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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).
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nasal CPAP - Period 1 | Active Comparator | Eligible infants stable on high flow nasal cannula (nCPAP) therapy of 5-7 cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled. A data acquisition cart will be placed at the subject's bedside to collect hemodynamic and respiratory parameters measured including: Heart rate (HR), blood pressure (BP), respiratory rate (RR), fraction of inspired oxygen (FiO2), transcutaneous carbon dioxide (TcCO2), and peripheral oxygen saturation (SpO2) via bedside monitoring devices. A neonatal chest belt, sized to the infant's chest circumference (nipple level) using warmed ultrasound gel applied to the belt beforehand, will collect regional lung volume measurements using electrical impedance tomography (EIT). Subject video recording will capture apnea events and the interventions used to resolve them such as positive pressure ventilation, repositioning, or stimulation. Data will be collected for 15 minutes on nCPAP. |
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| High Flow Nasal Cannula (HFNC) - Period 2 & 3 | Active Comparator | Respiratory support will be crossed over to a HFNC Optiflow Jr 2 (Fisher & Paykel Healthcare, Auckland, New Zealand) at a flow rate of 8 LPM. The size of the nasal cannula will be determined according to the manufacturer's instructions in order to maintain a leak at the nares. Identical data collection will occur for two 15 minute periods on HFNC, at the beginning and end of the six hour Study period. | |
| Nasal CPAP - Period 4 | Active Comparator | After 6 hours of HFNC of 8 LPM, or sooner if the infant meets failure criteria, the infant will then be crossed back to the nCPAP device and at the settings previously utilized in Study Period 1. The infant will remain on the nCPAP device with identical data collection for 15 minutes. The total duration of the study and data collection will be 8 hours. The infant's body position will be similar for each lung volume measurement during the study periods. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High flow nasal cannula | Procedure | 8 liters per minute of blended oxygen through Fisher Paykel Optiflow Jr 2 nasal prongs. | ||
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Unventilated Lung as Assessed by Electrical Impedance Tomography | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Center of Ventilation (CoV) - Ventral Dorsal | Spatial center of tidal volume distribution in the thorax during ventilation | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anup Katheria, MD | Sharp HealthCare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sharp Mary Birch Hospital for Women & Newborns | San Diego | California | 92123 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40122991 | Derived | Katheria A, Ines F, Hough J, Rich W, Morales A, Sanjay S, Poeltler D, Finer N. Changes in lung aeration with high-flow nasal cannula compared to nasal CPAP in preterm infants. J Perinatol. 2025 Jun;45(6):817-822. doi: 10.1038/s41372-025-02267-4. Epub 2025 Mar 23. |
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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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants in HFNC Trial | Participants were preterm infants born at <29 weeks' gestation who were clinically stable on nasal continuous positive airway pressure (nCPAP) at 5-7 cmH₂O. Each infant underwent a crossover sequence of respiratory support modes. Baseline measurements were obtained on nCPAP (Period 1). Infants were then transitioned to high-flow nasal cannula (HFNC) at 8 L/min, with measurements collected at 30 minutes (Period 2). Infants who tolerated HFNC remained on HFNC for 6 hours for the next assessment, while those meeting predefined failure criteria were returned immediately to nCPAP and analyzed as Period 3 without a 6-hour HFNC measurement (Period 3). All infants were then returned to nCPAP, and measurements were collected approximately 60 minutes after resumption of support (Period 4). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Measurement (CPAP) |
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| 30 min post HFNC start |
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| 6 hours after initial transition to HFNC |
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| Period 4: Stabilization on CPAP |
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants in HFNC Trial | Participants were preterm infants born at <29 weeks' gestation who were clinically stable on nasal continuous positive airway pressure (nCPAP) at 5-7 cmH₂O. Each infant underwent a crossover sequence of respiratory support modes. Baseline measurements were obtained on nCPAP (Period 1). Infants were then transitioned to high-flow nasal cannula (HFNC) at 8 L/min, with measurements collected at 30 minutes (Period 2). Infants who tolerated HFNC remained on HFNC for 6 hours for the next assessment, while those meeting predefined failure criteria were returned immediately to nCPAP and analyzed as Period 3 without a 6-hour HFNC measurement (Period 3). All infants were then returned to nCPAP, and measurements were collected approximately 60 minutes after resumption of support (Period 4). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age is reported as gestational age at birth in weeks |
| 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 | Percent of Unventilated Lung as Assessed by Electrical Impedance Tomography | 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. | In Period 3, twenty infants who met predefined HFNC failure criteria were returned immediately to nCPAP and therefore did not complete the scheduled 6-hour HFNC EIT assessment. All remaining participants contributed Period 3 data as available. In Period 4, EIT was collected for nearly all infants, although one participant had missing primary outcome data for percent of unventilated lung. | Posted | Mean | Standard Deviation | Percent of unventilated lung regions | 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. |
