GentleFit Non-Invasive Ventilation (NIV) Interface Trial

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

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.
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