Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates
NCT ID: NCT06038565
Last Updated: 2024-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2023-10-18
2024-04-11
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-1"
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
RAM cannula ventilator CPAP
RAM cannula ventilator CPAP
Randomization to CPAP with higher change of impedance as measured by EIT. "Arm A-2"
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
Occlusive interface bubble CPAP
Occlusive interface bubble CPAP
Randomization to standard of care - a 'one size fits all' approach. "Arm B-1"
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
RAM cannula ventilator CPAP
RAM cannula ventilator CPAP
Randomization to standard of care - a 'one size fits all' approach. "Arm B-2"
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
Occlusive interface bubble CPAP
Occlusive interface bubble CPAP
Interventions
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RAM cannula ventilator CPAP
RAM cannula ventilator CPAP
Occlusive interface bubble CPAP
Occlusive interface bubble CPAP
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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.
12 Hours
36 Hours
ALL
No
Sponsors
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Massachusetts General Hospital
OTHER
Responsible Party
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Jessica E Shui, MD
Neonatologist, Assistant Professor of Pediatrics at MGH
Principal Investigators
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Jessica E Shui, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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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.
Prakash 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.
Green 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.
Courtney 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.
Nascimento 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.
Seddon 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.
Bhatia 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.
Other Identifiers
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2023P001796
Identifier Type: -
Identifier Source: org_study_id
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