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Physiologic Comparison Between NIV-NAVA and PS in Preterm Infants

NCT ID: NCT01877720

Last Updated: 2015-12-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-04-30

Brief Summary

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Neurally adjusted ventilatory assist (NAVA) has been shown to improve patient- ventilator interaction and reduce asynchronies. This is a short-term physiologic comparison between PSV (pressure support ventilation) and NAVA in delivering noninvasive ventilation through a nasal cannula, in premature infants postextubation. Patients will undergo a 30-min crossover trial of noninvasive PSV and NAVA, 15 minutes each. Diaphragm electrical activity (EAdi)and airway pressure (Paw) are recorded to derive neural and mechanical respiratory rate and timing, inspiratory trigger delays time of synchrony between diaphragm contraction and ventilator assistance, and the asynchrony index (AI).

Detailed Description

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Conditions

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Noninvasive Neurally Adjusted Ventilatory Assist and Pressure Support in Preterm Infants

Keywords

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Preterm infant less than 32 weeks of gestation age intubated more than 48 hours after birth postextubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NAVA-PS

noninvasive NAVA first for 15 minutes and then PSV for 15 minutes

Group Type EXPERIMENTAL

noninvasive respiratory support with NAVA mode and PSV

Intervention Type DEVICE

PS-NAVA

noninvasive PSV first for 15 minutes and then NAVA for 15 minutes

Group Type EXPERIMENTAL

noninvasive respiratory support with NAVA mode and PSV

Intervention Type DEVICE

Interventions

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noninvasive respiratory support with NAVA mode and PSV

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* preterm infants less than 32 weeks of gestational age
* intubated more than 48 hours after birth
* subjected to extubation with minimal ventilator setting (mean airway pressure \< 7cmH2O + peak inspiratory pressure \< 13 cmH2O + FiO2 \< 0.4 + respiratory rate \< 35/min)
* with informed consent from parents

Exclusion Criteria

* with major congenital anomalies
* use of sedative or anesthetic drugs
* hemodynamic instability
* grade 3 or higher intraventricular hemorrhage
* phrenic nerve palsy
Minimum Eligible Age

3 Days

Maximum Eligible Age

3 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rotary

UNKNOWN

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Han-Suk Kim

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Han-Suk Kim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Bundang Hospital

Bundang, Gyeonggi-do, South Korea

Site Status

Seoul National University Children's Hospital

Seoul, , South Korea

Site Status

Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Lee J, Kim HS, Jung YH, Shin SH, Choi CW, Kim EK, Kim BI, Choi JH. Non-invasive neurally adjusted ventilatory assist in preterm infants: a randomised phase II crossover trial. Arch Dis Child Fetal Neonatal Ed. 2015 Nov;100(6):F507-13. doi: 10.1136/archdischild-2014-308057. Epub 2015 Jul 15.

Reference Type DERIVED
PMID: 26178463 (View on PubMed)

Other Identifiers

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NIV-NAVA Physiologic Study

Identifier Type: -

Identifier Source: org_study_id