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

NCT05968586 — Not applicable, Completed, 30 participants, Milton S. Hershey Medical Center

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

Registry	NCT05968586
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	30 (Actual)
Sponsor	Milton S. Hershey Medical Center (Other)
Conditions	Neonatal Oxygen Desaturation, Premature, Ventilator Lung; Newborn, Apnea of Prematurity
Interventions	Body positioning (Other)
Dates	start 2023-09-11, primary completion 2024-12-28, completion 2024-12-31, first posted 2023-08-01, last updated 2025-01-29
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Prone positioning	Experimental	Other: Body positioning
Supine positioning	Active comparator	Other: Body positioning

Body positioning (Other): Body positioning of infants prone vs supine.

+Outcome measures

Primary outcomes

Peak electrical activity of the diaphragm (Edi peaks) [From enrollment in study to end of study (a total of twelve hours)]: Height of Edi signal in uV
Minimum electrical activity of the diaphragm (Edi mins) [From enrollment in study to end of study (a total of twelve hours)]: Lowest of Edi signal in uV
Number of apenic events [From enrollment in study to end of study (a total of twelve hours)]: Number of times where infant ceases to breath for >5 seconds
Number of bradycardia events [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
Number of desaturation events [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

+Eligibility

Sex: All, ages: 1 Minute to 3 Months

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.

+Locations (1)

Facility	City	Country	Status
Penn State Health Milton S Hershey Medical Center	Hershey, Pennsylvania	United States

+Investigators

Kristin Glass, MD, Study director, Penn State College of Medicine