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Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00296231
First Posted: February 24, 2006
Last Update Posted: December 22, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Iowa
Results First Submitted: October 29, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Infant Respiratory Distress Syndrome
Respiratory Insufficiency
Apnea of Prematurity
Intervention: Other: Nasal high frequency ventilation

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Nassal High Frequency Ventilation Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support

Participant Flow:   Overall Study
    Nassal High Frequency Ventilation
STARTED   14 
COMPLETED   14 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Nassal High Frequency Ventilation Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support

Baseline Measures
   Nassal High Frequency Ventilation 
Overall Participants Analyzed 
[Units: Participants]
 14 
Age 
[Units: Participants]
 
<=18 years   14 
Between 18 and 65 years   0 
>=65 years   0 
Age 
[Units: Days]
Median (Inter-Quartile Range)
 39.5 
 (18 to 147) 
Gender 
[Units: Participants]
 
Female   4 
Male   10 
Region of Enrollment 
[Units: Participants]
 
United States   14 


  Outcome Measures
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1.  Primary:   pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values   [ Time Frame: 2 hours ]

2.  Secondary:   Transcutaneous CO2 Measurements as a Trend Throughout Intervention   [ Time Frame: 2 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Tarah Colaizy
Organization: University of Iowa
e-mail: tarah-colaizy@uiowa.edu



Responsible Party: Tarah Colaizy, MD, MPH, University of Iowa
ClinicalTrials.gov Identifier: NCT00296231     History of Changes
Other Study ID Numbers: 200508714
First Submitted: February 22, 2006
First Posted: February 24, 2006
Results First Submitted: October 29, 2010
Results First Posted: December 22, 2010
Last Update Posted: December 22, 2010