PrematurityNCT06038565
Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates
A study testing RAM cannula ventilator CPAP and Occlusive interface bubble CPAP in people with Prematurity and Respiratory Distress Syndrome, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The goal of this clinical trial is to compare late preterm newborn lung physiology when supported with different continuous positive airway pressure (CPAP) devices. The main questions it aims to answer are: Which CPAP modality provides better breathing support in newborns with respiratory distress syndrome who are… Read more about this study
- Who is it for?
- Ages 12 to 36 hours
- Conditions the study is for
- Prematurity, Respiratory Distress Syndrome
- What is being tested?
- RAM cannula ventilator CPAP and Occlusive interface bubble CPAP
- 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
- 18 Oct 2023to 11 Apr 2024
- 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 12 to 36 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- medically stable neonates born >32 0/7 weeks and < 37 0/7 weeks gestational age, with birth weights > 1500 grams, are chronologically 12-36 hours old, and are receiving RAM cannula ventilator CPAP with positive end expiratory pressure (PEEP) between 5-6 cm water (H2O) and Fraction of inspired oxygen (FiO2) < 0.3 for the suspected diagnosis of respiratory distress syndrome
Who cannot join
- neonates with congenital anomalies that potentially will affect respiratory physiology, for example hypoplastic lungs or gastroschisis.
- neonates with contraindications for wearing an occlusive interface, for example epidermolysis bullosa which may have risk of worsening skin integrity at the pressure points of the occlusive interface, or a known small air leak that may potentially develop into a large pneumothorax.
- neonates with contraindications for placement of esophageal balloon manometry, for example hypoglycemia managed with extended feeding times greater than 30 minutes.
- neonates with contraindications for electrical impedance tomography, for example inability to ensure contact of the electrodes on the belt with the skin on the circumference of the chest due to presence of a chest tube dressing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Comparing Regional Ventilation in Neonates With Different Delivery Systems of Continuous Positive Airway Pressure
The goal of this clinical trial is to compare late preterm newborn lung physiology when supported with different continuous positive airway pressure (CPAP) devices.
The main questions it aims to answer are:
Read more
- Which CPAP modality provides better breathing support in newborns with respiratory distress syndrome who are greater than 32 weeks gestational age?
- Does the lung physiology data predict the CPAP modality that will result in a shorter CPAP treatment duration?
Participants will wear a belt of electrodes on their chest (electrical impedance tomography) and have an esophageal balloon manometry measure lung physiology data for 2.5 hours while switching CPAP devices. Participants will then be randomly assigned to a CPAP device to support their breathing until they recover from respiratory distress syndrome.
Read the detailed description
Across centers, there is a variation in standard of care for the preferred device and interface to deliver continuous positive airway pressure (CPAP) to support neonatal functional residual capacity. CPAP, a type of noninvasive respiratory support, is commonly delivered to neonates by mechanical ventilators or underwater bubble devices (bubble CPAP). Variation also exists with the tubing used to deliver CPAP. One commonly used nasal interface is the RAM cannula (Neotech, Valencia, CA), made of a soft material with thin tubing walls and is designed to provide 60-80% occlusion of the nares. This contrasts with the occlusive interface intended to provide complete seal.
To provide evidence for standardization of CPAP delivery, clinical trials are needed to assess which modality of CPAP delivery is optimal for neonates with respiratory distress syndrome who are > 32 weeks and <37 weeks gestational age, an understudied population. The investigators propose to use electrical impedance tomography (EIT) paired with esophageal balloon manometry to assess neonatal lung physiology when supported with different modalities of CPAP. Furthermore, participants will be randomly assigned to A) physiology based CPAP vs B) one size fits all approach. The subjects will remain on the assigned modality of CPAP for the remainder of their respiratory distress syndrome treatment, and researchers will track which modality of CPAP results in a shorter CPAP treatment period and if this is expected based on the lung physiology data collected.
- Conditions
- Prematurity, Respiratory Distress Syndrome
- Being tested
- RAM cannula ventilator CPAP, Occlusive interface bubble CPAP
- Keywords
- continuous positive airway pressure
- Medical subject headings
- Premature Birth, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAM cannula ventilator CPAPDevice
RAM cannula ventilator CPAP
Occlusive interface bubble CPAPDevice
Occlusive interface bubble CPAP
| Study group | Role | What they receive |
|---|---|---|
| Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-1" | Experimental | After comparing change of impedance as measured by electrical impedance tomography while supported on RAM cannula ventilator CPAP versus occlusive interface bubble CPAP, the participants in this arm are placed on the CPAP that had a greater change of impedance (or less pressure rate product as measured by the esophageal balloon manometry if the change of impedance between the two CPAP modalities are clinically similar).
