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NCT06258187 · ClinicalTrials.gov registry record · NA
Pedi-Cap CO2 Detector for Face-mask Ventilation in the Delivery Room
A NA study of Neonatal Resuscitation and Neonatal Disease, sponsored by University of Texas Southwestern Medical Center.
- Active
- Registry status
- NA
- Development phase
- 632
- Enrollment target
- 1
- Study location
NCT06258187: Active NA study of Neonatal Resuscitation and Neonatal Disease, sponsored by University of Texas Southwestern Medical Center.
NCT06258187 is a NA study of Neonatal Resuscitation and Neonatal Disease that is active but no longer recruiting, run by University of Texas Southwestern Medical Center. The registered enrollment target is 632 participants, below the 12,434-participant average among 3 other Neonatal Resuscitation trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06258187, a NA study of Neonatal Resuscitation and Neonatal Disease, is active but no longer recruiting, sponsored by University of Texas Southwestern Medical Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 632 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
The time that an infant needs non-invasive PPV during delivery room resuscitation.
Conditions Studied
Interventions
- DEVICE Pedi-Cap
Study Locations (1)
Texas
- Parkland Health - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 632 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2026-03-30 |
| Phase | NA |
What the registry record for NCT06258187 still lists
NCT06258187 is an interventional study that assigns participants to a tested intervention. The registered 632 participants enrollment target is mid-sized for trials with a published cap, below the 12,434-participant average among 3 other Neonatal Resuscitation trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Neonatal Resuscitation appearing as the primary indexed condition, and to 1 intervention - of which Pedi-Cap is the first listed.
NCT06258187 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT06258187 about?
NCT06258187 is a clinical study titled "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 resus...
What is the current status of trial NCT06258187?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 632 participants. The study started on 2024-03-01. Estimated completion is 2026-03-30.
What conditions does trial NCT06258187 study?
This clinical trial studies the following conditions: Neonatal Resuscitation, Neonatal Disease.
What interventions are being tested in trial NCT06258187?
The interventions under investigation include: Pedi-Cap (DEVICE).
Who is sponsoring clinical trial NCT06258187?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06258187 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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