Clinical trial NCT00296231: Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
Official title: Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Infant Respiratory Distress Syndrome
Respiratory Insufficiency
Apnea of Prematurity
Keywords: premature infants
very low birthweight infants
high frequency ventilation
nasal ventilation
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2006-02-24
Enrollment: 14
Sex: ALL
Minimum age (years): 7
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values
timeFrame: 2 hours
Secondary outcomes:
measure: Transcutaneous CO2 Measurements as a Trend Throughout Intervention
timeFrame: 2 hours
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: Children's Hospital of Iowa NICU
state: Iowa
Study officials:
affiliation: University of Iowa
name: Tarah T Colaizy, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: