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

Not Applicable

Terminated

• Conditions: Respiratory Distress Syndrome in Premature Infant; Infant,Premature; Respiratory Failure; Respiratory Insufficiency
• Interventions: Other: Nasal intermittent positive pressure ventilation (NIPPV); Other: Nasal high-frequency jet ventilation (nHFJV)

• Registration Number: NCT03558737
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-25
• Study First Submitted QC: 2018-06-14
• Study First Posted: 2018-06-15
• Study Start: 2019-04-01
• Primary Completion: 2022-02-08
• Study Completion: 2022-02-08
• Results First Submitted: 2023-11-27
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-23
• Last Update Submitted: 2024-07-23
• Results First Posted: 2024-07-24
• Last Update Posted: 2024-07-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

• 24 0/7 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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Nasal intermittent positive pressure ventilation (NIPPV)	Nasal intermittent positive pressure ventilation (NIPPV)	-
Nasal high-frequency jet ventilation (nHFJV)	Nasal high-frequency jet ventilation (nHFJV)	-

Primary Outcome Measures

Name	Time	Method
72 Hour Rate of Reintubation to Invasive Mechanical Ventilation	72 hours	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.

Secondary Outcome Measures

Name	Time	Method
Rates of Moderate to Severe Bronchopulmonary Dysplasia (BPD)	6 to 12 weeks	The number of infants diagnosed with moderate to severe BPD evaluated at 36 weeks corrected gestational age as defined by the 2001 NICHD Consensus Conference, with and without altitude correction will be compared between both arms

Trial Locations

Locations (2)

Primary Children's Hospital; 🇺🇸 Salt Lake City, Utah, United States

University of Utah; 🇺🇸 Salt Lake City, Utah, United States