Infant Respiratory Distress Syndrome, Respiratory Insufficiency, Apnea of Prematurity
Conditions
Keywords
premature infants, very low birthweight infants, high frequency ventilation, nasal ventilation
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.
Interventions
use of the high frequency ventilation mode of the Infant Star ventilator via a single nasopharyngeal prong.
Sponsors
Tarah T Colaizy
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Days to 3 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Transcutaneous CO2 Measurements as a Trend Throughout Intervention | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 14 |
| Total | 14 |
Baseline characteristics
| Characteristic | Nassal High Frequency Ventilation |
|---|---|
| Age, Categorical <=18 years | 14 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 39.5 days |
| Region of Enrollment United States | 14 participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 |
Outcome results
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.
Time frame: 2 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nassal High Frequency Ventilation | pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values | pre-nasal high frequency ventilation pCO2 | 50 mm Hg | Standard Deviation 6 |
| Nassal High Frequency Ventilation | pCO2 Measurements Post-intervention, as Compared to Pre-intervention Values | post-nasal high frequency ventilation pCO2 | 45 mm Hg | Standard Deviation 9 |
Comparison: Paired Student's t-test was used to compare pre and post intervention pCO2 values.p-value: 0.011t-test, 2 sided
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
Time frame: 2 hours
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Nassal High Frequency Ventilation | Transcutaneous CO2 Measurements as a Trend Throughout Intervention | pre-nasal high frequency TCOM | 47 torr | Standard Deviation 5 |
| Nassal High Frequency Ventilation | Transcutaneous CO2 Measurements as a Trend Throughout Intervention | post-nasal high frequency ventilation TCOM | 46 torr | Standard Deviation 5 |