Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Hospital, Pulmonary |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/11/2018 |
| Start Date: | February 2006 |
| End Date: | February 2008 |
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.
through a nasal tube can lower blood carbon dioxide levels in stable preterm infants.
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.
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.
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
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