Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal High Frequency Ventilation | Experimental | Stable infants born at less than 1501 g who are at least 7 days old and undergoing nasal continuous positive airway pressure treatment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nasal high frequency ventilation | Other | use of the high frequency ventilation mode of the Infant Star ventilator via a single nasopharyngeal prong. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 hours |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Tarah T Colaizy, MD, MPH | University of Iowa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Iowa NICU | Iowa City | Iowa | 52242 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | mm Hg | 2 hours |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Tarah Colaizy | University of Iowa | tarah-colaizy@uiowa.edu |
Not provided
| ID | Term |
|---|---|
| D001261 | Pulmonary Atelectasis |
| D012131 | Respiratory Insufficiency |
| D001049 | Apnea |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | days |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | 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 | Posted | Mean | Standard Deviation | torr | 2 hours |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
Not provided
Not provided
Not provided
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |