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

Utah System of Higher Education (USHE) logo

Utah System of Higher Education (USHE)

Status

Terminated

Conditions

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

Treatments

Other: Nasal high-frequency jet ventilation (nHFJV)
Other: Nasal intermittent positive pressure ventilation (NIPPV)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

4 patients

Sex

All

Ages

Under 72 hours old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

4 participants in 2 patient groups

Nasal high-frequency jet ventilation (nHFJV)
Active Comparator group
Treatment:
Other: Nasal high-frequency jet ventilation (nHFJV)
Nasal intermittent positive pressure ventilation (NIPPV)
Active Comparator group
Treatment:
Other: Nasal intermittent positive pressure ventilation (NIPPV)

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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