In this Arm A-1, these subjects had higher change in impedance while supported on RAM cannula ventilator CPAP Receives: Device: RAM cannula ventilator CPAP |
| Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-2" | Experimental | After comparing change of impedance as measured by electrical impedance tomography while supported on RAM cannula ventilator CPAP versus occlusive interface bubble CPAP, the participants in this arm are placed on the CPAP that had a greater change of impedance (or less pressure rate product as measured by the esophageal balloon manometry if the change of impedance between the two CPAP modalities are clinically similar).
In this Arm A-2, these subjects had higher change in impedance while supported on occlusive mask bubble CPAP Receives: Device: Occlusive interface bubble CPAP |
| Randomization to standard of care - a 'one size fits all' approach. "Arm B-1" | Active comparator | Currently, the approach to which CPAP modality is chosen for these newborns is defaulted to the preferred CPAP of the Neonatal Intensive Care Unit (NICU) where the newborn is hospitalized.
In this Arm B-1, these subjects are randomized 1:1 to RAM cannula ventilator CPAP Receives: Device: RAM cannula ventilator CPAP |
| Randomization to standard of care - a 'one size fits all' approach. "Arm B-2" | Active comparator | Currently, the approach to which CPAP modality is chosen for these newborns is defaulted to the preferred CPAP of the NICU where the newborn is hospitalized.
In this Arm B-2, these subjects are randomized 1:1 to occlusive mask bubble CPAP Receives: Device: Occlusive interface bubble CPAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in electrical impedance
change in average electrical impedance with each CPAP delivery modality
Measured: 2.5 hours during the lung physiology assessment
duration of CPAP treatment
compare groups Arm A-1, A-2 vs Arm B-1, B2; Compare groups Arm A-1, B-1 vs Arm A-2, B-2
Measured: through study completion, an average of 2 weeks after the lung physiology assessment
Secondary outcomes (14)
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in end expiratory lung impedance
change in end expiratory lung impedance (arbitrary units)
Measured: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) vascular pulsatility
vascular pulsatility (arbitrary units)
Measured: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) tidal volume
tidal volume (in milliliters) per weight (in kilograms)
Measured: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in minute ventilation
change in minute ventilation (mL/minute)
Measured: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in dynamic compliance
change in dynamic compliance (mL/cmH2O)
Measured: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Respiratory rate
Respiratory rate (breaths per minute)
Measured: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Oxygen saturation
Oxygen saturation (percentage)
Measured: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Abdominal circumference
Abdominal circumference (cm)
Measured: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) esophageal pressure change
esophageal pressure change (mm Hg)
Measured: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) end expiratory pressure
end expiratory pressure via esophageal balloon manometry (mm Hg)
Measured: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) pressure rate product
pressure rate product (cm H2O / min)
Measured: 2.5 hours during the lung physiology assessment
clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) Frequency of deviation
frequency of deviation from assigned CPAP treatment (percentage)
Measured: through study completion, an average of 2 weeks after the lung physiology assessment
clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) frequency of exogenous surfactant administration
frequency of exogenous surfactant administration (percentage)
Measured: through study completion, an average of 2 weeks after the lung physiology assessment
clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial)
respiratory support settings if deviated from assigned CPAP treatment (percentage)
Measured: through study completion, an average of 2 weeks after the lung physiology assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start18 Oct 2023
- Primary completion11 Apr 2024
- Study completion11 Apr 2024
Why it stopped: Unable to enroll participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PrematurityStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Lung physiology measurements with electrical impedance tomography and esophageal manometry will be collected while the participant is supported with RAM cannula ventilator CPAP followed by occlusive interface ventilator CPAP followed by occlusive interface bubble CPAP. A 1:1 block randomization of either A) physiology-based CPAP or B) one size fits all CPAP of either RAM cannula ventilator CPAP or occlusive interface bubble CPAP will be assigned to the participant. Arm B is further randomized 1:1 to either RAM cannula ventilator CPAP or occlusive interface bubble CPAP. The duration of CPAP treatment will be compared between the two arms (precision medicine approach vs standard of care) as well as compare each device and whether the physiology data would have predicted the CPAP device would have resulted in a shorter treatment period.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jessica E Shui, MD, Massachusetts General Hospital
- Investigators
- Jessica E Shui, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038565
- Sponsor's protocol ID
- 2023P001796
- Status last verified
- Jul 2024
- First submitted
- 29 Aug 2023
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Prakash R, De Paoli AG, Davis PG, Oddie SJ, McGuire W. Bubble devices versus other pressure sources for nasal continuous positive airway pressure in preterm infants. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD015130. doi: 10.1002/14651858.CD015130.
