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

January 28, 2025 updated by: Nada Darwish, Milton S. Hershey Medical Center

Effect of Body Position on Oxygenation, Ventilation, and Diaphragmatic Workload in Premature Infants on Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Penn State Health Milton S Hershey Medical Center

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.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Criteria:

  • Infants with congenital heart disease (CHD)
  • Infants with persistent pulmonary hypertension (PPHN)
  • Infants with contraindications to using NAVA (e.g. neuromuscular blockage or paralysis, absent electrical signal from the diaphragm, esophageal tears or bleeding, cardiac pacemakers) or infants in whom an NG/OG catheter cannot be placed.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Prone positioning
Other: Body positioning
Body positioning of infants prone vs supine.
Active Comparator: Supine positioning
Other: Body positioning
Body positioning of infants prone vs supine.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak electrical activity of the diaphragm (Edi peaks)
Time Frame: From enrollment in study to end of study (a total of twelve hours)
Height of Edi signal in uV
From enrollment in study to end of study (a total of twelve hours)
Minimum electrical activity of the diaphragm (Edi mins)
Time Frame: From enrollment in study to end of study (a total of twelve hours)
Lowest of Edi signal in uV
From enrollment in study to end of study (a total of twelve hours)
Number of apenic events
Time Frame: From enrollment in study to end of study (a total of twelve hours)
Number of times where infant ceases to breath for >5 seconds
From enrollment in study to end of study (a total of twelve hours)
Number of bradycardia events
Time Frame: From enrollment in study to end of study (a total of twelve hours)
Number of times where infant's heart rate drops <100bpm sustained for >5s
From enrollment in study to end of study (a total of twelve hours)
Number of desaturation events
Time Frame: From enrollment in study to end of study (a total of twelve hours)
Number of times where infant's oxygen saturation drops <85% sustained for >5s
From enrollment in study to end of study (a total of twelve hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milton S. Hershey Medical Center

Investigators

  • Study Director: Kristin Glass, MD, Penn State College of Medicine

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 Major Dates

Study Start (Actual)

September 11, 2023

Primary Completion (Actual)

December 28, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

July 21, 2023

First Submitted That Met QC Criteria

July 21, 2023

First Posted (Actual)

August 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 28, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22600

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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