Back to resultsNon-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants
Primary Purpose
Neonatal Oxygen Desaturation, Premature, Ventilator Lung; Newborn
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Body positioning
Sponsored by
About this trial
This is an interventional treatment trial for Neonatal Oxygen Desaturation focused on measuring apnea of prematurity, NAVA
Eligibility Criteria
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.
Sites / Locations
- Penn State Health Milton S Hershey Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Prone positioning
Supine positioning
Arm Description
Outcomes
Primary Outcome Measures
Peak electrical activity of the diaphragm (Edi peaks)
Height of Edi signal in uV
Minimum electrical activity of the diaphragm (Edi mins)
Lowest of Edi signal in uV
Number of apenic events
Number of times where infant ceases to breath for >5 seconds
Number of bradycardia events
Number of times where infant's heart rate drops <100bpm sustained for >5s
Number of desaturation events
Number of times where infant's oxygen saturation drops <85% sustained for >5s
Secondary Outcome Measures
Full Information
NCT ID
NCT05968586
First Posted
July 21, 2023
Last Updated
October 3, 2023
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05968586
Brief Title
Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants
Official Title
Effect of Body Position on Oxygenation, Ventilation, and Diaphragmatic Workload in Premature Infants on Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 11, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neonatal Oxygen Desaturation, Premature, Ventilator Lung; Newborn, Apnea of Prematurity
Keywords
apnea of prematurity, NAVA
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prone positioning
Arm Type
Experimental
Arm Title
Supine positioning
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Body positioning
Intervention Description
Body positioning of infants prone vs supine.
Primary Outcome Measure Information:
Title
Peak electrical activity of the diaphragm (Edi peaks)
Description
Height of Edi signal in uV
Time Frame
From enrollment in study to end of study (a total of twelve hours)
Title
Minimum electrical activity of the diaphragm (Edi mins)
Description
Lowest of Edi signal in uV
Time Frame
From enrollment in study to end of study (a total of twelve hours)
Title
Number of apenic events
Description
Number of times where infant ceases to breath for >5 seconds
Time Frame
From enrollment in study to end of study (a total of twelve hours)
Title
Number of bradycardia events
Description
Number of times where infant's heart rate drops <100bpm sustained for >5s
Time Frame
From enrollment in study to end of study (a total of twelve hours)
Title
Number of desaturation events
Description
Number of times where infant's oxygen saturation drops <85% sustained for >5s
Time Frame
From enrollment in study to end of study (a total of twelve hours)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Minute
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nada Darwish, MD
Phone
717-531-8941
Email
ndarwish@pennstatehealth.psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Mitchell Kresch, MD
Phone
717-531-8413
Email
mkresch@pennstatehealth.psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristin Glass, MD
Organizational Affiliation
Penn State College of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Penn State Health Milton S Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nada Darwish, MD
Phone
717-531-8941
Email
ndarwish@pennstatehealth.psu.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Non-Invasive Neurally Adjusted Ventilatory Assist (NAVA) Prone vs Supine in Premature Infants
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