Respiratory Distress Syndrome in Premature Infant
Conditions
Keywords
high flow nasal cannula, nasal cpap
Brief summary
To measure changes in physiologic parameters in extremely low birthweight (ELBW) infants on high-flow nasal cannula compared to nasal continuous positive airway pressure (nCPAP).
Detailed description
After informed consent is obtained, eligible infants who are stable on nCPAP therapy of 5-7 cm H20 achieved with a ventilator, an underwater bubble system, or a variable-flow device will be enrolled. All subjects will have physiologic data and electrical impedance tomography collected at: 1. Baseline nCPAP for 15 minutes 2. Upon transition to high flow nasal cannula at 8 LPM for 6 hours. Data collection is obtained after infant is calm for 15 minutes at the beginning and end of this 6 hour period 3. Then upon return to baseline NCPAP for a final 15 minutes of data collection.
Interventions
PROCEDUREHigh flow nasal cannula
8 liters per minute of blended oxygen through Fisher Paykel Optiflow Jr 2 nasal prongs.
PROCEDURENasal CPAP
Nasal continuous positive airway pressure of 5-7 cm/H20 delivered using Ventilator or bubble cpap device through short nasal prongs or a nasal face mask.
Sponsors
Sharp HealthCare
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 29 Weeks
Healthy volunteers
No
Inclusion criteria
* 23 to 28+6 weeks gestational age at birth * Corrected gestational age less than or equal to 30 weeks * Over 72 hours of life * Stable on Nasal CPAP of 5-7cm H20 * Hemodynamically stable * Tolerating routine handling * Nares size appropriate for Fisher & Paykel Optiflow Jr 2 HFNC size XS or small * Successfully extubated for 12 hours after administration of surfactant * Caffeine Citrate at a maintenance dose of 5 to 10 mg /kg * Transcutaneous monitoring in place * Stable blood gas (pH\>/= 7.25 and PaCO2 \<60 mmHg torr)
Exclusion criteria
* Prior pneumothorax or evidence of pulmonary interstitial emphysema. * Prior or current pulmonary hemorrhage * Congenital airway malformations * Major cardiopulmonary malformations * Congenital Diaphragmatic hernia or untreated bowel obstruction * Poor respiratory drive unresponsive to CPAP therapy * Requirement of a nCPAP of \>8 cmH20 or FiO2 \> 0.3 to maintain oxygen saturations between 90-95 percent. * Receiving positive pressure breaths or SIPAP on prongs * Conflicting clinical trial * Clinically unstable per physician discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| % Unventilated Lung | Through study completion, an average of 30 days | Atelectasis will be calculated using the percentage of the lung fields that are not engaged in tidal volume.(VT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Center of Ventilation (CoV) | Through study completion, an average of 30 days | numeric value that describes the geographic point within the thorax that represents the statistical center of VT |
| End-expiratory lung volume | Through study completion, an average of 30 days | % of total VT within 8 lung regions, relative change in uncalibrated aeration |
Countries
United States
Outcome results
None listed