Physiological Changes With High-Flow Nasal Cannula

NCT03700606 | Completed Results

• 1 other identifier: HFNC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Respiratory Distress Syndrome in Premature Infant

Keywords

high flow nasal cannula; nasal cpap

Outcome Measures

Primary Outcomes (1)

• Percent of Unventilated Lung as Assessed by Electrical Impedance Tomography

  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 without a 6-hour EIT. In Period 4 (60 min after return to nCPAP), infants resumed nCPAP and up to 15 minutes of EIT were obtained about 60 minutes later. In period 4 one participant had missing primary outcome data and were analyzed as Period 4 without a 60 min return to nCPAP EIT measurement.

  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.

Secondary Outcomes (4)

• Geometric Center of Ventilation (CoV) - Ventral Dorsal

  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

  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.

• Relative Tidal Stetch

  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.

• Oxygenation Ratio

  Study Period 1 through 4

Study Arms (3)

Nasal CPAP - Period 1

ACTIVE COMPARATOR

Eligible infants stable on high flow nasal cannula (nCPAP) therapy of 5-7 cm H20 achieved with a ventilator, an underwater "bubble" system, or a variable-flow device will be enrolled. A data acquisition cart will be placed at the subject's bedside to collect hemodynamic and respiratory parameters measured including: Heart rate (HR), blood pressure (BP), respiratory rate (RR), fraction of inspired oxygen (FiO2), transcutaneous carbon dioxide (TcCO2), and peripheral oxygen saturation (SpO2) via bedside monitoring devices. A neonatal chest belt, sized to the infant's chest circumference (nipple level) using warmed ultrasound gel applied to the belt beforehand, will collect regional lung volume measurements using electrical impedance tomography (EIT). Subject video recording will capture apnea events and the interventions used to resolve them such as positive pressure ventilation, repositioning, or stimulation. Data will be collected for 15 minutes on nCPAP.

Procedure: Nasal CPAP

High Flow Nasal Cannula (HFNC) - Period 2 & 3

ACTIVE COMPARATOR

Respiratory support will be crossed over to a HFNC Optiflow Jr 2 (Fisher \& Paykel Healthcare, Auckland, New Zealand) at a flow rate of 8 LPM. The size of the nasal cannula will be determined according to the manufacturer's instructions in order to maintain a leak at the nares. Identical data collection will occur for two 15 minute periods on HFNC, at the beginning and end of the six hour Study period.

Nasal CPAP - Period 4

ACTIVE COMPARATOR

After 6 hours of HFNC of 8 LPM, or sooner if the infant meets failure criteria, the infant will then be crossed back to the nCPAP device and at the settings previously utilized in Study Period 1. The infant will remain on the nCPAP device with identical data collection for 15 minutes. The total duration of the study and data collection will be 8 hours. The infant's body position will be similar for each lung volume measurement during the study periods.

Procedure: Nasal CPAP

Interventions

High flow nasal cannula PROCEDURE

8 liters per minute of blended oxygen through Fisher Paykel Optiflow Jr 2 nasal prongs.

Nasal CPAP PROCEDURE

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.

Nasal CPAP - Period 1; Nasal CPAP - Period 4

Eligibility Criteria

• Age: 23 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

Sponsors & Collaborators

• Sharp HealthCare: lead

Study Sites (1)

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, 92123, United States

Location

Related Publications (1)

• Katheria A, Ines F, Hough J, Rich W, Morales A, Sanjay S, Poeltler D, Finer N. Changes in lung aeration with high-flow nasal cannula compared to nasal CPAP in preterm infants. J Perinatol. 2025 Jun;45(6):817-822. doi: 10.1038/s41372-025-02267-4. Epub 2025 Mar 23.

  PMID: 40122991 DERIVED

Results Point of Contact

• Title: Dr. Anup Katheria
• Organization: Sharp Health Care: Neonatal Research Institute

Anup.Katheria@sharp.com

8589394170

Study Officials

• Anup Katheria, MD

  Sharp HealthCare

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director Neonatal Research Institute

Study Record Dates

• First Submitted: October 5, 2018
• First Posted: October 9, 2018
• Study Start: March 15, 2019
• Primary Completion: December 20, 2021
• Study Completion: February 14, 2022
• Last Updated: April 17, 2026
• Results First Posted: April 17, 2026

Record last verified: 2022-05

Locations

US (1)