CompletedNot Applicable

NAVA in Infants With Acute Viral Bronchiolitis: A Feasibility Study

United Kingdom16 participantsStarted 2019-11-05

Plain-language summary

This exploratory intervention feasibility study aims to evaluate the use of a novel mode of ventilation known as Neurally adjusted ventilatory assist (NAVA) in infants with acute viral bronchiolitis. The main aims are: 1. To determine whether an optimal combination of NAVA support level and Positive End Expiratory Pressure (PEEP) exists that can: 1. maximise aspects of respiratory muscle unloading and 2. minimize air trapping 2. To evaluate the impact of two morphine infusion doses on comfort levels and respiratory drive (standard = 20mcg/kg/hr, low = 5mcg/kg/hr) during ventilation titration. Patients will act as their own control and will be randomly allocated to receive either standard or low dose morphine. They will receive the alternate dose on day 2. During each period of morphine dosing ventilation levels will be titrated and vital signs, respiratory parameters and comfort b scales will be recorded.

Who can participate

Age range

1 Day – 1 Year

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 aged \> 36 weeks corrected gestation and \< 1 year of age * Admitted to PICU with acute viral bronchiolitis within 48 hours of admission * Likely to require mechanical ventilation for \> 24 hours after enrolment * Able to pass a nasogastric tube Exclusion Criteria: * Apnoea as a primary reason for ventilation in the absence of respiratory symptoms * History of gastro-intestinal bleeds in previous 30 days or significant coagulopathy * Facial trauma or surgery * Known neuro-muscular disease or diaphragmatic palsy * Haemodynamic instability (requiring inotropes)

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

Changes to neuroventilatory efficiency when ventilation parameters are titrated

Timeframe: Measures will be recorded during the intervention

Changes to neuromuscular efficiency when ventilation parameters are titrated.

Timeframe: Measures will be recorded during the intervention

Changes to air trapping when ventilation parameters are titrated

Timeframe: Measures will be recorded immediately after each intervention

Change in Electrical activity of the diaphragm (Edi) when ventilator parameters are titrated

Timeframe: Measures will be recorded immediately after each intervention

Maintenance of patient comfort

Timeframe: Measures will be recorded immediately after each intervention

Changes in blood pressure

Timeframe: Measures will be recorded immediately after each intervention

Changes in heart rate

Trial details

NCT IDNCT05899894

SponsorGuy's and St Thomas' NHS Foundation Trust

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-02-26

View on ClinicalTrials.gov More Acute Viral Bronchiolitis trials