Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study

This study has been completed.
Sponsor:
Information provided by:
University of Iowa
ClinicalTrials.gov Identifier:
NCT00296231
First received: February 22, 2006
Last updated: November 23, 2010
Last verified: November 2010

February 22, 2006
November 23, 2010
February 2006
February 2008   (final data collection date for primary outcome measure)
pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
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.
pCO2 measurements post-intervention, as compared to pre-intervention values
Complete list of historical versions of study NCT00296231 on ClinicalTrials.gov Archive Site
Transcutaneous CO2 Measurements as a Trend Throughout Intervention [ Time Frame: 2 hours ] [ Designated as safety issue: Yes ]
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
TCOM measurements as a trend throughout intervention
Not Provided
Not Provided
 
Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study

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.

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.

Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Infant Respiratory Distress Syndrome
  • Respiratory Insufficiency
  • Apnea of Prematurity
Other: Nasal high frequency ventilation
use of the high frequency ventilation mode of the Infant Star ventilator via a single nasopharyngeal prong.
Experimental: Nasal High Frequency Ventilation
Stable infants born at less than 1501 g who are at least 7 days old and undergoing nasal continuous positive airway pressure treatment.
Intervention: Other: Nasal high frequency ventilation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
14
February 2008
February 2008   (final data collection date for primary outcome measure)

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
Both
up to 3 Months
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00296231
200508714
Not Provided
Tarah Colaizy, MD, MPH, University of Iowa
University of Iowa
Not Provided
Principal Investigator: Tarah T Colaizy, MD, MPH University of Iowa
University of Iowa
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP