Adults 23 Weeks to 28 Weeks, any sex, with Respiratory Distress Syndrome in Premature Infant. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percent of Unventilated Lung as Assessed by Electrical Impedance TomographyPrimary· 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
Period 1
Group
Value
95% CI
Participants With Electrical Impedance Tomography Measurements During Each Period of Enrollment
2.18
± 0.33
Period 2
Group
Value
95% CI
Participants With Electrical Impedance Tomography Measurements During Each Period of Enrollment
2.32
± 0.33
Period 3
Group
Value
95% CI
Participants With Electrical Impedance Tomography Measurements During Each Period of Enrollment
1.72
± 0.35
Period 4
Group
Value
95% CI
Participants With Electrical Impedance Tomography Measurements During Each Period of Enrollment
2.17
± 0.33
Geometric Center of Ventilation (CoV) - Ventral DorsalSecondary· 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
Period 1
Group
Value
95% CI
Participants in HFNC Trial
60.76
± 0.31
Period 2
Group
Value
95% CI
Participants in HFNC Trial
59.98
± 0.31
Period 3
Group
Value
95% CI
Participants in HFNC Trial
60.19
± 0.34
Period 4
Group
Value
95% CI
Participants in HFNC Trial
60.01
± 0.32
End-expiratory Lung ImpedanceSecondary· 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.
Period 1
Group
Value
95% CI
Participants in HFNC Trial
9.68
± 0.39
Period 2
Group
Value
95% CI
Participants in HFNC Trial
9.45
± 0.39
Period 3
Group
Value
95% CI
Participants in HFNC Trial
10.12
± 0.42
Period 4
Group
Value
95% CI
Participants in HFNC Trial
9.7
± 0.39
Relative Tidal StetchSecondary· 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
Period 1
Group
Value
95% CI
Participants in HFNC Trial
0.61
± 0.005
Period 2
Group
Value
95% CI
Participants in HFNC Trial
0.62
± 0.006
Period 3
Group
Value
95% CI
Participants in HFNC Trial
0.61
± 0.006
Period 4
Group
Value
95% CI
Participants in HFNC Trial
0.60
± 0.005
Oxygenation RatioSecondary· 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
Period 1
Group
Value
95% CI
Participants in HFNC Trial
4.12
± 0.08
Period 2
Group
Value
95% CI
Participants in HFNC Trial
3.96
± 0.08
Period 3
Group
Value
95% CI
Participants in HFNC Trial
3.99
± 0.09
Period 4
Group
Value
95% CI
Participants in HFNC Trial
4.07
± 0.08
Adverse events — posted to ClinicalTrials.gov
Time frame: 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..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Participants in HFNC Trial
Serious: 0/80 (0%)
Deaths: 0/80
Other adverse events (7 terms — click to expand)
Reaction
System
Participants in HFNC Trial
Diagnosed Patent Ductus Arteriosus and required treatment
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).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT06069817 — Impact of High Flow Therapy on Complications Related to Airway Stenting
· NA
· unknown
NCT05918575 — Postextubation Use of Noninvasive Respiratory Support in Severely Obese Patients
· NA
· recruiting
NCT05532033 — High Flow Nasal Cannula and Diaphragmatic Function
· NA
· completed
NCT04842253 — HFNC Vs LFNC in Patients with AF Undergoing RFCA Under Deep Sedation.
· NA
· terminated
NCT04849520 — High Flow Nasal Cannula for Safe Apnea
· NA
· completed
Other recruiting trials for Respiratory Distress Syndrome in Premature Infant
Currently open trials in the same condition.
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· recruiting
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· NA
· recruiting
NCT06554522 — Pragmatic Evaluation of Respiratory Distress Syndrome Treatment in Africa
· Phase 4
· recruiting
NCT06557551 — Prophylactic Surfactant by Thin Endotracheal Catheter for Preterm Infants At Birth: the ProTeCt Trial
· NA
· recruiting
NCT06642285 — Effect of Implementing Evidence Based Practices on Prevention of Associated Nasal Pressure Injuries Among Preterm Neonat
· NA
· recruiting
Other Sharp HealthCare trials
Trials by the same sponsor.
NCT07301385 — Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety a
· NA
· recruiting
NCT07176117 — Surfactant Using a Supraglottic Airway Device in Late Preterm to Early Term Infants
· NA
· not yet recruiting
NCT07028359 — Sharp Health Companion App for Cataract Surgery Preparation and Recovery
· NA
· completed
NCT04413097 — Delayed Cord Clamping With Oxygen In Extremely Low Gestation Infants
· NA
· active not recruiting
NCT04848727 — Detection of Atelectasis or Pneumothorax and Resolution With Electrical Impedance Tomography (EIT) in Newborn Infants
· completed
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Sharp HealthCare
Last refreshed: 17 April 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03700606.