PubMed 37009665Prakash R, De Paoli AG, Oddie SJ, Davis PG, McGuire W. Masks versus prongs as interfaces for nasal continuous positive airway pressure in preterm infants. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD015129. doi: 10.1002/14651858.CD015129.
PubMed 36374241Green EA, Dawson JA, Davis PG, De Paoli AG, Roberts CT. Assessment of resistance of nasal continuous positive airway pressure interfaces. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F535-F539. doi: 10.1136/archdischild-2018-315838. Epub 2018 Dec 19.
PubMed 30567774Courtney SE, Pyon KH, Saslow JG, Arnold GK, Pandit PB, Habib RH. Lung recruitment and breathing pattern during variable versus continuous flow nasal continuous positive airway pressure in premature infants: an evaluation of three devices. Pediatrics. 2001 Feb;107(2):304-8. doi: 10.1542/peds.107.2.304.
PubMed 11158463Nascimento MS, do Prado C, Costa ELV, Alcala GC, Correa LC, Rossi FS, Amato MBP, Rebello CM. Effect of flow rate on the end-expiratory lung volume in infants with bronchiolitis using high-flow nasal cannula evaluated through electrical impedance tomography. Pediatr Pulmonol. 2022 Nov;57(11):2681-2687. doi: 10.1002/ppul.26082. Epub 2022 Aug 17.
PubMed 35931651Seddon PC, Davis GM. Validity of esophageal pressure measurements with positive end-expiratory pressure in preterm infants. Pediatr Pulmonol. 2003 Sep;36(3):216-22. doi: 10.1002/ppul.10284.
PubMed 12910583Bhatia R, Davis PG, Tingay DG. Regional Volume Characteristics of the Preterm Infant Receiving First Intention Continuous Positive Airway Pressure. J Pediatr. 2017 Aug;187:80-88.e2. doi: 10.1016/j.jpeds.2017.04.046. Epub 2017 May 22.
PubMed 28545875
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Regional Ventilation in Neonates With Different Delivery Systems of Continuous Positive Airway Pressure
- ClinicalTrials.gov ID
- NCT06038565
- Acronym / sponsor ID
- 2023P001796
- Conditions
- Prematurity, Respiratory Distress Syndrome
- Keywords
- continuous positive airway pressure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to enroll participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 18 Oct 2023 (actual)
- Primary completion
- 11 Apr 2024 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 15 Sep 2023 (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.
The goal of this clinical trial is to compare late preterm newborn lung physiology when supported with different continuous positive airway pressure (CPAP) devices.
The main questions it aims to answer are:
- Which CPAP modality provides better breathing support in newborns with respiratory distress syndrome who are greater than 32 weeks gestational age?
- Does the lung physiology data predict the CPAP modality that will result in a shorter CPAP treatment duration?
Participants will wear a belt of electrodes on their chest (electrical impedance tomography) and have an esophageal balloon manometry measure lung physiology data for 2.5 hours while switching CPAP devices. Participants will then be randomly assigned to a CPAP device to support their breathing until they recover from respiratory distress syndrome.
Detailed description
Across centers, there is a variation in standard of care for the preferred device and interface to deliver continuous positive airway pressure (CPAP) to support neonatal functional residual capacity. CPAP, a type of noninvasive respiratory support, is commonly delivered to neonates by mechanical ventilators or underwater bubble devices (bubble CPAP). Variation also exists with the tubing used to deliver CPAP. One commonly used nasal interface is the RAM cannula (Neotech, Valencia, CA), made of a soft material with thin tubing walls and is designed to provide 60-80% occlusion of the nares. This contrasts with the occlusive interface intended to provide complete seal.
