Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
Primary Purpose
Infant Respiratory Distress Syndrome, Respiratory Insufficiency, Apnea of Prematurity
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Nasal high frequency ventilation
Sponsored by
About this trial
This is an interventional treatment trial for Infant Respiratory Distress Syndrome focused on measuring premature infants, very low birthweight infants, high frequency ventilation, nasal ventilation
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
Sites / Locations
- Children's Hospital of Iowa NICU
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nasal High Frequency Ventilation
Arm Description
Stable infants born at less than 1501 g who are at least 7 days old and undergoing nasal continuous positive airway pressure treatment.
Outcomes
Primary Outcome Measures
pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values
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.
Secondary Outcome Measures
Transcutaneous CO2 Measurements as a Trend Throughout Intervention
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00296231
Brief Title
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
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2006 (undefined)
Primary Completion Date
February 2008 (Actual)
Study Completion Date
February 2008 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Tarah T Colaizy
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infant Respiratory Distress Syndrome, Respiratory Insufficiency, Apnea of Prematurity
Keywords
premature infants, very low birthweight infants, high frequency ventilation, nasal ventilation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nasal High Frequency Ventilation
Arm Type
Experimental
Arm Description
Stable infants born at less than 1501 g who are at least 7 days old and undergoing nasal continuous positive airway pressure treatment.
Intervention Type
Other
Intervention Name(s)
Nasal high frequency ventilation
Intervention Description
use of the high frequency ventilation mode of the Infant Star ventilator via a single nasopharyngeal prong.
Primary Outcome Measure Information:
Title
pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values
Description
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.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Transcutaneous CO2 Measurements as a Trend Throughout Intervention
Description
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
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Days
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarah T Colaizy, MD, MPH
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Iowa NICU
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
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Nasal High Frequency Ventilation in Preterm Infants: A Pilot Study
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