Physiological Changes With High-Flow Nasal Cannula

Respiratory Distress Syndrome in Premature Infant Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03700606
• Other study ID #: HFNC
• Status: Completed
• Phase: N/A
• Start date: March 15, 2019
• Est. completion date: February 14, 2022

Study information

• Verified date: May 2022
• Source: Sharp HealthCare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: February 14, 2022
• Est. primary completion date: December 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 23 Weeks to 29 Weeks

Eligibility

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 <60 mmHg torr)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Respiratory Distress Syndrome
• Respiratory Distress Syndrome in Premature Infant
• Respiratory Distress Syndrome, Newborn

Intervention

Procedure:
• High flow nasal cannula
8 liters per minute of blended oxygen through Fisher Paykel Optiflow Jr 2 nasal prongs.
• 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.

Locations

Country	Name	City	State
United States	Sharp Mary Birch Hospital for Women & Newborns	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Sharp HealthCare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	% Unventilated Lung	Atelectasis will be calculated using the percentage of the lung fields that are not engaged in tidal volume.(VT)	Through study completion, an average of 30 days
Secondary	Geometric Center of Ventilation (CoV)	numeric value that describes the geographic point within the thorax that represents the statistical center of VT	Through study completion, an average of 30 days
Secondary	End-expiratory lung volume	% of total VT within 8 lung regions, relative change in uncalibrated aeration	Through study completion, an average of 30 days