Respiratory Distress Syndrome in Premature InfantNCT04326270
Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs
A study testing Nasal interface in people with Respiratory Distress Syndrome in Premature Infant, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
Trial summary
Crossover bedside clinical study to examine relative tidal volume delivery during nasal intermittent positive pressure ventilation (NIPPV) and directly compare the RAM® infant cannula to a nasal continuous positive airway pressure (nCPAP) delivery system in vivo. Read more about this study
- Who is it for?
- Ages Up to 28 days
- Conditions the study is for
- Respiratory Distress Syndrome in Premature Infant
- What is being tested?
- Nasal interface
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Mar 2019to 30 Jun 2020
- 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
- Chronologic age less than 28 days
- Gestational age at birth between 24 weeks 0 days to 34 weeks 6 days
- Currently receiving NIPPV, NIV NAVA, or nCPAP
Who cannot join
- Oxygen requirement greater than 40%
- Peak inspiratory pressure greater than 20 cm H2O
- Major congenital anomalies of the heart or lungs
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Arkansas Children's Hospital
Little Rock, Arkansas, 72202
Ashley Lynch, M.D., 501-412-0988, allynch@uams.edu
Ashley L Lynch, M.D.
About this study
Crossover bedside clinical study to examine relative tidal volume delivery during nasal intermittent positive pressure ventilation (NIPPV) and directly compare the RAM® infant cannula to a nasal continuous positive airway pressure (nCPAP) delivery system in vivo. The study population will consist of preterm neonates with mild respiratory insufficiency who are receiving NIPPV, non-invasive neurally adjusted ventilatory assist (NIV NAVA), or nCPAP.
Read the detailed description
Bedside crossover study of neonates with mild respiratory distress receiving NIPPV. Infants serve as their own controls and are randomized to initial interface of either RAM® infant cannula or Miniflow® nCPAP prongs. Infants are instrumented with the following monitoring equipment: Edi orogastric tube to measure electrical activity of the diaphragm, transcutaneous monitor to measure transcutaneous CO2 and O2, pulse oximeter to measure heart rate and oxygen saturation, and respiratory inductance plethysmography (RIP) bands around the chest and abdomen to measure breathing movements and relative Vt (arbitrary units, a.u.). Data are continuously and simultaneously acquired using a data acquisition system. After 10 minutes of stabilization, infants receive 5 minutes of NIPPV on each of a sequence of four commonly used pressure settings (expressed as peak inspiratory pressure / positive end expiratory pressure): 16/5, 16/8, 20/5, 20/8. This sequence is not randomized and is constant between interfaces. Subjects are then placed on the alternate interface, and the sequence is repeated. Events ("breaths") are separated into 3 types: patient effort synchronized with NIPPV breaths (type I), NIPPV breaths without patient effort (type II), and patient effort without NIPPV breaths (type III).
- Being tested
- Nasal interface
- Keywords
- nasal intermittent positive pressure ventilation, non-invasive ventilation, nasal continuous positive airway pressure prongs, infant nasal cannula, tidal volume
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nasal interfaceDevice
Also called Neotech RAM infant cannula, Miniflow Nasal CPAP Prongs
Randomized to initial interface of nCPAP prongs or infant cannula
| Study group | Role | What they receive |
|---|---|---|
| nCPAP prongs | Active comparator | Not described Receives: Device: Nasal interface |
| Infant cannula | Active comparator | Not described Receives: Device: Nasal interface |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative tidal volume delivery, breath type I
Relative tidal volume measured in arbitrary units (AU) via RIP bands during synchronized breaths
Measured: 1 hour
Relative tidal volume delivery, breath type II
Relative tidal volume measured in arbitrary units (AU) via RIP bands during ventilator-driven breaths
Measured: 1 hour
Relative tidal volume delivery, breath type III
Relative tidal volume measured in arbitrary units (AU) via RIP bands during patient-driven breaths
Measured: 1 hour
Secondary outcomes (6)
Ventilator pressure delivery
Measured: 1 hour
Ventilator flow delivery
Measured: 1 hour
Heart rate
Measured: 1 hour
Oxygen saturation
Measured: 1 hour
Transcutaneous carbon dioxide tension
Measured: 1 hour
Transcutaneous oxygen tension
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start7 Mar 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ashley L. Lynch, Arkansas Children's Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04326270
- Sponsor's protocol ID
- GR037133
- Status last verified
- Mar 2020
- First submitted
- 26 Mar 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Lynch AL, Matlock DN, Akmyradov C, Weisner MD, Beck J, Sinderby C, Courtney SE. Tidal volume delivery during nasal intermittent positive pressure ventilation: infant cannula vs. nasal continuous positive airway pressure prongs. J Perinatol. 2024 Feb;44(2):244-249. doi: 10.1038/s41372-023-01846-7. Epub 2023 Dec 21.
