Respiratory DistressPhase 1NCT01939067
Infant Pulmonary Mechanics: High Flow Nasal Cannula Versus Nasal CPAP
A Phase 1 study testing Heated Humidified High Flow Nasal Cannula and Nasal Continuous Positive Airway Pressure in people with Respiratory Distress and Lung Injury, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
This study is designed to evaluate the effect of heated humidified high flow nasal cannula (HHHFNC) as compared to noninvasive nasal continuous positive airway pressure (NCPAP) on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support. Read more about this study
- Who is it for?
- Ages 2 to 72 hoursHealthy volunteers can take part
- Conditions the study is for
- Respiratory Distress, Lung Injury
- What is being tested?
- Heated Humidified High Flow Nasal Cannula and Nasal Continuous Positive Airway Pressure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Mar 2014
- Phase
- Phase 1
- 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 to 72 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Birth weight greater than or equal to 1000 grams.
- Gestational age at birth between 28 weeks and 37 weeks (28 0/7 to 37 6/7 weeks inclusive).
- Candidate for non-invasive respiratory support as a result of:
- An intention to manage the infant with non-invasive (no endotracheal tube) respiratory support.
- An intention to extubate an infant being managed with intubated respiratory support to non-invasive respiratory support.
- Subjects must have a guardian or acceptable surrogate capable of giving consent on his/her behalf.
Who cannot join
- Birth weight less than 1000 grams.
- Estimated gestation at birth less than 28 weeks or greater than 37 6/7 weeks.
- Active air leak syndrome.
- Subjects will not be eligible if they are not considered viable.
- Infants with abnormalities of the upper and lower airways
- Infants with significant abdominal or respiratory malformations .
Trial locations and contacts
1 site in 1 country.
United States1 site
Pennsylvania Hospital
Philadelphia, Pennsylvania, 19107
About this study
Official title: Pulmonary Mechanics in Preterm Infants Treated With Heated Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure.
This study is designed to evaluate the effect of heated humidified high flow nasal cannula (HHHFNC) as compared to noninvasive nasal continuous positive airway pressure (NCPAP) on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support.
Read the detailed description
Respiratory distress and the need for respiratory support continues to be a common problem for preterm infants. Presence of the breathing tube and duration of respirator provided breaths have been shown to be associated with increased risk for secondary lung injury and subsequent development of chronic lung disease of prematurity. Early application of noninvasive nasal continuous positive airway pressure (NCPAP) has been shown to be an effective, non-invasive, mode of respiratory support in preterm infants and to be associated with a lower incidence of chronic lung disease. A recently published large randomized multicenter study concluded that, among infants born at 28 weeks and longer gestation, heated humidified high flow nasal cannula (HHHFNC) had similar clinical efficacy and safety as compared to NCPAP. Both NCPAP and HHHFNC are currently used to assist infants with breathing problems.
This study is designed to evaluate the effect of HHHFNC as compared to NCPAP on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support. In this study, infants will remain on the assigned treatment of either NCPAP or HHHFNC until they require more support as provided by a respirator or until a treatment cross-over from NCPAP to HHHFNC, or the reverse, as decided by their attending physician. The infant's respiratory support will be managed according to his/her attending doctor as per accepted standards of care. A pulmonary function test will be performed twice weekly on each enrolled infant while receiving either NCPAP or HHHFNC support, followed-up by once weekly lung function measurements post respiratory support while infants are breathing only room air until discharge.
- Conditions
- Respiratory Distress, Lung Injury
- Being tested
- Heated Humidified High Flow Nasal Cannula, Nasal Continuous Positive Airway Pressure
- Keywords
- respiratory distress, Heated Humidified High Flow Nasal Cannula (HHHFNC), HHHFNC, noninvasive nasal continuous positive airway pressure (NCPAP), NCPAP
- Medical subject headings
- Dyspnea, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heated Humidified High Flow Nasal CannulaDevice
Biweekly measurement of lung mechanics (dynamic compliance, airway resistance, work of breathing) and chest wall asynchrony measures while on HHHFNC and weekly when weaned off until 40 weeks post conceptional age or discharge. Recording of the level and the type of respiratory support and all cross over respiratory support devices. Recording of all growth parameters, neonatal morbidities and therapies.
