Respiratory InsufficiencyNCT01531465
High Flow Nasal Cannula Versus Nasal Continuous Positive Airway Pressure
A study testing Pulmonary Function Testing & esophageal pressure monitoring and Pulmonary function testing and esophageal pressure in people with Respiratory Insufficiency, run by Christiana Care Health Services at 1 site in United States.
Trial summary
The purpose of this study is to compare two common methods of providing respiratory support: nasal continuous airway pressure and high flow nasal cannula to see what effect it has on babies breathing. Read more about this study
- Who is it for?
- Ages 2 days to 6 monthsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Insufficiency
- What is being tested?
- Pulmonary Function Testing & esophageal pressure monitoring and Pulmonary function testing and esophageal pressure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jan 2013
- 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 2 days to 6 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants who are between 28 and 40 weeks of corrected gestational age at the time of study entry
- Currently on high flow nasal cannula receiving 3 to 5 lpm or on nasal continuous positive airway pressure at 5 to 6 cmH2P with and FiO2 requirement </= 40% by the clinical care team for clinical care purposes.
- On current mode of support for >/= 12 hours and have been extubated from a mechanical ventilator for >/= 48 hours.
Who cannot join
- Infants with skeletal or neuromuscular disorders that affect the accuracy of RIP PFT measurements.
Trial locations and contacts
1 site in 1 country.
United States1 site
Christiana Care Health System - Christiana Hospital
Newark, Delaware, 19718
About this study
Official title: Pulmonary Function Testing in Infants With Respiratory Insufficiency While Receiving High Flow Nasal Cannula (HFNC) Versus Nasal Continuous Positive Airway Pressure (nCPAP)
The purpose of this study is to compare two common methods of providing respiratory support: nasal continuous airway pressure and high flow nasal cannula to see what effect it has on babies breathing. The investigators also will compare the effects of slightly changing the level of support these two different types of therapy on how easily your baby is breathing. Changes in the level of support and between these two respiratory support modalities are frequently done and are part of the routine care in the neonatal intensive care unit.
- Conditions
- Respiratory Insufficiency
- Being tested
- Pulmonary Function Testing & esophageal pressure monitoring, Pulmonary function testing and esophageal pressure
- Keywords
- Respiratory insufficiency, Infants, High Flow Nasal Cannula (HFNC), Nasal Continuous Positive Airway Pressure (NCPAP)
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Function Testing & esophageal pressure monitoringOther
Also called Pulmonary Function Testing, Esophageal pressure
Infants who are currently on NCPAP will have pulmonary function testing (PFTs)and esophageal pressure performed while on 2 different settings of NCPAP. These infants will then be transitioned HFNC and will undergo PFTs and esophageal pressure while on different HFNC settings. The infant will then be returned to NCPAP at the same settings they were on prior to any study interventions.
Pulmonary function testing and esophageal pressureOther
Also called Pulmonary Function Testing, Esophageal pressure
Infants who are currently on HFNC will have pulmonary function testing (PFTs) and esophageal pressure performed while on 2 different settings of HFNC. These infants will then be transitioned NCPAP and will undergo PFTs and esophageal pressure while on 2 different NCPAP settings. The infant will then be returned to HFNC at the same settings they were on prior to any study interventions.
| Study group | Role | What they receive |
|---|---|---|
| HFNC to NCPAP | Other | Infants who are currently on HFNC. Receives: Other: Pulmonary function testing and esophageal pressure |
| NCPAP to HFNC | Other | Infants who are currently on NCPAP. Receives: Other: Pulmonary Function Testing & esophageal pressure monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
lung compliance
Is there a difference in pulmonary function tests in infants with respiratory insufficiency being treated with high flow nasal cannula (HFNC) or nasal continuous positive airway pressure (NCPAP)?
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startJun 2011
- Primary completionOct 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InsufficiencyStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christiana Care Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Beatriz de Jongh, MD, Principal investigator, Christiana Care Health SystemsRobert Locke, DO, Study director, Christiana Care Health Services
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531465
- Sponsor's protocol ID
- 31073
- Status last verified
- Jun 2013
- First submitted
- 25 May 2011
- Last updated
- 4 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Function Testing in Infants With Respiratory Insufficiency While Receiving High Flow Nasal Cannula (HFNC) Versus Nasal Continuous Positive Airway Pressure (nCPAP)
- ClinicalTrials.gov ID
- NCT01531465
- Acronym / sponsor ID
- 31073
- Conditions
- Respiratory Insufficiency
- Keywords
- Respiratory insufficiency, Infants, High Flow Nasal Cannula (HFNC), Nasal Continuous Positive Airway Pressure (NCPAP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Christiana Care Health ServicesUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Feb 2012 (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.
The purpose of this study is to compare two common methods of providing respiratory support: nasal continuous airway pressure and high flow nasal cannula to see what effect it has on babies breathing. The investigators also will compare the effects of slightly changing the level of support these two different types of therapy on how easily your baby is breathing. Changes in the level of support and between these two respiratory support modalities are frequently done and are part of the routine care in the neonatal intensive care unit.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HFNC to NCPAP | Other | Other: Pulmonary function testing and esophageal pressureInfants who are currently on HFNC. |
| NCPAP to HFNC | Other | Other: Pulmonary Function Testing & esophageal pressure monitoringInfants who are currently on NCPAP. |
Who may qualify
- Ages
- 2 days to 6 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Infants who are between 28 and 40 weeks of corrected gestational age at the time of study entry
- Currently on high flow nasal cannula receiving 3 to 5 lpm or on nasal continuous positive airway pressure at 5 to 6 cmH2P with and FiO2 requirement </= 40% by the clinical care team for clinical care purposes.
- On current mode of support for >/= 12 hours and have been extubated from a mechanical ventilator for >/= 48 hours.
Key exclusion criteria (1 listed)
- Infants with skeletal or neuromuscular disorders that affect the accuracy of RIP PFT measurements.
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 |
|---|---|---|
| Pulmonary Function Testing & esophageal pressure monitoringAlso: Pulmonary Function Testing, Esophageal pressureInfants who are currently on NCPAP will have pulmonary function testing (PFTs)and esophageal pressure performed while on 2 different settings of NCPAP. These infants will then be transitioned HFNC and will undergo PFTs and esophageal pressure while on different HFNC settings. The infant will then be returned to NCPAP at the same settings they were on prior to any study interventions. | Other | NCPAP to HFNC |
| Pulmonary function testing and esophageal pressureAlso: Pulmonary Function Testing, Esophageal pressureInfants who are currently on HFNC will have pulmonary function testing (PFTs) and esophageal pressure performed while on 2 different settings of HFNC. These infants will then be transitioned NCPAP and will undergo PFTs and esophageal pressure while on 2 different NCPAP settings. The infant will then be returned to HFNC at the same settings they were on prior to any study interventions. | Other | HFNC to NCPAP |
Primary outcome
lung compliance
Time frame: 2 hours
Is there a difference in pulmonary function tests in infants with respiratory insufficiency being treated with high flow nasal cannula (HFNC) or nasal continuous positive airway pressure (NCPAP)?
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2013.
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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.
Beatriz de Jongh, MD principal investigator
Christiana Care Health Systems
Robert Locke, DO study director
Christiana Care Health Services
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Function Testing & esophageal pressure monitoring and Pulmonary function testing and esophageal pressure in people with Respiratory Insufficiency, run by Christiana Care Health Services 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 3 inclusion and 1 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 4 Jun 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
lung compliance (time frame: 2 hours). 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 4 Jun 2013.