Lung volume changes with synchronized noninvasive ventilator support in preterm infants

Intrapulmonary Volume Changes During Synchronized Noninvasive Positive Pressure Ventilation In Preterm Infants

This study will use a noninvasive imaging belt to see if synchronized ventilator inflations produce larger lung volumes than unsynchronized or backup inflations in very preterm infants on sNIPPV.

Quick facts

• Study type: Observational
• Enrollment: 27 (estimated)
• Ages: N/A to 4 Weeks
• Sex: All
• Sponsor: University of Zurich (Academic / other)
• Locations: 1 site (Zurich, Canton of Zurich)
• Trial ID: NCT07237139 on ClinicalTrials.gov

What this trial studies

This observational study records lung impedance with Electrical Impedance Tomography (EIT) in preterm infants receiving synchronized noninvasive positive pressure ventilation (sNIPPV). An EIT belt and pulse oximeter are applied and recordings include a 2-minute CPAP baseline followed by return to sNIPPV while the ventilator and abdominal capsule (Graseby) provide synchronization. The primary endpoint is the difference in relative tidal volume (rel. Delta-Z) between spontaneous breaths and synchronized inflations; secondary analyses examine regional aeration and ventilation differences. The ventilator used is the EVEneo and the protocol compares spontaneous, synchronized, non-synchronized, and backup inflations to characterize intrapulmonary mechanisms.

Who should consider this trial

Good fit: Ideal candidates are infants born before 30 0/7 weeks gestation, under 4 weeks old, receiving synchronized NIPPV and whose parents provide written informed consent.

Not a fit: Infants with severe congenital malformations affecting lung aeration or perfusion, those judged too unstable by the treating physician, older than 4 weeks, or not receiving sNIPPV are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could help clinicians fine-tune ventilator timing to improve lung aeration and possibly reduce respiratory failure in very preterm infants.

How similar studies have performed: Clinical trials have shown synchronized NIPPV reduces respiratory failure compared with non‑synchronized modes, but using EIT to detail the intrapulmonary volume changes during different inflation types is a relatively novel, more mechanistic application.

Eligibility criteria

Inclusion Criteria:

* Written informed consent by one or both parents or legal guardians
* Gestational age at birth \< 30 0/7 weeks
* Infants on sNIPPV respiratory support
* Below 4 weeks chronological age

Exclusion Criteria:

* Severe congenital malformation adversely affecting lung aeration or perfusion (e.g., congenital heart defects)
* Too ill/unstable in the opinion of the treating physician.

Where this trial is running

Zurich, Canton of Zurich

• University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)

Study contacts

• Study coordinator: Christoph M Rüegger, MD

Conditions Infant, Preterm; Respiratory Distress Syndrome; Chronic Lung Disease of Newborn; Respiratory Support; Synchronized Noninvasive Positive Pressure Ventilation; Lung Volume; Synchronized noninvasive positive pressure ventilation; Lung volume