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NCT02518230 · ClinicalTrials.gov registry record · NA

Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants

A NA study, sponsored by Children's Mercy Hospital Kansas City.

Completed
Registry status
NA
Development phase
22
Enrollment target

NCT02518230: Completed NA study, sponsored by Children's Mercy Hospital Kansas City.

NCT02518230 is a NA study that has completed, run by Children's Mercy Hospital Kansas City. The registered enrollment target is 22 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02518230, a NA study, has completed, sponsored by Children's Mercy Hospital Kansas City.

COMPLETED
Registry status
NA
Development phase
22 participants
Enrollment target

Study Summary

This study is a single center, prospective cohort crossover study comparing mechanically ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and synchronized intermittent mandatory ventilation with pressure control plus pressure support (SIMV(PC) + PS) modes. This design will allow for direct comparison of two commonly used ventilator modalities in the neonatal intensive care unit (NICU) to determine if one mode is superior to the other with regards to respiratory mechanics and estimated energy expenditure. It is hypothesized that neonates and infants will have improved respiratory severity score (MAP X FiO2) utilizing NAVA compared to the SIMV (PC) + PS mode but will have increased estimated energy expenditure.

Primary Outcome

The respiratory severity score will be calculated throughout 24 hour time frame prior to and after study initiation to determine the subject's respiratory severity prior to the randomization, after randomization and after crossover. The respiratory severity score (RSS) is a simplified severity score consisting of the mean airway pressure (MAP) multiplied by the fraction of inspired oxygen (FiO2). This score ranges from 0 to 12, with a higher score indicating more severe disease.

Interventions

  • DEVICE Neurally Adjusted Ventilatory Assist
  • DEVICE Synchronized Interm. Mandatory Assist

Trial Details

FieldValue
Enrollment Target 22 participants
Start Date 2014-01
Est. Completion 2015-06
Phase NA

What the finished NCT02518230 record still lists

NCT02518230 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).

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

NCT02518230 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02518230 about?

NCT02518230 is a clinical study titled "Randomized Crossover of NAVA and Synchronized Intermittent Pressure Ventilation in Neonates and Infants". This study is a single center, prospective cohort crossover study comparing mechanically ventilated neonates and infants on Neurally Adjusted Ventilatory Assist (NAVA) and synchronized intermittent mandatory ventilation with pressure control plus pressure support (SIMV(PC) + PS) modes. This design ...

What is the current status of trial NCT02518230?

This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2014-01. Estimated completion is 2015-06.

What interventions are being tested in trial NCT02518230?

The interventions under investigation include: Neurally Adjusted Ventilatory Assist (DEVICE), Synchronized Interm. Mandatory Assist (DEVICE).

Who is sponsoring clinical trial NCT02518230?

This trial is sponsored by Children's Mercy Hospital Kansas City, which has 184 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02518230's enrollment target sits among peer trials

22 1756th of 2000 higher than 239 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 NCT02518230, the US trial registry maintained by the National Library of Medicine. NCT02518230 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.