Respiratory Distress SyndromeNCT01277874
Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
A study testing Nasal CPAP and Oscillatory NCPAP in people with Respiratory Distress Syndrome and Prematurity, run by University of Utah at 3 sites in United States.
Trial summary
This study will seek to enroll neonates requiring Nasal Continuous Airway Pressure (NCPAP) respiratory support and randomize them to either oscillatory (Osc-NCPAP, study group) or non-oscillatory (NCPAP, control group) mode. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Respiratory Distress Syndrome, Prematurity
- What is being tested?
- Nasal CPAP and Oscillatory NCPAP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Up to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Newborn (0-28 days of age) admitted to Neonatal Intensive Care Unit (NICU)
- Ordered respiratory treatment of NCPAP
Who cannot join
- Major congenital defect
- Known or suspected chromosomal disorder
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Valley Children's Healthcare
Madera, California, 93636
Primary Children's Medical Center
Salt Lake City, Utah, 84113
University of Utah Health Sciences Center
Salt Lake City, Utah, 84132
About this study
This study will seek to enroll neonates requiring Nasal Continuous Airway Pressure (NCPAP) respiratory support and randomize them to either oscillatory (Osc-NCPAP, study group) or non-oscillatory (NCPAP, control group) mode. The goal of the research is to determine if Osc-NCPAP provides improved ventilation support compared to routine NCPAP, i.e. NCPAP without oscillations. This will be measured by need for change to ventilator support, improvement in pCO2 values, and reduction in respiratory rate and frequency of apnea during the period of NCPAP treatment. Other respiratory outcomes will also be compared, including time on NCPAP, time on High-Flow Nasal Cannula support following NCPAP, and time-averaged PiO2 from start of study to end of respiratory treatment.
- Conditions
- Respiratory Distress Syndrome, Prematurity
- Being tested
- Nasal CPAP, Oscillatory NCPAP
- Medical subject headings
- Respiratory Distress Syndrome, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal CPAPDevice
NCPAP is delivered via nasal prongs placed into infant's nares. It may be delivered via ventilator or by bubble.
Oscillatory NCPAPDevice
Also called Bird Industries
Bird Industries pneumatic diaphragm is attached to NCPAP patient circuit to provide oscillations.
| Study group | Role | What they receive |
|---|---|---|
| Nasal CPAP | Active comparator | Standard Nasal CPAP Receives: Device: Nasal CPAP |
| Oscillatory NCPAP | Active comparator | NCPAP will be given to infant via prongs in the infant's nose. A Bird Industries pneumatic oscillating diaphragm to drive a Bird Industries phasatron which is attached by T-connector to the NCPAP patient circuit. Receives: Device: Oscillatory NCPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP
Determine the physiologic respiratory stability (pCO2, respiratory rate, apnea frequency) during treatment with NCPAP
Measured: 2 months
Need for mechanical ventilation following the initiation of NCPAP.
The rate of mechanical ventilation following both Oscillating and Non-Oscillating groups.
Measured: 2 months
Secondary outcomes (2)
Total duration of non-invasive and invasive respiratory support in each study group.
Determine the total duration of non-invasive and invasive respiratory support in each study group.
Measured: 2 months
total amount of oxygen exposure in each study group. Total amount of oxygen exposure in each study group.
Determine the total amount of oxygen exposure in each study group.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2011 (estimated)
- Study startDec 2014
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Why it stopped: PI has left Institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donald Null, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01277874
- Sponsor's protocol ID
- 36738
- Status last verified
- Mar 2017
- First submitted
- 13 Jan 2011
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
- ClinicalTrials.gov ID
- NCT01277874
- Acronym / sponsor ID
- 36738
- Conditions
- Respiratory Distress Syndrome, Prematurity
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI has left Institution
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 17 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will seek to enroll neonates requiring Nasal Continuous Airway Pressure (NCPAP) respiratory support and randomize them to either oscillatory (Osc-NCPAP, study group) or non-oscillatory (NCPAP, control group) mode. The goal of the research is to determine if Osc-NCPAP provides improved ventilation support compared to routine NCPAP, i.e. NCPAP without oscillations. This will be measured by need for change to ventilator support, improvement in pCO2 values, and reduction in respiratory rate and frequency of apnea during the period of NCPAP treatment. Other respiratory outcomes will also be compared, including time on NCPAP, time on High-Flow Nasal Cannula support following NCPAP, and time-averaged PiO2 from start of study to end of respiratory treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nasal CPAP | Active comparator | Device: Nasal CPAPStandard Nasal CPAP |
| Oscillatory NCPAP | Active comparator | Device: Oscillatory NCPAPNCPAP will be given to infant via prongs in the infant's nose. A Bird Industries pneumatic oscillating diaphragm to drive a Bird Industries phasatron which is attached by T-connector to the NCPAP patient circuit. |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Newborn (0-28 days of age) admitted to Neonatal Intensive Care Unit (NICU)
- Ordered respiratory treatment of NCPAP
Key exclusion criteria (2 listed)
- Major congenital defect
- Known or suspected chromosomal disorder
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 |
|---|---|---|
| Nasal CPAPNCPAP is delivered via nasal prongs placed into infant's nares. It may be delivered via ventilator or by bubble. | Device | Nasal CPAP |
| Oscillatory NCPAPAlso: Bird IndustriesBird Industries pneumatic diaphragm is attached to NCPAP patient circuit to provide oscillations. | Device | Oscillatory NCPAP |
Primary outcome
Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP
Time frame: 2 months
Determine the physiologic respiratory stability (pCO2, respiratory rate, apnea frequency) during treatment with NCPAP
Need for mechanical ventilation following the initiation of NCPAP.
Time frame: 2 months
The rate of mechanical ventilation following both Oscillating and Non-Oscillating groups.
2 secondary outcomes
Total duration of non-invasive and invasive respiratory support in each study group.
Time frame: 2 months
total amount of oxygen exposure in each study group. Total amount of oxygen exposure in each study group.
Time frame: 2 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2026.
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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.
Donald Null, MD principal investigator
University of Utah
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal CPAP and Oscillatory NCPAP in people with Respiratory Distress Syndrome and Prematurity, run by University of Utah at 3 sites 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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 13 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2026.