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NCT03180385 · ClinicalTrials.gov registry record · NA

NAVA Versus BiPAP Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery

A NA study, sponsored by Children's Hospitals and Clinics of Minnesota.

Terminated
Registry status
NA
Development phase
15
Enrollment target

NCT03180385: Clinical Trial NA study, sponsored by Children's Hospitals and Clinics of Minnesota.

NCT03180385 is a NA study that was terminated before completion, run by Children's Hospitals and Clinics of Minnesota. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03180385, a NA study, was terminated before completion, sponsored by Children's Hospitals and Clinics of Minnesota.

TERMINATED
Registry status
NA
Development phase
15 participants
Enrollment target

Study Summary

Pediatric patients often require prolonged mechanical ventilation after cardiac surgery which comes with many undesirable effects. As a result, neurally-adjusted ventilatory assist (NAVA) and biphasic positive airway pressure support (BiPAP) have been developed as non-invasive alternatives to providing respiratory support post-operatively. The investigators hypothesize that providing synchronized biphasic support with NAVA will be associated with shorter duration of non-invasive respiratory support, less sedation requirements, and reduced length of hospital stay. This is a prospective, randomized study. Subjects are randomized to receive either NAVA or BiPAP following their cardiothoracic surgery.

Interventions

  • DEVICE Neurally-Adusted Ventilatory Assist (NAVA)
  • DEVICE Biphasic Positive Airway Pressure Support (BiPAP)

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 2017-03-01
Est. Completion 2018-04-10
Phase NA

Why NCT03180385 stopped before completion

NCT03180385 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).

The record links to 0 conditions, and to 2 interventions - of which Neurally-Adusted Ventilatory Assist (NAVA) is the first listed.

NCT03180385 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03180385 about?

NCT03180385 is a clinical study titled "NAVA Versus BiPAP Non-Invasive Respiratory Support in Infants Following Congenital Heart Surgery". Pediatric patients often require prolonged mechanical ventilation after cardiac surgery which comes with many undesirable effects. As a result, neurally-adjusted ventilatory assist (NAVA) and biphasic positive airway pressure support (BiPAP) have been developed as non-invasive alternatives to provid...

What is the current status of trial NCT03180385?

This trial is currently terminated. It is a NA study. The enrollment target is 15 participants. The study started on 2017-03-01. Estimated completion is 2018-04-10.

What interventions are being tested in trial NCT03180385?

The interventions under investigation include: Neurally-Adusted Ventilatory Assist (NAVA) (DEVICE), Biphasic Positive Airway Pressure Support (BiPAP) (DEVICE).

Who is sponsoring clinical trial NCT03180385?

This trial is sponsored by Children's Hospitals and Clinics of Minnesota, which has 31 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03180385's enrollment target sits among peer trials

15 1881st of 2000 higher than 92 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03180385, the US trial registry maintained by the National Library of Medicine. NCT03180385 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.