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Noninvasive NAVA Versus NIPPV in Low Birthweight Premature Infants

NCT03137225 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2019-11-12

Study results available
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Summary

The investigator hypothesizes that in very low birth weight infants who require respiratory support via noninvasive ventilation, that synchronizing the ventilator breath with the baby's breath using neurally adjusted ventilatory assist (NAVA) will reduce the number and/or severity of apnea/bradycardia/desaturation episodes compared to nasal intermittent positive pressure ventilation (NIPPV).

Conditions

Interventions

DEVICE

Neurally Adjusted Ventilatory Assist

Neurally Adjusted Ventilatory Assist delivered via RAM cannula .

DEVICE

Nasal Intermittent Positive Pressure Ventilation

Nasal Intermittent Positive Pressure Ventilation delivered via RAM cannula

Sponsors & Collaborators

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Henry J Rozycki, MD · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-15
Primary Completion
2017-09-20
Completion
2019-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03137225 on ClinicalTrials.gov