BACKGROUND

• 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.

  PMID: 20956431 BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Infant, Newborn, Diseases

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Riti Chokshi

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: February 14, 2024
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 30, 2026
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

US (1)