NCT03700606

Physiological Changes With High-Flow Nasal Cannula

Physiological Changes With High-Flow Nasal Cannula Compared to Nasal CPAP in Extremely Low Birth Weight Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Sharp HealthCare · Academic / Other
• Sex: All
• Age: 23 Weeks – 28 Weeks
• Healthy volunteers: Not accepted

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.

Conditions

• Respiratory Distress Syndrome in Premature Infant

Interventions

Type	Name	Description
PROCEDURE	High flow nasal cannula	8 liters per minute of blended oxygen through Fisher Paykel Optiflow Jr 2 nasal prongs.
PROCEDURE	Nasal 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.

Timeline

• Start date: 2019-03-15
• Primary completion: 2021-12-20
• Completion: 2022-02-14
• First posted: 2018-10-09
• Last updated: 2026-04-17
• Results posted: 2026-04-17

Locations

1 site across 1 country: United States