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 28 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 |
|---|---|---|
| Percent of Unventilated Lung as Assessed by Electrical Impedance Tomography | Primary outcome was measured during each study period: baseline on nCPAP, 30 minutes after starting HFNC, at 6 hours on HFNC or earlier if failure, and 60 minutes after returning to nCPAP. | Atelectasis will be calculated using the percentage of the lung fields that are not engaged in tidal volume.(VT) In Period 1 (nCPAP Baseline), infants on nCPAP at 5-7 cmH₂O in the supine position underwent up to 15 minutes of quiet-breathing EIT recording. In Period 2 (30 min on HFNC), infants were transitioned to HFNC at 8 L/min, and if tolerated, up to 15 minutes of EIT were collected at \~30 minutes. In Period 3 (6 hr on HFNC or earlier if failure), infants who tolerated HFNC underwent EIT at 6 hours; those meeting failure criteria returned immediately to nCPAP and were analyzed as Period 3 without a 6-hour EIT. In Period 4 (60 min after return to nCPAP), infants resumed nCPAP and up to 15 minutes of EIT were obtained about 60 minutes later. In period 4 one participant had missing primary outcome data and were analyzed as Period 4 without a 60 min return to nCPAP EIT measurement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Center of Ventilation (CoV) - Ventral Dorsal | This secondary outcome was measured during each study period: baseline on nCPAP, 30 minutes after starting HFNC, at 6 hours on HFNC or earlier if failure, and 60 minutes after returning to nCPAP. | Spatial center of tidal volume distribution in the thorax during ventilation |
| End-expiratory Lung Impedance | This secondary outcome was measured during each study period: baseline on nCPAP, 30 minutes after starting HFNC, at 6 hours on HFNC or earlier if failure, and 60 minutes after returning to nCPAP. | End-expiratory lung impedance was measured using electrical impedance tomography (EIT) to assess changes in end-expiratory lung volume. EELI reflects the sum of impedance values across all ventilated lung pixels at the end of expiration and provides an estimate of lung aeration. Values were derived from artifact-free tidal breaths captured during quiet breathing using the neonatal EIT belt and LuMon EIT system. |
| Relative Tidal Stetch | This secondary outcome was measured during each study period: baseline on nCPAP, 30 minutes after starting HFNC, at 6 hours on HFNC or earlier if failure, and 60 minutes after returning to nCPAP. | Measurement of how much stretch the lung tissue undergoes during inspiration relative to baseline impedance |
| Oxygenation Ratio | Study Period 1 through 4 | Values \<+3 → poor oxygenation relative to ventilation (inefficient V/Q matching) Values 4-6 → moderate efficiency Values \>6 → good oxygenation efficiency relative to ventilation |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAnup Katheria, MD
Sharp HealthCare
Participant flow
Recruitment details
Preterm infants born between 23 and 28+6 weeks' gestation were recruited from the Neonatal Intensive Care Unit. Infants were screened for eligibility based on respiratory stability on nCPAP, postmenstrual age ≤30 weeks, tolerance of routine handling, appropriate HFNC interface sizing, and recent stable blood gas. A total of eighty infants were enrolled in the study between March 2019 and December 2021, and written informed consent was obtained from parents or legal guardians before participation
Pre-assignment details
Two participants experienced unexpected data loss prior to analysis and were excluded from all study periods. During Period 3, 20 participants were unable to complete the planned 6-hour EIT assessment following transition to HFNC. Per protocol, these participants required immediate transition back to CPAP, precluding collection of the 6-hour time-point data. EIT data were obtained for all participants after re-establishing CPAP support for 60-minutes and included in the results.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 27 weeks |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 33 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| FiO2 settings prior to study enrollment | 21 percent (%) of inspired oxygen |
| Infant intubated any time prior to study enrollment | 55 participant |
| Infant's weight at time of study enrollment | 1015 grams |
| Postmenstrual age at the time of study enrollment | 29 weeks |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants |
| Race (NIH/OMB) More than one race | 6 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 35 Participants |
| Race (NIH/OMB) White | 24 Participants |
| Region of Enrollment United States | 78 Participants |
| Sex: Female, Male Female | 40 Participants |
| Sex: Female, Male Male | 38 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 80 |
| other Total, other adverse events | 48 / 80 |
| serious Total, serious adverse events | 0 / 80 |
Outcome results
None listed