Respiratory Distress Syndrome in Premature InfantNCT03700606

Physiological Changes With High-Flow Nasal Cannula

A study testing High flow nasal cannula and Nasal CPAP in people with Respiratory Distress Syndrome in Premature Infant, run by Sharp HealthCare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 23 to 28 weeks
Conditions the study is for: Respiratory Distress Syndrome in Premature Infant
What is being tested?: High flow nasal cannula and Nasal CPAP
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteUnited States
Study dates: 15 Mar 2019to 14 Feb 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 23 to 28 weeks
All sexes
No healthy volunteers
Child

Who may be able to join

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

Show all 11Show fewer

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)

Who cannot join

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

Show all 10Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Sharp Mary Birch Hospital for Women & Newborns
San Diego, California, 92123

Other trials in United States

About this study

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

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).

Read the 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:

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.

Conditions: Respiratory Distress Syndrome in Premature Infant
Being tested: High flow nasal cannula, Nasal CPAP
Keywords: high flow nasal cannula, nasal cpap

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

High flow nasal cannulaProcedure or surgery
8 liters per minute of blended oxygen through Fisher Paykel Optiflow Jr 2 nasal prongs.
Nasal CPAPProcedure or surgery
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.

Study groups in NCT03700606
Study group	Role	What they receive
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. Receives: 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. Receives: Procedure: Nasal CPAP

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
Spatial center of tidal volume distribution in the thorax during ventilation
Measured: 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
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.
Measured: 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
Measurement of how much stretch the lung tissue undergoes during inspiration relative to baseline impedance
Measured: 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
Values <+3 → poor oxygenation relative to ventilation (inefficient V/Q matching) Values 4-6 → moderate efficiency Values >6 → good oxygenation efficiency relative to ventilation
Measured: Study Period 1 through 4

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Mar 201914 Feb 2022

First posted9 Oct 2018
Study start15 Mar 2019
Primary completion20 Dec 2021
Study completion14 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Respiratory Distress Syndrome in Premature InfantStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03700606
Sponsor's protocol ID: HFNC
Status last verified: May 2022
First submitted: 5 Oct 2018
Last updated: 17 Apr 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 40122991

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
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Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
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Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
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Not yet recruitingObservational study
Chest Ultrasound as Diagnostic and Prognostic Tool in Neonatal RDS
Respiratory Distress Syndrome, Newborn, Neonatal Respiratory Distress
RecruitingPhase 3
Safety and Efficacy of APC-0101 in Preterm Infants With Respiratory Distress Syndrome
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All Respiratory Distress Syndrome in Premature Infant trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Physiological Changes With High-Flow Nasal Cannula Compared to Nasal CPAP in Extremely Low Birth Weight Infants
ClinicalTrials.gov ID: NCT03700606
Acronym / sponsor ID: HFNC
Conditions: Respiratory Distress Syndrome in Premature Infant
Keywords: high flow nasal cannula, nasal cpap
Study type: Interventional
Recruitment status: Completed
Enrolment: 80 participants (actual)
Lead sponsor: Sharp HealthCareUniversity, hospital or other
Study start: 15 Mar 2019 (actual)
Primary completion: 20 Dec 2021 (actual)
Study completion: 14 Feb 2022 (actual)
First posted: 9 Oct 2018 (actual)
Results: Posted 17 Apr 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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.

Study design

Primary purpose: Supportive care
Allocation: Non-randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Nasal CPAP - Period 1	Active comparator	Procedure: Nasal CPAPEligible 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.
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	Procedure: Nasal CPAPAfter 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.

Who may qualify

Ages: 23 to 28 weeks
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (11 listed)

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

Key exclusion criteria (10 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
High flow nasal cannula8 liters per minute of blended oxygen through Fisher Paykel Optiflow Jr 2 nasal prongs.	Procedure or surgery	–
Nasal CPAPNasal 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.	Procedure or surgery	Nasal CPAP - Period 1, Nasal CPAP - Period 4

Primary outcome

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.

4 secondary outcomes

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.
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.
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.
Oxygenation Ratio
Time frame: Study Period 1 through 4

Results and safety

Results posted to the registry on 17 Apr 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Participants in HFNC Trial	80	78

Primary outcome: 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.. Mean (Standard Deviation). Unit: Percent of unventilated lung regions

Measure	Participants With Electrical Impedance Tomography Measurements During Each Period of Enrollment n = 78
Period 1	2.18 (0.33)
Period 2	2.32 (0.33)
Period 3	1.72 (0.35)
Period 4	2.17 (0.33)

Population analysed: In Period 3, twenty infants who met predefined HFNC failure criteria were returned immediately to nCPAP and therefore did not complete the scheduled 6-hour HFNC EIT assessment. All remaining participants contributed Period 3 data as available. In Period 4, EIT was collected for nearly all infants, although one participant had missing primary outcome data for percent of unventilated lung.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from enrollment through the end of the infant's hospital admission, up to 6 months of corrected gestational age. Adverse events are reported for the overall study population only, as all participants underwent the same study procedures in a crossover design and there were no differences in exposure between arms.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Participants in HFNC Trial	0 of 80 (0%)	48 of 80 (60%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40122991Katheria 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.

Related trials for Respiratory Distress Syndrome in Premature Infant

Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Recruiting
Ventilator Pressure and Optimization of Compliance and Hemodynamics
Bronchopulmonary Dysplasia, Pulmonary Hypertension Due to Lung Diseases and Hypoxia
Active, not recruiting
Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance
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RecruitingPhase 3
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Anup Katheria, MD principal investigator

Sharp HealthCare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing High flow nasal cannula and Nasal CPAP in people with Respiratory Distress Syndrome in Premature Infant, run by Sharp HealthCare at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03700606, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.