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

Premature Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05968586
• Other study ID #: 22600
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: March 2024
• Source: Milton S. Hershey Medical Center
• Contact: Nada Darwish, MD
• Phone: 717-531-8941
• Email: ndarwish[@]pennstatehealth.psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Minute to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Apnea of Prematurity
• Bronchopulmonary Dysplasia
• Premature
• Premature Birth
• Ventilator Lung; Newborn

Intervention

Other:
• Body positioning
Body positioning of infants prone vs supine.

Locations

Country	Name	City	State
United States	Penn State Health Milton S Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak electrical activity of the diaphragm (Edi peaks)	Height of Edi signal in uV	From enrollment in study to end of study (a total of twelve hours)
Primary	Minimum electrical activity of the diaphragm (Edi mins)	Lowest of Edi signal in uV	From enrollment in study to end of study (a total of twelve hours)
Primary	Number of apenic events	Number of times where infant ceases to breath for >5 seconds	From enrollment in study to end of study (a total of twelve hours)
Primary	Number of bradycardia events	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)
Primary	Number of desaturation events	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)