Comparing NAVA Levels in Intubated and Recently Extubated Neonates to Determine Optimal Non-invasive Ventilatory Support

NCT ID: NCT02048280

Last Updated: 2015-07-30

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-12-31

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Neurally adjusted ventilatory assist (NAVA) is a mode of mechanical ventilation that uses the diaphragm's normal electrical activity to deliver a mechanically supported breath. The amount of support provided is determined in part by the NAVA level, where a higher NAVA level will provide higher level of support and unload more of the work of the diaphragm. The purpose of this study is to compare the optimal NAVA level in neonates while on mechanical ventilation while intubated and after being extubated.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Baseline measurements will be taken. The NAVA titration study will then be done. The NAVA level will be set at a starting value of 0.1 cm H2O/mcV and systematically increased by 0.5 cm H2O/mcV every three minutes to a maximum of 3 cmH2O/mcV. Once the NAVA titration study has been completed, the patient will be extubated. There will be a stabilization period following extubation (15-30 minutes), and then the NAVA titration study will be repeated.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Other Specified Respiratory Problems in Fetus or Neonate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intubated

NAVA level from 0.1 to 3

Group Type EXPERIMENTAL

NAVA level

Intervention Type PROCEDURE

Peak inspiratory pressure will be measured at each NAVA level

NAVA level

Intervention Type OTHER

Increase NAVA level every 3 minutes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

NAVA level

Peak inspiratory pressure will be measured at each NAVA level

Intervention Type PROCEDURE

NAVA level

Increase NAVA level every 3 minutes

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Neonates on NAVA ventilation

Exclusion Criteria

\-
Minimum Eligible Age

23 Weeks

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

ProMedica Health System

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Howard Stein, MD

Role: PRINCIPAL_INVESTIGATOR

Promedica Toledo Childrne's Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Promedica Toledo CHildren's Hospital NICU

Toledo, Ohio, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TCH02

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Non-invasive Ventilation in Preterm Infants
NCT05987800 ACTIVE_NOT_RECRUITING NA