N/A N=80 Supportive Care

Physiological Changes With High-Flow Nasal Cannula

Respiratory Distress Syndrome in Premature Infant

Bottom Line

View on ClinicalTrials.gov: NCT03700606 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Percent of Unventilated Lung as Assessed by Electrical Impedance Tomography — 2.18; 2.32; 1.72; 2.17 Percent of unventilated lung regions

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: High flow nasal cannula (Procedure); Nasal CPAP (Procedure)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: Sharp HealthCare
Primary completion: Dec 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Unventilated Lung as Assessed by Electrical Impedance Tomography	2.18; 2.32; 1.72; 2.17	—
SECONDARY Geometric Center of Ventilation (CoV) - Ventral Dorsal	60.76; 59.98; 60.19; 60.01	—
SECONDARY End-expiratory Lung Impedance	9.68; 9.45; 10.12; 9.7	—
SECONDARY Relative Tidal Stetch	0.61; 0.62; 0.61; 0.60	—
SECONDARY Oxygenation Ratio	4.12; 3.96; 3.99; 4.07	—

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).

Eligibility Criteria

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 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03700606). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.