ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-03-01
Study Completion:2026-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06258187

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:30 Weeks
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Infants born at ≥30 weeks' gestation
  2. * Presence of the resuscitation team prior to delivery
  3. * Need for non-invasive positive pressure ventilation (PPV).
  1. * Infants born at \<30 weeks' gestation
  2. * No non-invasive PPV needed in the delivery room
  3. * Infants with conditions requiring immediate intubation such as congenital diaphragmatic hernia
  4. * Resuscitation team not present prior to delivery/need for PPV
  5. * Infants who have a prenatal plan of comfort care only

Contacts and Locations

Principal Investigator

Riti Chokshi
PRINCIPAL_INVESTIGATOR
University of Texas

Study Locations (Sites)

Parkland Health
Dallas, Texas, 75235
United States

Collaborators and Investigators

Sponsor: University of Texas Southwestern Medical Center

  • Riti Chokshi, PRINCIPAL_INVESTIGATOR, University of Texas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-01
Study Completion Date2026-03-30

Study Record Updates

Study Start Date2024-03-01
Study Completion Date2026-03-30

Terms related to this study

Additional Relevant MeSH Terms

  • Neonatal Resuscitation
  • Neonatal Disease