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NCT06258187: CO2-Vent

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

Active, enrolled NA Last updated 2 March 2026
What this trial tests

NA trial testing Pedi-Cap in Neonatal Resuscitation in 632 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 March 2024
Primary endpoint
1 March 2026
30 March 2026

Quick facts

Lead sponsorUniversity of Texas Southwestern Medical Center
PhaseNA
StatusActive, enrolled
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposediagnostic
Enrollment632
Start date1 March 2024
Primary completion1 March 2026
Estimated completion30 March 2026
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Texas Southwestern Medical Center

Who can join

30 Weeks and older, any sex, with Neonatal Resuscitation or Neonatal Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Neonatal Resuscitation

Currently open trials in the same condition.

Other University of Texas Southwestern Medical Center trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06258187.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing