Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants

Last updated: January 28, 2025
Sponsor: Milton S. Hershey Medical Center
Overall Status: Completed

Phase

N/A

Condition

Lung Disease

Treatment

Body positioning

Clinical Study ID

NCT05968586
22600
  • Ages 1-3
  • All Genders

Study Summary

This research study is being done to investigate the effect of changing an infant's body position on how hard the baby works to breathe, the baby's oxygen level, the baby's carbon dioxide level, the baby's lung volume, the baby's lung compliance (ability of the lung to expand and fill with air), and how frequently the baby develops clinically significant events such as apnea (baby stops breathing on his own), bradycardia (low heart rate), and desaturation (low oxygen) events.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Viable infants born at ≤32 weeks of gestation on non-invasive NAVA.

  • Infant must be stable on NAVA for at least 24 hours prior to the study

Exclusion

Exclusion Criteria:

  • Infants with congenital heart disease (CHD)

  • Infants with persistent pulmonary hypertension (PPHN)

  • Infants with contraindications to using NAVA (e.g. neuromuscular blockage orparalysis, absent electrical signal from the diaphragm, esophageal tears orbleeding, cardiac pacemakers) or infants in whom an NG/OG catheter cannot be placed.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Body positioning
Phase:
Study Start date:
September 11, 2023
Estimated Completion Date:
December 31, 2024

Connect with a study center

  • Penn State Health Milton S Hershey Medical Center

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.