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

Not Applicable

Completed

• Conditions: Infant, Premature, Diseases; Respiratory Insufficiency Syndrome of Newborn
• Interventions: Device: Continuous positive airway pressure (CPAP); level changes

• Registration Number: NCT02983825
• Lead Sponsor: Children's Hospital of Philadelphia

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-21
• Study First Submitted QC: 2016-12-01
• Study First Posted: 2016-12-06
• Study Start: 2017-02-01
• Primary Completion: 2019-07-08
• Study Completion: 2020-02-13
• Results First Submitted: 2020-07-09
• Results First Submitted QC: 2020-07-27
• Results First Posted: 2020-07-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Continuous positive airway pressure (CPAP) level changes	Continuous positive airway pressure (CPAP); level changes	Protocol guided changes in CPAP level from clinical baseline, with responsiveness in V/Q mismatch guiding subsequent changes; limited to a range of -2 to +3 cm H2O from baseline

Primary Outcome Measures

Name	Time	Method
Ventilation/Perfusion Mismatch	variable; up to 2 hours	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

Secondary Outcome Measures

Name	Time	Method
Best CPAP Level	variable, up to 2 hours	Defined as the lowest CPAP level associated with an improvement greater than 5% in V/Q mismatch relative to the preceding CPAP level

Trial Locations

Locations (3)

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Pennsylvania Hosptital; 🇺🇸 Philadelphia, Pennsylvania, United States

The Children's Hospital of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States