Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study

Study Overview
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Brief Summary
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The purpose of this study is to test whether application of high frequency ventilation through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.

Detailed Description
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Prolonged mechanical ventilation is frequently needed to treat respiratory insufficiency and apnea in very low birthweight (VLBW, <1500 g) preterm infants. Endotracheal intubation and mechanical ventilation carry many risks including potentially fatal air leaks and ventilator-associated pneumonias. Less-invasive methods of respiratory support are needed to minimize these risks while supporting the convalescing preterm infant. We propose to test the effectiveness of nasal high-frequency ventilation (NHFV) in stable neonates with mild respiratory acidosis who are dependent on nasal continuous positive airway pressure for respiratory support (CPAP). Nasal high frequency ventilation may be effective in decreasing rates of reintubation for apnea or respiratory insufficiency in VLBW infants. We will enroll 60 stable VLBW infants who are currently being treated with nasal CPAP and who have mild respiratory acidosis. Twenty patients will be assigned to each ventilator under investigation. Nasal high frequency ventilation will be applied at the same mean airway pressure as the patients' previous CPAP support. The amplitude on nasal high frequency ventilation will be adjusted to achieve adequate shaking of the chest wall. Blood gas measurements, transcutaneous continuous pCO2 monitoring, continuous pulse oximetry, and chest x-rays will be used to assess safety and efficacy. Study power has been calculated to detect a difference (drop or rise) in partial pressure of CO2 (pCO2) equal to two-thirds of the standard deviation of pCO2 change reported in another study (van der Hoeven et al., 1998), which is a clinically relevant difference.

Official Title
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Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study

Conditions
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Infant Respiratory Distress Syndrome, Respiratory Insufficiency, Apnea of Prematurity

Intervention / Treatment
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* Other: Nasal high frequency ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: birthweight less than 1500 g Age >7 days Free of severe intraventricular hemorrhage (Grade III-IV) requiring nasal continuous positive airway pressure with a stable compensated respiratory acidosis (pH 7.25 - 7.45, pCO2 > 43 mm Hg), medically stable. Exclusion Criteria: major congenital anomalies

Ages Eligible for Study
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Minimum Age: 7 Days
Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nasal High Frequency Ventilation<br>Stable infants born at less than 1501 g who are at least 7 days old and undergoing nasal continuous positive airway pressure treatment. | Other: Nasal high frequency ventilation<br>* use of the high frequency ventilation mode of the Infant Star ventilator via a single nasopharyngeal prong.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values | Capillary partial pressure of CO2 (pCO2) was measured before and after 2 hours of nasal high frequency ventilatiion in a group of subjects. Each served as his/her own control. | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcutaneous CO2 Measurements as a Trend Throughout Intervention | We used a transcutaneous CO2 monitor (TCOM) as a safety device throughout the study. We analyzed the change in TCOM readings recorded every 30 minutes (5 measurements) to determine safety | 2 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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premature infants, very low birthweight infants, high frequency ventilation, nasal ventilation