Nasal Continuous Positive Airway PressureDevice
Biweekly measurement of lung mechanics (dynamic compliance, airway resistance, work of breathing) and chest wall asynchrony measures while on NCPAP and weekly when weaned off until 40 weeks post conceptional age or discharge. Recording of the level and the type of respiratory support and all cross over respiratory support devices. Recording of all growth parameters, neonatal morbidities and therapies.
| Study group | Role | What they receive |
|---|---|---|
| HHHFNC | Other | Treatment of respiratory distress by Heated Humidified High Flow Nasal Cannula (HHHFNC).
Escalation of the ventilatory support per protocol and the attending physician. Receives: Device: Heated Humidified High Flow Nasal Cannula |
| NCPAP | Other | Treatment of respiratory distress by nasal continuous positive airway pressure (NCPAP).
Escalation of the ventilatory support per protocol and the attending physician. Receives: Device: Nasal Continuous Positive Airway Pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary mechanics and chest wall asynchrony measures.
Pulmonary mechanics measures consisting of dynamic lung compliance, airway resistance, and work of breathing and chest wall asynchrony measures consisting of thoracoabdominal asynchrony, labored breathing index and rib cage to abdominal phase relation during the total breath are measured in preterm infants treated with HHHFNC and compared to the same measurements in preterm infants treated with NCPAP.
Measured: 2 years
Secondary outcomes (3)
Duration of respiratory support or oxygen use up to the time of discharge from the NICU.
The total number of days while infants are on any type of respiratory support or oxygen use prior to discharge in preterm infants treated with HHHFNC compared to NCPAP during their hospital stay.
Measured: 2 years
The incidence of potential adverse outcomes associated with HHHFNC or NCPAP.
The number and percentage of infants in each group with adverse effects such as facial and upper airways injury associated with the use of HHHFNC or NCPAP.
Measured: 2 years
Time needed to establish full enteral feeds
The total number of days needed to establish full enteral feeds in preterm infants treated with HHHFNC as compared to preterm infants treated with NCPAP.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startMar 2014
- Primary completionMar 2014
- Study completionMar 2014
Why it stopped: Application for regulatory approval withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DistressStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soraya Abbasi, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939067
- Sponsor's protocol ID
- 12-009882
- Status last verified
- Sep 2015
- First submitted
- 30 Aug 2013
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulmonary Mechanics in Preterm Infants Treated With Heated Humidified High Flow Nasal Cannula as Compared to Nasal Continuous Positive Airway Pressure.
- ClinicalTrials.gov ID
- NCT01939067
- Acronym / sponsor ID
- 12-009882
- Conditions
- Respiratory Distress, Lung Injury
- Keywords
- respiratory distress, Heated Humidified High Flow Nasal Cannula (HHHFNC), HHHFNC, noninvasive nasal continuous positive airway pressure (NCPAP), NCPAP
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Application for regulatory approval withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 11 Sep 2013 (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 is designed to evaluate the effect of heated humidified high flow nasal cannula (HHHFNC) as compared to noninvasive nasal continuous positive airway pressure (NCPAP) on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support.
Detailed description
Respiratory distress and the need for respiratory support continues to be a common problem for preterm infants. Presence of the breathing tube and duration of respirator provided breaths have been shown to be associated with increased risk for secondary lung injury and subsequent development of chronic lung disease of prematurity. Early application of noninvasive nasal continuous positive airway pressure (NCPAP) has been shown to be an effective, non-invasive, mode of respiratory support in preterm infants and to be associated with a lower incidence of chronic lung disease. A recently published large randomized multicenter study concluded that, among infants born at 28 weeks and longer gestation, heated humidified high flow nasal cannula (HHHFNC) had similar clinical efficacy and safety as compared to NCPAP. Both NCPAP and HHHFNC are currently used to assist infants with breathing problems.
