Noninvasive NAVA Versus NIPPV in Low Birthweight Premature Infants

NCT03137225 | Terminated Results DMC FDA Device

• 1 other identifier: HM20005575
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

The investigator hypothesizes that in very low birth weight infants who require respiratory support via noninvasive ventilation, that synchronizing the ventilator breath with the baby's breath using neurally adjusted ventilatory assist (NAVA) will reduce the number and/or severity of apnea/bradycardia/desaturation episodes compared to nasal intermittent positive pressure ventilation (NIPPV).

Conditions

Noninvasive Ventilation; Low Birth Weight

Outcome Measures

Primary Outcomes (1)

• Number of Unexpected Events

  The number of isolated apneas, bradycardias and desaturations and the number of combined events will be compared by mode of ventilation.

  8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.

Secondary Outcomes (3)

• Synchronicity

  8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.

• Asynchronicity Counts

  During each four hour treatment segment

• Average Pressures

  8 hours - from placement on first study ventilation mode to the end of the second study ventilation mode.

Study Arms (2)

Nasal Intermittent Positive Pressure Ventilation (NIPPV) Mode

EXPERIMENTAL

After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to the other mode (NIPPV to NAVA), at the same PEEP (positive end-expiratory pressure) and respiratory rate. One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode (NAVA)

Device: Neurally Adjusted Ventilatory Assist; Device: Nasal Intermittent Positive Pressure Ventilation

Neurally Adjusted Ventilatory Assist (NAVA) Mode

EXPERIMENTAL

After a one hour stabilization period, during which small adjustments to the noninvasive settings can be made to clinically optimize the settings, the study will begin. A Nellcor pulse oximeter probe will be placed on an extremity to provide a continuous non-invasive downloadable measure of saturation (blood oxygen level) and heart rate. Data from the ventilator will be downloaded in real-time to a laptop. These data will be recorded for 4 hours continuously. After that, the ventilator will be switched to the other mode (NAVA to NIPPV), at the same PEEP and respiratory rate. One hour will be allowed to adjust the ventilator settings. Data will then be collected for 4 hours on the second ventilation mode (NIPPV)

Device: Neurally Adjusted Ventilatory Assist; Device: Nasal Intermittent Positive Pressure Ventilation

Interventions

Neurally Adjusted Ventilatory Assist DEVICE

Neurally Adjusted Ventilatory Assist delivered via RAM cannula .

Also known as: NAVA

Nasal Intermittent Positive Pressure Ventilation (NIPPV) Mode; Neurally Adjusted Ventilatory Assist (NAVA) Mode

Nasal Intermittent Positive Pressure Ventilation DEVICE

Nasal Intermittent Positive Pressure Ventilation delivered via RAM cannula

Also known as: NIPPV

Nasal Intermittent Positive Pressure Ventilation (NIPPV) Mode; Neurally Adjusted Ventilatory Assist (NAVA) Mode

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \< 1501 grams (VLBW (very low birth weight) infant)
• Patient must be receiving daily caffeine therapy for apnea
• On non-invasive ventilation, either NIPPV or non-invasive NAVA

You may not qualify if:

• No concerns for acute sepsis (i.e., blood cultures, if drawn, have been negative for 48 hours, and no active signs/symptoms of sepsis).
• No history of meningitis or seizures
• No signs of increased intracranial pressure, including bulging fontaneIle, presence of ventricular shunt device, or ventriculomegaly by most recent ultrasound.
• Presence of Grade III or IV intraventricular hemorrhage
• No cyanotic heart defects or clinically significant congenital heart disease. Will allow PDA (patent ductus arteriosus), PFO (patent foramen ovale), and mild to moderate ASD (atrial septal defect)/VSD (ventricular septal defect) as determined by pediatric cardiology.
• Non -English speaking legal representatives (parents)

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Related Publications (5)

• Tang S, Zhao J, Shen J, Hu Z, Shi Y. Nasal intermittent positive pressure ventilation versus nasal continuous positive airway pressure in neonates: a systematic review and meta-analysis. Indian Pediatr. 2013 Apr;50(4):371-6. doi: 10.1007/s13312-013-0122-0. Epub 2012 Oct 5.

  PMID: 23255684 RESULT

• Gizzi C, Montecchia F, Panetta V, Castellano C, Mariani C, Campelli M, Papoff P, Moretti C, Agostino R. Is synchronised NIPPV more effective than NIPPV and NCPAP in treating apnoea of prematurity (AOP)? A randomised cross-over trial. Arch Dis Child Fetal Neonatal Ed. 2015 Jan;100(1):F17-23. doi: 10.1136/archdischild-2013-305892. Epub 2014 Oct 15.

  PMID: 25318667 RESULT

• Petrof BJ, Jaber S, Matecki S. Ventilator-induced diaphragmatic dysfunction. Curr Opin Crit Care. 2010 Feb;16(1):19-25. doi: 10.1097/MCC.0b013e328334b166.

  PMID: 19935062 RESULT

• Stein H, Firestone K. Application of neurally adjusted ventilatory assist in neonates. Semin Fetal Neonatal Med. 2014 Feb;19(1):60-9. doi: 10.1016/j.siny.2013.09.005. Epub 2013 Nov 13.

  PMID: 24238745 RESULT

• Moerer O, Beck J, Brander L, Costa R, Quintel M, Slutsky AS, Brunet F, Sinderby C. Subject-ventilator synchrony during neural versus pneumatically triggered non-invasive helmet ventilation. Intensive Care Med. 2008 Sep;34(9):1615-23. doi: 10.1007/s00134-008-1163-z. Epub 2008 May 30.

  PMID: 18512045 RESULT

MeSH Terms

Interventions

Interactive Ventilatory Support

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Limitations and Caveats

Because only 1 participant was recruited and enrolled, results are not reported in order to protect the confidentiality of the participant.

Results Point of Contact

• Title: Henry J. Rozycki, MD
• Organization: Virginia Commonwealth University

henry.rozycki@vcuhealth.org

8048289602

Study Officials

• Henry J Rozycki, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomization - the order of modes will be assigned based on a random number table using a 5 block design to match the DSMB reporting needs.

Study Record Dates

• First Submitted: April 17, 2017
• First Posted: May 2, 2017
• Study Start: April 15, 2017
• Primary Completion: September 20, 2017
• Study Completion: June 30, 2019
• Last Updated: November 12, 2019
• Results First Posted: November 12, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)