Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Brief Summary

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The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants immediately after extubation when recovering from Respiratory distress syndrome (RDS).

Another objective is to examine the effects for synchronized non-invasive mechanical ventilation on gas exchange and cerebral oxygen saturation.

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Detailed Description

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In this study the investigators plan to test the hypothesis that synchronized nasal IMV (S-NIMV) as compared to non-synchronized nasal IMV (NIMV) will decrease breathing effort in preterm infants immediately after extubation when recovery from RDS, as measured by phasic esophageal pressure deflection.

Furthermore, the investigators plan to evaluate the effects of synchronized NIMV on gas exchange and brain oxygenation, and to evaluate the reliability of a newly developed abdominal pressure sensor device for the S-NIMV mode in a newly designed commercially available ventilator device.

Conditions

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Respiratory Distress Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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S-nIMV

nIMV synchronized using abdominal pressure capsule sensor device

Group Type EXPERIMENTAL

S-nIMV

Intervention Type DEVICE

Synchronization of nasal breaths to infant's own respiratory effort

nIMV

non-synchronized nasal intermittent mandatory ventilation group

Group Type PLACEBO_COMPARATOR

S-nIMV

Intervention Type DEVICE

Synchronization of nasal breaths to infant's own respiratory effort

Interventions

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S-nIMV

Synchronization of nasal breaths to infant's own respiratory effort

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

Preterm infants recovering from respiratory failure with the following criteria were eligible for this study.

* Gestational age \<32 wks, those who are on invasive mechanical ventilation, recovering from RDS, and ready for extubation as judged by the clinical team.
* Informed consent available.

Exclusion Criteria

• Infants with major congenital anomalies involving the CNS, lung (i.e. lung hypoplasia, active air leaks) or the heart (ASD, VSD allowed), or known neuromuscular disease.

Eligible Sex

ALL

Accepts Healthy Volunteers

No