Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT00296231|
Recruitment Status : Completed
First Posted : February 24, 2006
Results First Posted : December 22, 2010
Last Update Posted : February 9, 2018
|Condition or disease||Intervention/treatment||Phase|
|Infant Respiratory Distress Syndrome Respiratory Insufficiency Apnea of Prematurity||Other: Nasal high frequency ventilation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||14 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study|
|Study Start Date :||February 2006|
|Primary Completion Date :||February 2008|
|Study Completion Date :||February 2008|
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.
Other: Nasal high frequency ventilation
use of the high frequency ventilation mode of the Infant Star ventilator via a single nasopharyngeal prong.
- pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values [ Time Frame: 2 hours ]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.
- Transcutaneous CO2 Measurements as a Trend Throughout Intervention [ Time Frame: 2 hours ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00296231
|United States, Iowa|
|Children's Hospital of Iowa NICU|
|Iowa City, Iowa, United States, 52242|
|Principal Investigator:||Tarah T Colaizy, MD, MPH||University of Iowa|