PubMed 38129599
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Crossover Comparison of Tidal Volume Delivery During Nasal Intermittent Positive Pressure Ventilation in Preterm Infants: Infant Cannula vs. Nasal Continuous Positive Airway Pressure Prongs
- ClinicalTrials.gov ID
- NCT04326270
- Acronym / sponsor ID
- GR037133
- Keywords
- nasal intermittent positive pressure ventilation, non-invasive ventilation, nasal continuous positive airway pressure prongs, infant nasal cannula, tidal volume
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- Study start
- 7 Mar 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 30 Mar 2020 (actual)
- 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.
Crossover bedside clinical study to examine relative tidal volume delivery during nasal intermittent positive pressure ventilation (NIPPV) and directly compare the RAM® infant cannula to a nasal continuous positive airway pressure (nCPAP) delivery system in vivo. The study population will consist of preterm neonates with mild respiratory insufficiency who are receiving NIPPV, non-invasive neurally adjusted ventilatory assist (NIV NAVA), or nCPAP.
Detailed description
Bedside crossover study of neonates with mild respiratory distress receiving NIPPV. Infants serve as their own controls and are randomized to initial interface of either RAM® infant cannula or Miniflow® nCPAP prongs. Infants are instrumented with the following monitoring equipment: Edi orogastric tube to measure electrical activity of the diaphragm, transcutaneous monitor to measure transcutaneous CO2 and O2, pulse oximeter to measure heart rate and oxygen saturation, and respiratory inductance plethysmography (RIP) bands around the chest and abdomen to measure breathing movements and relative Vt (arbitrary units, a.u.). Data are continuously and simultaneously acquired using a data acquisition system. After 10 minutes of stabilization, infants receive 5 minutes of NIPPV on each of a sequence of four commonly used pressure settings (expressed as peak inspiratory pressure / positive end expiratory pressure): 16/5, 16/8, 20/5, 20/8. This sequence is not randomized and is constant between interfaces. Subjects are then placed on the alternate interface, and the sequence is repeated. Events ("breaths") are separated into 3 types: patient effort synchronized with NIPPV breaths (type I), NIPPV breaths without patient effort (type II), and patient effort without NIPPV breaths (type III).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nCPAP prongs | Active comparator | Device: Nasal interface |
| Infant cannula | Active comparator | Device: Nasal interface |
Who may qualify
- Ages
- Up to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Chronologic age less than 28 days
- Gestational age at birth between 24 weeks 0 days to 34 weeks 6 days
- Currently receiving NIPPV, NIV NAVA, or nCPAP
Key exclusion criteria (3 listed)
- Oxygen requirement greater than 40%
- Peak inspiratory pressure greater than 20 cm H2O
- Major congenital anomalies of the heart or lungs
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 interfaceAlso: Neotech RAM infant cannula, Miniflow Nasal CPAP ProngsRandomized to initial interface of nCPAP prongs or infant cannula | Device | Infant cannula, nCPAP prongs |
Primary outcome
Relative tidal volume delivery, breath type I
Time frame: 1 hour
Relative tidal volume measured in arbitrary units (AU) via RIP bands during synchronized breaths
Relative tidal volume delivery, breath type II
Time frame: 1 hour
Relative tidal volume measured in arbitrary units (AU) via RIP bands during ventilator-driven breaths
Relative tidal volume delivery, breath type III
Time frame: 1 hour
Relative tidal volume measured in arbitrary units (AU) via RIP bands during patient-driven breaths
6 secondary outcomes
Ventilator pressure delivery
Time frame: 1 hour
Ventilator flow delivery
Time frame: 1 hour
Heart rate
Time frame: 1 hour
Oxygen saturation
Time frame: 1 hour
Transcutaneous carbon dioxide tension
Time frame: 1 hour
Transcutaneous oxygen tension
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Derived from this study: PubMed 38129599Lynch AL, Matlock DN, Akmyradov C, Weisner MD, Beck J, Sinderby C, Courtney SE. Tidal volume delivery during nasal intermittent positive pressure ventilation: infant cannula vs. nasal continuous positive airway pressure prongs. J Perinatol. 2024 Feb;44(2):244-249. doi: 10.1038/s41372-023-01846-7. Epub 2023 Dec 21.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nasal interface in people with Respiratory Distress Syndrome in Premature Infant, run by Arkansas Children's Hospital Research Institute 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 3 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: status not confirmed, as of the sponsor's last update on 30 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ashley Lynch, M.D. (501-412-0988, allynch@uams.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relative tidal volume delivery, breath type I (time frame: 1 hour). The study lists 3 primary outcomes in all. 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 NCT04326270, 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 30 Mar 2020.