AzTrials
AzTrials

Respiratory Distress Syndrome, NewbornPhase 1NCT00368485

Neural Control of Non-invasive Ventilation in the Preterm

A Phase 1 study of Respiratory Distress Syndrome, Newborn and Infant, Premature, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The present study will use a new type of respirator in premature babies who need help with their breathing. This new respirator uses signals from the baby's diaphragm - the most important breathing muscle - to control the timing and the amount of air that the baby needs. Read more about this study

Who is it for?
Ages 1 week to 6 months
Type of treatment
Medical device
How many people
24 participants
Where
1 siteCanada
Study dates
Aug 2006to Jun 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 week to 6 months
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Part 1: Preterm newborns (>1 week postnatal age, gestational age> 23 weeks, birth weight <1000g), intubated and mechanically ventilated, and breathing spontaneously. Infants should be breathing on a triggered mode of ventilation (SIMV, assist control, or pressure support) with the following ventilator parameters: assist control/pressure support < 20 cm H2O, PEEP4-7 cm H2O, SIMV rate< 30, FIO2<40%/.
  • Part 2:Newborns recovering from respiratory illness and deemed to be ready for elective extubation by their attending physician, intubated and mechanically ventilated, and breathing spontaneously.

Who cannot join

  • Protocols 1 and 2: Pneumothorax, degenerative neuromuscular disease, bleeding disorders, cardiovascular instability (defined as hypotension or need for treatment with volume expansion or inotropes in the previous 24 hours), cyanotic congenital cardiovascular disease, treatment with narcotics, phrenic nerve damage/diaphragm paralysis, esophageal perforation, use of high frequency oscillatory ventilation

Trial locations and contacts

1 site in 1 country.

Canada1 site
  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M5S1B6

Other trials in Canada

About this study

The present study will use a new type of respirator in premature babies who need help with their breathing. This new respirator uses signals from the baby's diaphragm - the most important breathing muscle - to control the timing and the amount of air that the baby needs. The goal of the study is to demonstrate that this new respirator can synchronize delivery of air to the baby's efforts, and that synchrony is maintained regardless of whether the baby is breathing with a tube or a mask.

Read the detailed description

There is an abundance of evidence in the literature suggesting that maintenance of spontaneous breathing with a synchronized mode of ventilatory assist, and the use of non-invasive interface to deliver the assist, has the potential to significantly improve neonatal respiratory care. Conventional modes of mechanical ventilation use pneumatic signals such as airway pressure, flow, or volume, which are dampened by respiratory muscle weakness, increased load (impaired respiratory mechanics), and leaks. In order to improve patient ventilator synchrony, further development over current technology is required.

This study deals with the implementation and clinical evaluation of neural control of mechanical ventilation in the neonatal intensive care unit. The goal is to demonstrate, in pre-term newborns with extremely low birth weight, that neural control of mechanical ventilation, using the electrical activity of the diaphragm (EAdi), can synchronize delivery of assist to the patient's inspiratory drive, and that synchrony is maintained regardless of the interface used. This proposal will introduce for the first time technology for neural triggering and cycling-off as well as neurally adjusted ventilatory assist (NAVA) in the treatment of pre-term infants.

In Project 1, the aim is to demonstrate that neural triggering and cycling-off (i.e. initiation and termination of ventilatory assist using EAdi) improve infant-ventilator synchrony, compared to conventional pneumatic trigger systems in pre-term infants with extremely low birth weight. It is hypothesized that neural triggering and cycling-off of mechanical ventilation improves infant-ventilator synchrony. This will be evaluated by comparing the infant's neural timings (inspiratory and expiratory) to ventilator timings, during conventional pressure support ventilation and during neural triggering and cycling-off. We expect that patient-ventilator synchrony will be improved in the neural mode, and that comfort will be lowest with increased asynchrony (conventional modes) and highest with improved infant-ventilator synchrony (neural triggering and cycling-off).

In Project 2, the aim is to demonstrate that administration of NAVA with invasive (endotracheal intubation) or non-invasive interface (nasal prongs) is equally efficient in terms of triggering and cycling-off. The hypothesis is that with NAVA, non-invasive ventilation with nasal prong is equally efficient as invasive ventilation. In premature infants deemed ready for extubation, NAVA will be implemented prior to and post-extubation (with single nasal prong). We anticipate that ventilatory assist will be delivered with full synchrony regardless of invasive or non-invasive delivery of assist, and that there should be no difference in the delays between the onset of EAdi and ventilatory assist and in the delays between peak of EAdi and cycling-off. We also expect that due to less airway resistance during non-invasive ventilation, peak applied pressures and diaphragm activation levels will be lower.

By improving patient-ventilator interaction and allowing use of a non-invasive patient-ventilator interface, neural control of mechanical ventilators has the potential to significantly reduce ventilator-related complications, reduce the incidence of lung injury, facilitate weaning from mechanical ventilation, and decrease the duration of stay in the intensive care unit and overall hospitalization. These issues can be addressed in future randomized clinical trials in the case that the present short-term work has a positive outcome.

Being tested
Neurally Controlled Mechanical Ventilation
Keywords
diaphragm electrical activity, non invasive ventilation, patient ventilator interaction
Medical subject headings
Respiratory Distress Syndrome, Newborn, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neurally Controlled Mechanical VentilationDevice

    A new mode of mechanical ventilation controlled by the electrical activity of the diaphragm (NAVA) will be used before and after extubation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. patient ventilator interaction

    Measured: 20 minutes

Secondary outcomes (2)
  1. breathing pattern

    Measured: 20 min

  2. diaphragm activity

    Measured: 20 min

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionJun 2008
  4. Study completionJun 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00368485
Sponsor's protocol ID
R21HD045047
Status last verified
Sep 2011
First submitted
22 Aug 2006
Last updated
21 Sep 2011
Results posted
No
Data monitoring committee
No

Publications

  • Sinderby C, Navalesi P, Beck J, Skrobik Y, Comtois N, Friberg S, Gottfried SB, Lindstrom L. Neural control of mechanical ventilation in respiratory failure. Nat Med. 1999 Dec;5(12):1433-6. doi: 10.1038/71012. No abstract available.

    PubMed 10581089

Questions about this trial

What is this clinical trial studying?

A Phase 1 study of Respiratory Distress Syndrome, Newborn and Infant, Premature, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

patient ventilator interaction (time frame: 20 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00368485, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2011.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in