This study is designed to evaluate the effect of HHHFNC as compared to NCPAP on lung function as a measure of lung injury in preterm infants born at 28 to 37 weeks gestation requiring continuing respiratory support. In this study, infants will remain on the assigned treatment of either NCPAP or HHHFNC until they require more support as provided by a respirator or until a treatment cross-over from NCPAP to HHHFNC, or the reverse, as decided by their attending physician. The infant's respiratory support will be managed according to his/her attending doctor as per accepted standards of care. A pulmonary function test will be performed twice weekly on each enrolled infant while receiving either NCPAP or HHHFNC support, followed-up by once weekly lung function measurements post respiratory support while infants are breathing only room air until discharge.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HHHFNC | Other | Device: Heated Humidified High Flow Nasal CannulaTreatment of respiratory distress by Heated Humidified High Flow Nasal Cannula (HHHFNC). Escalation of the ventilatory support per protocol and the attending physician. |
| NCPAP | Other | Device: Nasal Continuous Positive Airway PressureTreatment of respiratory distress by nasal continuous positive airway pressure (NCPAP). Escalation of the ventilatory support per protocol and the attending physician. |
Who may qualify
- Ages
- 2 to 72 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Birth weight greater than or equal to 1000 grams.
- Gestational age at birth between 28 weeks and 37 weeks (28 0/7 to 37 6/7 weeks inclusive).
- Candidate for non-invasive respiratory support as a result of:
- Subjects must have a guardian or acceptable surrogate capable of giving consent on his/her behalf.
Key exclusion criteria (6 listed)
- Birth weight less than 1000 grams.
- Estimated gestation at birth less than 28 weeks or greater than 37 6/7 weeks.
- Active air leak syndrome.
- Subjects will not be eligible if they are not considered viable.
- Infants with abnormalities of the upper and lower airways
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 |
|---|---|---|
| Heated Humidified High Flow Nasal CannulaBiweekly measurement of lung mechanics (dynamic compliance, airway resistance, work of breathing) and chest wall asynchrony measures while on HHHFNC and weekly when weaned off until 40 weeks post conceptional age or discharge. Recording of the level and the type of respiratory support and all cross over respiratory support devices. Recording of all growth parameters, neonatal morbidities and therapies. | Device | HHHFNC |
| Nasal Continuous Positive Airway PressureBiweekly measurement of lung mechanics (dynamic compliance, airway resistance, work of breathing) and chest wall asynchrony measures while on NCPAP and weekly when weaned off until 40 weeks post conceptional age or discharge. Recording of the level and the type of respiratory support and all cross over respiratory support devices. Recording of all growth parameters, neonatal morbidities and therapies. | Device | NCPAP |
Primary outcome
Pulmonary mechanics and chest wall asynchrony measures.
Time frame: 2 years
Pulmonary mechanics measures consisting of dynamic lung compliance, airway resistance, and work of breathing and chest wall asynchrony measures consisting of thoracoabdominal asynchrony, labored breathing index and rib cage to abdominal phase relation during the total breath are measured in preterm infants treated with HHHFNC and compared to the same measurements in preterm infants treated with NCPAP.
3 secondary outcomes
Duration of respiratory support or oxygen use up to the time of discharge from the NICU.
Time frame: 2 years
The incidence of potential adverse outcomes associated with HHHFNC or NCPAP.
Time frame: 2 years
Time needed to establish full enteral feeds
Time frame: 2 years
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 15 Sep 2015.
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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.
Soraya Abbasi, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Heated Humidified High Flow Nasal Cannula and Nasal Continuous Positive Airway Pressure in people with Respiratory Distress and Lung Injury, run by Children's Hospital of Philadelphia 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 6 inclusion and 6 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 15 Sep 2015. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Pulmonary mechanics and chest wall asynchrony measures. (time frame: 2 years). 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 15 Sep 2015.