To provide evidence for standardization of CPAP delivery, clinical trials are needed to assess which modality of CPAP delivery is optimal for neonates with respiratory distress syndrome who are > 32 weeks and <37 weeks gestational age, an understudied population. The investigators propose to use electrical impedance tomography (EIT) paired with esophageal balloon manometry to assess neonatal lung physiology when supported with different modalities of CPAP. Furthermore, participants will be randomly assigned to A) physiology based CPAP vs B) one size fits all approach. The subjects will remain on the assigned modality of CPAP for the remainder of their respiratory distress syndrome treatment, and researchers will track which modality of CPAP results in a shorter CPAP treatment period and if this is expected based on the lung physiology data collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
- Model description
- Lung physiology measurements with electrical impedance tomography and esophageal manometry will be collected while the participant is supported with RAM cannula ventilator CPAP followed by occlusive interface ventilator CPAP followed by occlusive interface bubble CPAP. A 1:1 block randomization of either A) physiology-based CPAP or B) one size fits all CPAP of either RAM cannula ventilator CPAP or occlusive interface bubble CPAP will be assigned to the participant. Arm B is further randomized 1:1 to either RAM cannula ventilator CPAP or occlusive interface bubble CPAP. The duration of CPAP treatment will be compared between the two arms (precision medicine approach vs standard of care) as well as compare each device and whether the physiology data would have predicted the CPAP device would have resulted in a shorter treatment period.
| Arm | Type | Receives |
|---|---|---|
| Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-1" | Experimental | Device: RAM cannula ventilator CPAPAfter comparing change of impedance as measured by electrical impedance tomography while supported on RAM cannula ventilator CPAP versus occlusive interface bubble CPAP, the participants in this arm are placed on the CPAP that had a greater change of impedance (or less pressure rate product as measured by the esophageal balloon manometry if the change of impedance between the two CPAP modalities are clinically similar). In this Arm A-1, these subjects had higher change in impedance while supported on RAM cannula ventilator CPAP |
| Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-2" | Experimental | Device: Occlusive interface bubble CPAPAfter comparing change of impedance as measured by electrical impedance tomography while supported on RAM cannula ventilator CPAP versus occlusive interface bubble CPAP, the participants in this arm are placed on the CPAP that had a greater change of impedance (or less pressure rate product as measured by the esophageal balloon manometry if the change of impedance between the two CPAP modalities are clinically similar). In this Arm A-2, these subjects had higher change in impedance while supported on occlusive mask bubble CPAP |
| Randomization to standard of care - a 'one size fits all' approach. "Arm B-1" | Active comparator | Device: RAM cannula ventilator CPAPCurrently, the approach to which CPAP modality is chosen for these newborns is defaulted to the preferred CPAP of the Neonatal Intensive Care Unit (NICU) where the newborn is hospitalized. In this Arm B-1, these subjects are randomized 1:1 to RAM cannula ventilator CPAP |
| Randomization to standard of care - a 'one size fits all' approach. "Arm B-2" | Active comparator | Device: Occlusive interface bubble CPAPCurrently, the approach to which CPAP modality is chosen for these newborns is defaulted to the preferred CPAP of the NICU where the newborn is hospitalized. In this Arm B-2, these subjects are randomized 1:1 to occlusive mask bubble CPAP |
Who may qualify
- Ages
- 12 to 36 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- medically stable neonates born >32 0/7 weeks and < 37 0/7 weeks gestational age, with birth weights > 1500 grams, are chronologically 12-36 hours old, and are receiving RAM cannula ventilator CPAP with positive end expiratory pressure (PEEP) between 5-6 cm water (H2O) and Fraction of inspired oxygen (FiO2) < 0.3 for the suspected diagnosis of respiratory distress syndrome
Key exclusion criteria (4 listed)
- neonates with congenital anomalies that potentially will affect respiratory physiology, for example hypoplastic lungs or gastroschisis.
- neonates with contraindications for wearing an occlusive interface, for example epidermolysis bullosa which may have risk of worsening skin integrity at the pressure points of the occlusive interface, or a known small air leak that may potentially develop into a large pneumothorax.
- neonates with contraindications for placement of esophageal balloon manometry, for example hypoglycemia managed with extended feeding times greater than 30 minutes.
- neonates with contraindications for electrical impedance tomography, for example inability to ensure contact of the electrodes on the belt with the skin on the circumference of the chest due to presence of a chest tube dressing.
