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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06038565
Other study ID # 2023P001796
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 18, 2023
Est. completion date October 18, 2024

Study information

Verified date October 2023
Source Massachusetts General Hospital
Contact Jessica E Shui, MD
Phone 617-724-5994
Email jshui@mgh.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date October 18, 2024
Est. primary completion date October 18, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Hours to 36 Hours
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
RAM cannula ventilator CPAP
RAM cannula ventilator CPAP
Occlusive interface bubble CPAP
Occlusive interface bubble CPAP

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary change in electrical impedance change in average electrical impedance with each CPAP delivery modality 2.5 hours during the lung physiology assessment
Primary 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 through study completion, an average of 2 weeks after the lung physiology assessment
Secondary 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) 2.5 hours during the lung physiology assessment
Secondary lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) vascular pulsatility vascular pulsatility (arbitrary units) 2.5 hours during the lung physiology assessment
Secondary 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) 2.5 hours during the lung physiology assessment
Secondary 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) 2.5 hours during the lung physiology assessment
Secondary 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) 2.5 hours during the lung physiology assessment
Secondary lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Respiratory rate Respiratory rate (breaths per minute) 2.5 hours during the lung physiology assessment
Secondary lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Oxygen saturation Oxygen saturation (percentage) 2.5 hours during the lung physiology assessment
Secondary lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) Abdominal circumference Abdominal circumference (cm) 2.5 hours during the lung physiology assessment
Secondary lung physiology measurements (exploratory measures during this pilot study, in preparation for a powered larger trial) esophageal pressure change esophageal pressure change (mm Hg) 2.5 hours during the lung physiology assessment
Secondary 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) 2.5 hours during the lung physiology assessment
Secondary 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) 2.5 hours during the lung physiology assessment
Secondary 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) through study completion, an average of 2 weeks after the lung physiology assessment
Secondary 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) through study completion, an average of 2 weeks after the lung physiology assessment
Secondary 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) through study completion, an average of 2 weeks after the lung physiology assessment
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