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Search / Trial NCT06833294

GentleFit Non-Invasive Ventilation (NIV) Interface Trial

Launched by CHILDREN'S HOSPITAL OF PHILADELPHIA · Feb 12, 2025

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

ClinConnect Summary

The GentleFit Non-Invasive Ventilation (NIV) Interface Trial is a study designed to compare a new nasal mask and nasal prong system, called GentleFit, with the standard breathing devices currently used for children who need help breathing. The goal is to see how well the GentleFit devices work in providing air pressure, while also checking for any skin issues, how the children are doing overall, and whether healthcare providers find the devices easy to use.

To participate in this trial, children between the ages of 38 weeks (corrected gestational age) and 3 years old, who weigh more than 3.5 kg and are stable in their current breathing support for at least the last 6-8 hours, may be eligible. Parents or guardians will need to give their permission for their child to join the study. However, children with certain conditions, like facial injuries or other specific health issues, may not be able to take part. If enrolled, families can expect to monitor the child's comfort and any skin reactions while using the new devices, and they will be part of a study that aims to improve breathing support for young children.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Children with corrected gestational age ≥ 38 weeks through 3 years old weighing \> 3.5kg.
  • 2. Children who are on clinically stable Non-Invasive Ventilation (NIV) settings, defined as no escalation in support in the last 6-8 hours.
  • 3. Parental/guardian permission (informed consent).
  • Exclusion Criteria:
  • 1. Children whose nares, face, or head do not fit the manufacturer sizing guide for nasal mask and nasal prongs.
  • 2. Facial anomalies (e.g. cleft lip).
  • 3. Existing skin injury present in an area where GentleFit NIV interfaces or headgear would contact skin.
  • 4. Patient's emergent condition.
  • -

About Children's Hospital Of Philadelphia

The Children's Hospital of Philadelphia (CHOP) is a leading pediatric healthcare institution renowned for its commitment to advancing child health through innovative research and clinical care. As a prominent clinical trial sponsor, CHOP emphasizes a multidisciplinary approach to pediatric research, fostering collaborations across various specialties to develop and evaluate groundbreaking therapies and interventions. With a focus on improving patient outcomes and enhancing the quality of life for children, CHOP is dedicated to conducting rigorous clinical trials that adhere to the highest ethical standards and scientific integrity, ultimately contributing to the global knowledge base in pediatric medicine.

Locations

Philadelphia, Pennsylvania, United States

Philadelphia, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Natalie Napolitano, PhD

Principal Investigator

Children's Hospital of Philadelphia

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported