Respiratory Distress Syndrome in Premature InfantNCT03212508
Comparison of Two Nasal Interface for CPAP in Preterm
An observational study of Respiratory Distress Syndrome in Premature Infant, run by Dartmouth-Hitchcock Medical Center.
Trial summary
Continuous distending airway pressure (CPAP) has gained popularity as a means to provide non-invasive respiratory support in neonates to reduce ventilator induced lung injury (VILI). Read more about this study
- Who is it for?
- Ages 48 hours to 52 weeks
- Conditions the study is for
- Respiratory Distress Syndrome in Premature Infant
- What is being tested?
- RAM cannula and Hudson prongs
- Type of treatment
- Medical device
- How many people
- 12 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 22 Mar 2017
- Phase
- Observational
- 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 48 hours to 52 weeks
- All sexes
- No healthy volunteers
- Child
Study population: Any preterm with respiratory distress requiring CPAP
Who may be able to join
- Any preterm with respiratory distress requiring CPAP but not mechanical ventilation or NIPPV will be eligible for the study. We will recruit preterm infant more than 48 hours old and stable on bubble CPAP
Who cannot join
- Infants with major congenital anomalies, neuromuscular disorders, upper airway anomalies, critically sick infants
About this study
Official title: Comparison of Two Nasal Interface for Continuous Distending Airway Pressure in Preterm Infants: RAM Nasal Cannula and Hudson Prongs
Continuous distending airway pressure (CPAP) has gained popularity as a means to provide non-invasive respiratory support in neonates to reduce ventilator induced lung injury (VILI). However, maintaining CPAP in preterm infants has been challenging, often related to issues with nasal interface such as nasal septal injury, problems with keeping the prongs in the nose and leak around the prongs with are important factors in proving effective CPAP. RAM cannula was recently approved for providing supplemental oxygen and soon adapted by many centers to provide CPAP in preterm infants. Concerns have been raised that RAM cannula interface results in sub-optimal pressure delivery compared to standard nasal prongs.
Read the detailed description
Objective:
To compare efficacy of delivering continuous distending pressure in preterm neonates using RAM cannula versus the standard prongs (Hudson prongs) by measuring intra-oral pressure. It is hypothesize that CPAP delivered with RAM cannula is comparable to pressure delivered via standard nasal interface in routine clinical practice; and the desired CPAP level is often not achieved in presence of variable leak from mouth irrespective of type of nasal interface.
Aim 1: Compare the level of CPAP in oral cavity between RAM cannula and Hudson prong nasal interface in preterm Hypothesis: The intraoral pressure with CPAP will not be different with use of RAM cannula or Hudson prong nasal interface
Aim 2: Evaluate the effect of nasal interface (RAM cannula and Hudson prong) on respiratory variables Hypothesis: There will be no difference in respiratory variables with CPAP delivered by RAM cannula compared to Hudson prongs.
Method:
This was a single center prospective study. Inclusion criteria: Any preterm with respiratory distress requiring CPAP but not mechanical ventilation or NIPPV was eligible for the study. 12 preterm infant more than 48 hours old and stable on bubble CPAP were recruited for the study Exclusion criteria: Infants with major congenital anomalies, neuromuscular disorders, upper airway anomalies, critically sick infants
CPHS approval and parental consent was obtained prior to enrollment in the study.
Each infant was studied for ~1 hour during which the oral pressure was measured while receiving CPAP with RAM nasal cannula interface and then with Hudson prongs. Blinding of the intervention (nasal interface) was not feasible because of the visible differences in the two nasal interfaces.
Procedure: Intra-oral pressure measured via a differential pressure transducer while infant in receiving CPAP, and digitized data recorded with each nasal interface ( goal to record at least 20 sec of stable waveform on each nasal interface). Standard care provided during the study period and no changes made with CPAP level or flow.
The difference between set pressure and measured pressure with RAM cannula and Hudson prong was compared with standard paired student t-test with 95% confidence limits. Difference in other variables will be similarly compared with t-test. STAT 12 will be used for statistical analysis.
- Being tested
- RAM cannula and Hudson prongs
- Keywords
- Continuous positive airway pressure, preterm
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAM cannula and Hudson prongsDevice
Measuring intraoral pressure using two different nasal interface for applying nasal continuous positive airway pressure
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference between set pressure and measured pressure with RAM cannula and Hudson prong
Intraoral pressure measure using a differential pressure transducer with RAM cannula and then with Hudson prongs
Measured: one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start1 Aug 2016
- Primary completion22 Mar 2017
- Study completion22 Mar 2017
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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212508
- Sponsor's protocol ID
- STUDY00029410
- Status last verified
- Jul 2023
- First submitted
- 6 Jul 2017
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Singh N, McNally MJ, Darnall RA. Does the RAM Cannula Provide Continuous Positive Airway Pressure as Effectively as the Hudson Prongs in Preterm Neonates? Am J Perinatol. 2019 Jul;36(8):849-854. doi: 10.1055/s-0038-1675330. Epub 2018 Nov 5.
