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

Not Applicable

Completed

• Conditions: Apnea of Prematurity; Neonatal Oxygen Desaturation; Premature; Ventilator Lung; Newborn
• Interventions: Other: Body positioning

• Registration Number: NCT05968586
• Lead Sponsor: Milton S. Hershey Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-21
• Study First Submitted QC: 2023-07-21
• Study First Posted: 2023-08-01
• Study Start: 2023-09-11
• Primary Completion: 2024-12-28
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prone positioning	Body positioning	-
Supine positioning	Body positioning	-

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Penn State Health Milton S Hershey Medical Center; 🇺🇸 Hershey, Pennsylvania, United States