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
Results First Received: October 29, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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.
No text entered.

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  
Number of Participants  
[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


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


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


No publications provided


Responsible Party: Tarah Colaizy, MD, MPH, University of Iowa
ClinicalTrials.gov Identifier: NCT00296231     History of Changes
Other Study ID Numbers: 200508714
Study First Received: February 22, 2006
Results First Received: October 29, 2010
Last Updated: November 23, 2010
Health Authority: United States: Institutional Review Board