Impact of CPAP Level on V/Q Mismatch in Premature Infants

Infant, Premature, Diseases Clinical Trial

Official title:

Impact of Continuous Positive Airway Pressure Level on Ventilation/Perfusion Mismatch in Premature Infants: a Phase II Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983825
• Other study ID #: 17-013910
• Secondary ID: 825874
• Status: Completed
• Phase: N/A
• Start date: February 1, 2017
• Est. completion date: February 13, 2020

Study information

• Verified date: March 2021
• Source: Children's Hospital of Philadelphia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Continuous positive airway pressure (CPAP) is used in premature infants to maintain lungs open and facilitate gas exchange. When ventilation/perfusion (V/Q) mismatch is present, areas of the lung that are open for gas exchange do not match up with the areas of the lung that are receiving blood for gas exchange. This study measure the responsiveness of V/Q mismatch to changes in the amount (or level) of CPAP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 13, 2020
• Est. primary completion date: July 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 35 Weeks

Eligibility

Inclusion Criteria:

1. Born at 27-35 weeks gestational age (GA) by best obstetric estimate, determined by the clinical obstetric team during antepartum admission.

2. Age limits: 24 hours of age - 35 weeks corrected gestational age.

3. On continuous CPAP support between 4-8 cm H2O for greater than 24 hours, as document on the bedside infant flow sheet.

4. Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) 0.25 for at least 2 consecutive hours, as documented on the bedside infant flow sheet.

Exclusion Criteria:

1. Congenital anomalies, as determined by the clinical supervising physician.

2. Current or prior air leak syndrome, as determined by the clinical supervising physician.

Related Conditions & MeSH terms

• Infant, Premature, Diseases
• Premature Birth
• Pulmonary Valve Insufficiency
• Respiratory Insufficiency
• Respiratory Insufficiency Syndrome of Newborn

Intervention

Device:
• Continuous positive airway pressure (CPAP); level changes
as per arm description

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Pennsylvania Hosptital	Philadelphia	Pennsylvania
United States	The Children's Hospital of Philadelphia	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital of Philadelphia	Thrasher Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilation/Perfusion Mismatch	Measured by non-invasive computerized technique based on curvilinear characteristics generated by a best-fit curve connecting the fractional inspired oxygen and corresponding peripheral oxygen saturation pairs; measured as difference in degree of right-shift between baseline and "best" CPAP	variable; up to 2 hours
Secondary	Best CPAP Level	Defined as the lowest CPAP level associated with an improvement greater than 5% in V/Q mismatch relative to the preceding CPAP level	variable, up to 2 hours