Clinical trial NCT06038565: Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates
Official title: Comparing Regional Ventilation in Neonates With Different Delivery Systems of Continuous Positive Airway Pressure
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Prematurity
Respiratory Distress Syndrome
Keywords: continuous positive airway pressure
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-09-15
Enrollment: 0
Sex: ALL
Minimum age (years): 12
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: change in electrical impedance
timeFrame: 2.5 hours during the lung physiology assessment
measure: duration of CPAP treatment
timeFrame: through study completion, an average of 2 weeks after the lung physiology assessment
Secondary outcomes:
measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in end expiratory lung impedance
timeFrame: 2.5 hours during the lung physiology assessment
measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) vascular pulsatility
timeFrame: 2.5 hours during the lung physiology assessment
measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) tidal volume
timeFrame: 2.5 hours during the lung physiology assessment
measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in minute ventilation
timeFrame: 2.5 hours during the lung physiology assessment
measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) change in dynamic compliance
timeFrame: 2.5 hours during the lung physiology assessment
measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Respiratory rate
timeFrame: 2.5 hours during the lung physiology assessment
measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Oxygen saturation
timeFrame: 2.5 hours during the lung physiology assessment
measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Abdominal circumference
timeFrame: 2.5 hours during the lung physiology assessment
measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) esophageal pressure change
timeFrame: 2.5 hours during the lung physiology assessment
measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) end expiratory pressure
timeFrame: 2.5 hours during the lung physiology assessment
measure: lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) pressure rate product
timeFrame: 2.5 hours during the lung physiology assessment
measure: clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) Frequency of deviation
timeFrame: through study completion, an average of 2 weeks after the lung physiology assessment
measure: clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial) frequency of exogenous surfactant administration
timeFrame: through study completion, an average of 2 weeks after the lung physiology assessment
measure: clinical outcomes of different CPAP modalities (exploratory measures during this pilot study, in preparation for a powered larger trial)
timeFrame: through study completion, an average of 2 weeks after the lung physiology assessment
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Jessica E Shui, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.