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Completed

NCT Number: NCT03700606

Physiological Changes With High-Flow Nasal Cannula

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).

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Key information

Conditions

Respiratory Distress Syndrome in Premature Infant

Age range

23 week–28 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sharp Mary Birch Hospital for Women & Newborns

San Diego, California, 92123, United States

About this study

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:

  • Baseline nCPAP for 15 minutes
  • 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
  • Then upon return to baseline NCPAP for a final 15 minutes of data collection.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Percent of Unventilated Lung as Assessed by Electrical Impedance Tomography

    Time frame: 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.

    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.

Secondary outcomes

  1. Geometric Center of Ventilation (CoV) - Ventral Dorsal

    Time frame: 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.

    Spatial center of tidal volume distribution in the thorax during ventilation

  2. End-expiratory Lung Impedance

    Time frame: 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 was measured using electrical impedance tomography (EIT) to assess changes in end-expiratory lung volume. EELI reflects the sum of impedance values across all ventilated lung pixels at the end of expiration and provides an estimate of lung aeration. Values were derived from artifact-free tidal breaths captured during quiet breathing using the neonatal EIT belt and LuMon EIT system.

  3. Relative Tidal Stetch

    Time frame: 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.

    Measurement of how much stretch the lung tissue undergoes during inspiration relative to baseline impedance

  4. Oxygenation Ratio

    Time frame: Study Period 1 through 4

    Values <+3 → poor oxygenation relative to ventilation (inefficient V/Q matching) Values 4-6 → moderate efficiency Values >6 → good oxygenation efficiency relative to ventilation

Sponsors and collaborators

Lead sponsor

Sharp HealthCare

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Oct 9, 2018
Registry last updated
Apr 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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