UnknownNot Applicable

Adjusted Ventilatory Assist (NAVA-NIV) in Infants: Short-term Physiological Study

Italy15 participantsStarted 2013-03

Plain-language summary

Neurally Adjusted Ventilatory Assist (NAVA) is a new form of partial support wherein the machine applies positive pressure throughout inspiration in proportion to the electrical activity of the diaphragm (EAdi), as assessed by trans-esophageal electromyography. To test the hypothesis that NAVA could provide better patient-ventilator synchrony during NIV delivered by nasal-facial mask as compared to conventional flow-triggered PSV in infants with Acute Respiratory Failure.

Who can participate

Age range

1 Month – 2 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Infants aging \> 1 month and \< 2 yrs * ARF (PaO2/FiO2 \< 300 mmHg) * Accessory muscle recruitment * Respiratory Rate more than 2 SD related to age * Intact neuromuscular pathway to the diaphragm Exclusion Criteria: * Hemodynamic instability * Facial Surgery * Reduction in airway protection * Coma * Contraindication to insert the nasogastric catheter * Heart and lung transplant * Increase in PIC * Refusal of the parents or legal guardian * Enrolment in other research protocols

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Asynchrony Index

Timeframe: 60 minutes of each ventilatory trial, PSV or NAVA

Trial details

NCT IDNCT02043990

SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2014-03

Contact for this trial

Giovanna Chidini, MD

+39-2-55032242 giovannachid@libero.it

View on ClinicalTrials.gov More Acute Respiratory Failure trials