Nasal High-frequency Jet Ventilation (nHFJV) Following Extubation in Preterm Infants

NCT03558737 | Terminated Results DMC

• 1 other identifier: 109858
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 2

Brief Summary

Very low birth weight infants are at increased risk of requiring prolonged duration of mechanical ventilation and multiple intubations, both of which are risk factors for ventilator-induced lung injury and BPD. Thus, it is important to investigate respiratory support methods that are able to effectively oxygenate and ventilate these high risk preterm infants while reducing their risk of lung injury. Nasal high-frequency ventilation is one potential intervention that may decrease the risk of respiratory failure in very low birth weight infants. Small studies have shown effective respiratory support over short time periods in infants, however these studies use nasal high-frequency oscillatory ventilation. To the investigators' knowledge there is no published studies looking at the use of nasal high-frequency jet ventilation in this high risk population. Use of non-invasive high frequency ventilation (HFV) has been described as a rescue method following failure of other non-invasive ventilator modes or as a means to increase the success post-extubation. When used as invasive high frequency ventilation, high frequency oscillatory ventilation (HFOV) or high frequency jet ventilation (HFJV) utilize supraphysiologic respiratory rates and small tidal volumes which has been shown to inflict less lung injury than conventional modes of ventilation. Using a mechanical newborn lung model, nasal HFV has improved CO2 removal when compared to conventional NIPPV. Animal studies in the lab of Kurt Albertine have shown improved ventilation and oxygenation in the high frequency nasal ventilation group versus the mechanical ventilation group in a preterm lamb model leading towards better alveolar formation noted histologically. The investigators hypothesize that extubation of very preterm infants to nHFJV will significantly decrease the rates of reintubation compared to those infants extubated to NIPPV.

Conditions

Infant,Premature; Respiratory Failure; Respiratory Insufficiency; Respiratory Distress Syndrome in Premature Infant

Keywords

non-invasive high frequency ventilation (nHFJV); nasal intermittent positive pressure ventilation (NIPPV)

Outcome Measures

Primary Outcomes (1)

• 72 Hour Rate of Reintubation to Invasive Mechanical Ventilation

  The number of participants who needed to be reintubated during the first 72 hours of initiation of study intervention will be compared between both arms.

  72 hours

Secondary Outcomes (1)

• Rates of Moderate to Severe Bronchopulmonary Dysplasia (BPD)

  6 to 12 weeks

Study Arms (2)

Nasal high-frequency jet ventilation (nHFJV)

ACTIVE COMPARATOR

Other: Nasal high-frequency jet ventilation (nHFJV)

Nasal intermittent positive pressure ventilation (NIPPV)

ACTIVE COMPARATOR

Other: Nasal intermittent positive pressure ventilation (NIPPV)

Interventions

Nasal high-frequency jet ventilation (nHFJV) OTHER

Non-invasive high-frequency jet ventilation provided via the Bunnell Life Pulse high-frequency JET ventilator through a Rusch latex nasopharyngeal airway

Nasal high-frequency jet ventilation (nHFJV)

Nasal intermittent positive pressure ventilation (NIPPV) OTHER

Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs

Nasal intermittent positive pressure ventilation (NIPPV)

Eligibility Criteria

• Age: Up to 72 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• /7 to 28 6/7 weeks GA
• Intubated within 24 hours of life to synchronized intermittent mandatory ventilation (SIMV) or high frequency ventilation (HFV, includes HFOV or HFJV)
• Plan for extubation within 72 hours of life
• Infants intubated for surfactant replacement therapy via INSURE method (Intubation-Surfactant-Extubation) are eligible
• Consent obtained from parent/legal guardian

You may not qualify if:

• Major congenital and/or chromosomal anomalies
• Upper oropharyngeal anomalies

Sponsors & Collaborators

• University of Utah: lead

Study Sites (2)

University of Utah

Salt Lake City, Utah, 84112, United States

Location

Primary Children's Hospital

Salt Lake City, Utah, 84113, United States

Location

MeSH Terms

Conditions

Premature Birth; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiration Disorders; Respiratory Tract Diseases

Limitations and Caveats

This study was terminated early due to concerns related to the spontaneous intestinal perforation and abdominal distension that is inherent with all forms of nasal respiratory support. There is not enough data to run statistical analysis on and there is no way to make any meaningful conclusions.

Results Point of Contact

• Title: Bradley Yoder
• Organization: University of Utah

bradley.yoder@hsc.utah.edu

801-581-7052

Study Officials

• Bradley Yoder, MD

  University of Utah

  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: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Infants will be stratified by GA (24 0/7 to 25 6/7, 26 0/7 to 28 6/7) and randomized to either nHFJV or NIPPV

Study Record Dates

• First Submitted: April 25, 2018
• First Posted: June 15, 2018
• Study Start: April 1, 2019
• Primary Completion: February 8, 2022
• Study Completion: February 8, 2022
• Last Updated: July 24, 2024
• Results First Posted: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)