NCT02480205

Brief Summary

There is currently a consensus that non-invasive ventilation (NIV) in preterm infants is preferred over intubation. There are two ways of delivering NIV in preterm infants, nasal continuous positive airway pressure (CPAP) or nasal intermittent positive pressure ventilation (NIPPV), where ventilator inflations are delivered intermittently over a fixed end-expiratory pressure. The synchronization in conventional mode is very difficult to obtain in premature infants. In all ventilation modes PEEP (end-expiratory pressure) is fixed. Considering that preterm infants are more likely to develop atelectasis, an active and ongoing management of the PEEP is very important to prevent de-recruitment. A new respiratory support system (NeuroPAP) was developed to address these issues (synchronization problems and control the PEEP). It uses the electrical activity of the diaphragm (EDI) to control the ventilator assist continuously, both during inspiration (principle of NAVA mode) and also during expiration (based on tonic Edi level).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2015

Completed
29 days until next milestone

First Posted

Study publicly available on registry

June 24, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2017

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

1.5 years

First QC Date

May 26, 2015

Last Update Submit

January 30, 2017

Conditions

Respiratory Failure

Keywords

CPAPNIVNIPPVEdi

Outcome Measures

Primary Outcomes (7)

  • Time effectively spent with NeuroPAP mode activated during the NeuroPAP period

    Percentage

    up to 30 minutes after reinstitution of the conventional NIPPV

  • Number of interruption of NeuroPAP during the NeuroPAP period

    Number of interruption per patients

    up to 30 minutes after reinstitution of the conventional NIPPV

  • Change in respiratory rates between standard NIV andNeuroPAP

    % of change

    up to 30 minutes after reinstitution of the conventional NIPPV

  • Change in cardiac rates between standard NIV andNeuroPAP

    % of change

    up to 30 minutes after reinstitution of the conventional NIPPV

  • Change in blood pressure between standard NIV andNeuroPAP

    % of change

    up to 30 minutes after reinstitution of the conventional NIPPV

  • Change in SpO2 between standard NIV andNeuroPAP

    % of change

    up to 30 minutes after reinstitution of the conventional NIPPV

  • Change in TcPCO2 between standard NIV andNeuroPAP

    % of change

    up to 30 minutes after reinstitution of the conventional NIPPV

Secondary Outcomes (9)

  • Time spent in asynchrony between standard NIV and NeuroPAP

    up to 30 minutes after reinstitution of the conventional NIPPV

  • Change in trigger delays (ms) between standard NIV andNeuroPAP

    up to 30 minutes after reinstitution of the conventional NIPPV

  • Change in non assisted breaths (wasted efforts) between standard NIV andNeuroPAP

    up to 30 minutes after reinstitution of the conventional NIPPV

  • Change in autotriggered breaths between standard NIV and NeuroPAP

    up to 30 minutes after reinstitution of the conventional NIPPV

  • Change in Mean Airway pressure (cmH2O) between standard NIV and NeuroPAP

    up to 30 minutes after reinstitution of the conventional NIPPV

  • +4 more secondary outcomes

Study Arms (1)

NeuroBox to deliver the NeuroPAP

EXPERIMENTAL
Device: NeuroBox to deliver the NeuroPAP

Interventions

NeuroBox to deliver the NeuroPAPDEVICE

The patients will be studied during the following conditions: * On conventional NIPPV device with the clinically prescribed settings (30 min) * With NeuroPAP and no change of Pmin (=peep) (60 min) * With NeuroPAP and adjusted Pmin (decreased by 2 cmH2O) (60 min) * During CPAP delivered with NeuroPAP device (15 min) * Again with original NIPPV device and settings for 30 minutes

NeuroBox to deliver the NeuroPAP

Eligibility Criteria

Age3 Days - 1 Month
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Preterm infants, \>26 0/7 and \< 34 weeks GA, at least 3 days old and younger than 1 month,
  • on NIPPV with settings in the range : Maximal inspiratory pressure (total, including PEEP) \< 20 cmH2O, and PEEP : 5-7 cmH2O,
  • with FiO2 \<40%, and stable.

You may not qualify if:

  • Suspected or proven pneumothorax
  • Patient on high-flow nasal cannula or nasal continuous positive airway pressure (nCPAP)
  • Infants with severe recurring apnea
  • Recent worsening of respiratory status with increase work of breathing, recent increase in FiO2, or linked with a suspected sepsis
  • Contraindications to the placement of a new nasogastric tube (e.g. severe coagulation disorder, malformation or recent surgery in cervical, nasopharyngeal or esophageal regions)
  • Hemodynamic instability requiring inotropes.
  • Severe respiratory instability requiring imminent intubation according to the attending physician, or FiO2 \> 45%, or PaCO2 \> 65 mmHg on blood gas in the last hour.
  • Patient for whom a limitation of life support treatments is discussed or decided.
  • Refusal by the treating physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Justine's Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (1)

  • Rochon ME, Lodygensky G, Tabone L, Essouri S, Morneau S, Sinderby C, Beck J, Emeriaud G. Continuous neurally adjusted ventilation: a feasibility study in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2020 Nov;105(6):640-645. doi: 10.1136/archdischild-2019-318660. Epub 2020 Apr 8.

    PMID: 32269148DERIVED

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Guillaume Emeriaud, MD, PhD

    St. Justine's Hospital

    PRINCIPAL INVESTIGATOR

  • Gregory Lodygensky, MD, PhD

    St. Justine's Hospital

    PRINCIPAL INVESTIGATOR

  • Jennifer Beck, PhD

    Li Ka Shing Knowledge Institute. St. Michael's Hospital

    PRINCIPAL INVESTIGATOR

  • Christer Sinderby, PhD

    Li Ka Shing Knowledge Institute. St. Michael's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

May 26, 2015

First Posted

June 24, 2015

Study Start

August 1, 2015

Primary Completion

January 30, 2017

Study Completion

January 30, 2017

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

CA(1)