Adverse events were collected from enrollment through the end of the infant's hospital admission, up to 6 months of corrected gestational age. Adverse events are reported for the overall study population only, as all participants underwent the same study procedures in a crossover design and there were no differences in exposure between arms.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants in HFNC Trial | Participants were preterm infants born at <29 weeks' gestation who were clinically stable on nasal continuous positive airway pressure (nCPAP) at 5-7 cmH₂O. Each infant underwent a crossover sequence of respiratory support modes. Baseline measurements were obtained on nCPAP (Period 1). Infants were then transitioned to high-flow nasal cannula (HFNC) at 8 L/min, with measurements collected at 30 minutes (Period 2). Infants who tolerated HFNC remained on HFNC for 6 hours for the next assessment, while those meeting predefined failure criteria were returned immediately to nCPAP and analyzed as Period 3 without a 6-hour HFNC measurement (Period 3). All infants were then returned to nCPAP, and measurements were collected approximately 60 minutes after resumption of support (Period 4). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Intraventricular Hemorrhage | General disorders | Systematic Assessment | Any grade intraventricular hemorrhage |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anup Katheria | Sharp Health Care: Neonatal Research Institute | 8589394170 | Anup.Katheria@sharp.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 11, 2019 | Jan 16, 2026 | Prot_000.pdf |
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| Nasal CPAP |
| Procedure |
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. |
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| End-expiratory Lung Impedance |
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. |
| 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. |
| Relative Tidal Stetch | Measurement of how much stretch the lung tissue undergoes during inspiration relative to baseline 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. |
| Oxygenation Ratio | Values <+3 → poor oxygenation relative to ventilation (inefficient V/Q matching) Values 4-6 → moderate efficiency Values >6 → good oxygenation efficiency relative to ventilation | Study Period 1 through 4 |
| Median |
| Inter-Quartile Range |
| weeks |
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| Sex: Female, Male | Sex assigned at birth | Count of Participants | Participants |
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| Race (NIH/OMB) | Race was self-reported by participant's parent at the time of informed consent | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity was self-reported by participant's parent | Count of Participants | Participants |
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| Region of Enrollment | All participants were enrolled in the United States | Number | Participants |
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| Postmenstrual age at the time of study enrollment | Gestational age at birth + Chronological age at time of study enrollment | Median | Inter-Quartile Range | weeks |
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| Infant's weight at time of study enrollment | Median | Inter-Quartile Range | grams |
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| Infant intubated any time prior to study enrollment | Number | participant |
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| FiO2 settings prior to study enrollment | FiO2 setting on CPAP obtained immediately before Period 1 EIT measurements | Median | Inter-Quartile Range | percent (%) of inspired oxygen |
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| Secondary | Geometric Center of Ventilation (CoV) - Ventral Dorsal | Spatial center of tidal volume distribution in the thorax during ventilation | In Period 3, twenty infants who met predefined HFNC failure criteria were returned immediately to nCPAP and therefore did not complete the scheduled 6-hour HFNC EIT assessment. All remaining participants contributed Period 3 data as available. In Period 4, EIT measurement of Spatial center of tidal volume distribution in the thorax during ventilation was successfully collected for all participants. | Posted | Mean | Standard Deviation | Percent of ventilation distribution | 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. |
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| Secondary | End-expiratory Lung Impedance | 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. | In Period 3, twenty infants who met predefined HFNC failure criteria were returned immediately to nCPAP and therefore did not complete the scheduled 6-hour HFNC EIT assessment. All remaining participants contributed Period 3 data as available. In Period 1,2, 4, EIT measurement of end-expiratory lung impedance were collected for all infants. | Posted | Mean | Standard Deviation | Lung aeration (arbitrary units) | 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. |
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| Secondary | Relative Tidal Stetch | Measurement of how much stretch the lung tissue undergoes during inspiration relative to baseline impedance | In Period 3, twenty infants who met predefined HFNC failure criteria were returned immediately to nCPAP and therefore did not complete the scheduled 6-hour HFNC EIT assessment. All remaining participants contributed Period 3 data as available. In Period 1,2, and 4, EIT measurement of relative tidal stretch were collected for all infants. | Posted | Mean | Standard Deviation | Percent of maximum impedance change | 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. |
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| Secondary | Oxygenation Ratio | Values <+3 → poor oxygenation relative to ventilation (inefficient V/Q matching) Values 4-6 → moderate efficiency Values >6 → good oxygenation efficiency relative to ventilation | In Period 3, twenty infants who met predefined HFNC failure criteria were returned immediately to nCPAP and therefore did not complete the scheduled 6-hour HFNC EIT assessment. All remaining participants contributed Period 3 data as available. In Period 1,2, and 4, EIT measurement of oxygen ratio were collected for all infants. | Posted | Mean | Standard Deviation | Ratio of SpO₂ to FiO₂ (unitless) | Study Period 1 through 4 |
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| 48 |
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| Periventricular Leukomalacia | General disorders | Systematic Assessment | diagnosed any time during hospitalization |
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| Sepsis | General disorders | Systematic Assessment |
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| Diagnosed Chronic Lung Disease | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | diagnosed any time during hospitalization |
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| Diagnosed Necrotizing Enterocolitis | Gastrointestinal disorders | Systematic Assessment | diagnosed any time during hospitalization |
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| Diagnosed Patent Ductus Arteriosus and required treatment | Cardiac disorders | Systematic Assessment |
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| Diagnosed Spontaneous Intestinal Perforation | Gastrointestinal disorders | Systematic Assessment |
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