PubMed 30396227
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Nasal Interface for Continuous Distending Airway Pressure in Preterm Infants: RAM Nasal Cannula and Hudson Prongs
- ClinicalTrials.gov ID
- NCT03212508
- Acronym / sponsor ID
- STUDY00029410
- Keywords
- Continuous positive airway pressure, preterm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 22 Mar 2017 (actual)
- Study completion
- 22 Mar 2017 (actual)
- First posted
- 11 Jul 2017 (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.
Continuous distending airway pressure (CPAP) has gained popularity as a means to provide non-invasive respiratory support in neonates to reduce ventilator induced lung injury (VILI). However, maintaining CPAP in preterm infants has been challenging, often related to issues with nasal interface such as nasal septal injury, problems with keeping the prongs in the nose and leak around the prongs with are important factors in proving effective CPAP. RAM cannula was recently approved for providing supplemental oxygen and soon adapted by many centers to provide CPAP in preterm infants. Concerns have been raised that RAM cannula interface results in sub-optimal pressure delivery compared to standard nasal prongs.
Detailed description
Objective:
To compare efficacy of delivering continuous distending pressure in preterm neonates using RAM cannula versus the standard prongs (Hudson prongs) by measuring intra-oral pressure. It is hypothesize that CPAP delivered with RAM cannula is comparable to pressure delivered via standard nasal interface in routine clinical practice; and the desired CPAP level is often not achieved in presence of variable leak from mouth irrespective of type of nasal interface.
Aim 1: Compare the level of CPAP in oral cavity between RAM cannula and Hudson prong nasal interface in preterm Hypothesis: The intraoral pressure with CPAP will not be different with use of RAM cannula or Hudson prong nasal interface
Aim 2: Evaluate the effect of nasal interface (RAM cannula and Hudson prong) on respiratory variables Hypothesis: There will be no difference in respiratory variables with CPAP delivered by RAM cannula compared to Hudson prongs.
Method:
This was a single center prospective study. Inclusion criteria: Any preterm with respiratory distress requiring CPAP but not mechanical ventilation or NIPPV was eligible for the study. 12 preterm infant more than 48 hours old and stable on bubble CPAP were recruited for the study Exclusion criteria: Infants with major congenital anomalies, neuromuscular disorders, upper airway anomalies, critically sick infants
CPHS approval and parental consent was obtained prior to enrollment in the study.
Each infant was studied for ~1 hour during which the oral pressure was measured while receiving CPAP with RAM nasal cannula interface and then with Hudson prongs. Blinding of the intervention (nasal interface) was not feasible because of the visible differences in the two nasal interfaces.
Procedure: Intra-oral pressure measured via a differential pressure transducer while infant in receiving CPAP, and digitized data recorded with each nasal interface ( goal to record at least 20 sec of stable waveform on each nasal interface). Standard care provided during the study period and no changes made with CPAP level or flow.
The difference between set pressure and measured pressure with RAM cannula and Hudson prong was compared with standard paired student t-test with 95% confidence limits. Difference in other variables will be similarly compared with t-test. STAT 12 will be used for statistical analysis.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
Who may qualify
- Ages
- 48 hours to 52 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Any preterm with respiratory distress requiring CPAP
Key inclusion criteria (1 listed)
- Any preterm with respiratory distress requiring CPAP but not mechanical ventilation or NIPPV will be eligible for the study. We will recruit preterm infant more than 48 hours old and stable on bubble CPAP
Key exclusion criteria (1 listed)
- Infants with major congenital anomalies, neuromuscular disorders, upper airway anomalies, critically sick infants
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 |
|---|---|---|
| RAM cannula and Hudson prongsMeasuring intraoral pressure using two different nasal interface for applying nasal continuous positive airway pressure | Device | – |
Primary outcome
The difference between set pressure and measured pressure with RAM cannula and Hudson prong
Time frame: one hour
Intraoral pressure measure using a differential pressure transducer with RAM cannula and then with Hudson prongs
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 13 Jul 2023.
- Derived from this study: PubMed 30396227Singh N, McNally MJ, Darnall RA. Does the RAM Cannula Provide Continuous Positive Airway Pressure as Effectively as the Hudson Prongs in Preterm Neonates? Am J Perinatol. 2019 Jul;36(8):849-854. doi: 10.1055/s-0038-1675330. Epub 2018 Nov 5.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Respiratory Distress Syndrome in Premature Infant, run by Dartmouth-Hitchcock Medical Center.
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 1 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 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The difference between set pressure and measured pressure with RAM cannula and Hudson prong (time frame: one hour). 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 NCT03212508, 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 13 Jul 2023.