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 ventilator CPAPRAM cannula ventilator CPAP | Device | Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-1", Randomization to standard of care - a 'one size fits all' approach. "Arm B-1" |
| Occlusive interface bubble CPAPOcclusive interface bubble CPAP | Device | Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-2", Randomization to standard of care - a 'one size fits all' approach. "Arm B-2" |
Primary outcome
change in electrical impedance
Time frame: 2.5 hours during the lung physiology assessment
change in average electrical impedance with each CPAP delivery modality
duration of CPAP treatment
Time frame: through study completion, an average of 2 weeks after the lung physiology assessment
compare groups Arm A-1, A-2 vs Arm B-1, B2; Compare groups Arm A-1, B-1 vs Arm A-2, B-2
14 secondary outcomes
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in end expiratory lung impedance
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) vascular pulsatility
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) tidal volume
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in minute ventilation
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in dynamic compliance
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Respiratory rate
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Oxygen saturation
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Abdominal circumference
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) esophageal pressure change
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) end expiratory pressure
Time frame: 2.5 hours during the lung physiology assessment
lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) pressure rate product
Time frame: 2.5 hours during the lung physiology assessment
clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) Frequency of deviation
Time frame: through study completion, an average of 2 weeks after the lung physiology assessment
clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) frequency of exogenous surfactant administration
Time frame: through study completion, an average of 2 weeks after the lung physiology assessment
clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial)
Time frame: through study completion, an average of 2 weeks after the lung physiology assessment
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 8 Jul 2024.
- Background: PubMed 37009665Prakash R, De Paoli AG, Davis PG, Oddie SJ, McGuire W. Bubble devices versus other pressure sources for nasal continuous positive airway pressure in preterm infants. Cochrane Database Syst Rev. 2023 Mar 31;3(3):CD015130. doi: 10.1002/14651858.CD015130.
- Background: PubMed 36374241Prakash R, De Paoli AG, Oddie SJ, Davis PG, McGuire W. Masks versus prongs as interfaces for nasal continuous positive airway pressure in preterm infants. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD015129. doi: 10.1002/14651858.CD015129.
- Background: PubMed 30567774Green EA, Dawson JA, Davis PG, De Paoli AG, Roberts CT. Assessment of resistance of nasal continuous positive airway pressure interfaces. Arch Dis Child Fetal Neonatal Ed. 2019 Sep;104(5):F535-F539. doi: 10.1136/archdischild-2018-315838. Epub 2018 Dec 19.
- Background: PubMed 11158463Courtney SE, Pyon KH, Saslow JG, Arnold GK, Pandit PB, Habib RH. Lung recruitment and breathing pattern during variable versus continuous flow nasal continuous positive airway pressure in premature infants: an evaluation of three devices. Pediatrics. 2001 Feb;107(2):304-8. doi: 10.1542/peds.107.2.304.
- Background: PubMed 35931651Nascimento MS, do Prado C, Costa ELV, Alcala GC, Correa LC, Rossi FS, Amato MBP, Rebello CM. Effect of flow rate on the end-expiratory lung volume in infants with bronchiolitis using high-flow nasal cannula evaluated through electrical impedance tomography. Pediatr Pulmonol. 2022 Nov;57(11):2681-2687. doi: 10.1002/ppul.26082. Epub 2022 Aug 17.
- Background: PubMed 12910583Seddon PC, Davis GM. Validity of esophageal pressure measurements with positive end-expiratory pressure in preterm infants. Pediatr Pulmonol. 2003 Sep;36(3):216-22. doi: 10.1002/ppul.10284.
- Background: PubMed 28545875Bhatia R, Davis PG, Tingay DG. Regional Volume Characteristics of the Preterm Infant Receiving First Intention Continuous Positive Airway Pressure. J Pediatr. 2017 Aug;187:80-88.e2. doi: 10.1016/j.jpeds.2017.04.046. Epub 2017 May 22.
- 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.
Jessica E Shui, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RAM cannula ventilator CPAP and Occlusive interface bubble CPAP in people with Prematurity and Respiratory Distress Syndrome, run by Massachusetts General Hospital 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 1 inclusion and 4 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 8 Jul 2024. 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 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?
change in electrical impedance (time frame: 2.5 hours during the lung physiology assessment). 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?
On the ClinicalTrials.gov record for NCT06038565, which also lists 7 linked publications.
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 8 Jul 2024.