Physiological Changes With High-Flow Nasal Cannula

Completed · Not applicable

Conditions studied: Respiratory Distress Syndrome in Premature Infant

In brief

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).

Key facts

Study ID

NCT03700606

Run by

Sharp HealthCare

People needed

80

Starts

2019-03-15

Expected to finish

2022-02-14

Last updated by the study team

2026-04-17

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

• Sharp Mary Birch Hospital for Women & Newborns — San Diego, California, United States

Full record on ClinicalTrials.gov

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