Status:
WITHDRAWN
Comparing Different Delivery Systems of Continuous Positive Airway Pressure in Neonates
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Prematurity
Respiratory Distress Syndrome
Eligibility:
All Genders
12-36 years
Phase:
NA
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 answ...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 11 2024
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06038565
Start Date
October 18 2023
End Date
April 11 2024
Last Update
July 8 2024
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114