Non-invasive Ventilation With Neurally Adjusted Ventilatory Assist Versus Nasal Continuous Airway Pressure in Premature Infants

NCT ID: NCT01624012

Last Updated: 2016-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2016-05-31

Brief Summary

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The purpose of this study is to compare if a new noninvasive ventilation mode (NIV NAVA) is better in noninvasive ventilation of premature infants than currently used Nasal Continuous Airway Pressure (ncpap), and if NIV NAVA gives real benefits for patients or not.

The investigators study hypothesis is that with NIV NAVA the invasive ventilation is more synchronous with patient, which will lead to a decrease in need of inspired oxygen.

Detailed Description

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Conditions

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Respiratory Distress Syndrome (RDS) of Neonate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NIV NAVA

Noninvasive ventilation in this group is practiced with NIV NAVA

Group Type ACTIVE_COMPARATOR

NIV NAVA

Intervention Type DEVICE

Non invasive ventilation with neurally adjusted ventilatory assist

ncpap

Patients randomized to this arm will receive noninvasive ventilation with continuous nasal CPAP as routinely in neonatal intensive care unit.

Group Type ACTIVE_COMPARATOR

Nasal continuous positive airway pressure

Intervention Type DEVICE

Noninvasive respiratory support with continuous positive airway pressure

Interventions

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NIV NAVA

Non invasive ventilation with neurally adjusted ventilatory assist

Intervention Type DEVICE

Nasal continuous positive airway pressure

Noninvasive respiratory support with continuous positive airway pressure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* postconceptional age 28+0 - 36+6
* need of ncpap treatment and inspired oxygen for at least 60 minutes

Exclusion Criteria

* severe birth asphyxia, malformation or chromosomal abnormality, or other condition, which will decrease life expectancy
* any condition which prevents insertion of naso/orogastric tube
Minimum Eligible Age

1 Hour

Maximum Eligible Age

48 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Merja Ålander

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oulu University hospital

Oulu, , Finland

Site Status

Countries

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Finland

Other Identifiers

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EETTMK:23/2011

Identifier Type: -

Identifier Source: org_study_id

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