NCT02983825

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

Completed NA Results posted Last updated 25 March 2021

What this trial tests

NA trial testing Continuous positive airway pressure (CPAP); level changes in Infant, Premature, Diseases in 21 participants. Completed in 13 February 2020.

Timeline

1 February 2017

Primary endpoint
8 July 2019

13 February 2020

Quick facts

Lead sponsor	Children's Hospital of Philadelphia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	21
Start date	1 February 2017
Primary completion	8 July 2019
Estimated completion	13 February 2020
Sites	3 locations across United States

Drugs / interventions tested

• Continuous positive airway pressure (CPAP); level changes

Conditions studied

• Infant, Premature, Diseases — all drugs for Infant, Premature, Diseases →
• Respiratory Insufficiency Syndrome of Newborn — all drugs for Respiratory Insufficiency Syndrome of Newborn →

Sponsor

Children's Hospital of Philadelphia

Who can join

Adults 24 Hours to 35 Weeks, any sex, with Infant, Premature, Diseases or Respiratory Insufficiency Syndrome of Newborn. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Ventilation/Perfusion Mismatch Primary · 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

Group	Value	95% CI
Continuous Positive Airway Pressure (CPAP) Level Changes	1.2	0 – 3.2

Best CPAP Level Secondary · 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

Group	Value	95% CI
Continuous Positive Airway Pressure (CPAP) Level Changes	7	7 – 8

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Use of ventilation/perfusion mismatch to guide individualised CPAP level selection in preterm infants: a feasibility trial.
   Bamat NA, Orians CM, Abbasi S, Morley CJ, et al · · 2023 · cited 3× · PMID 36104165 · DOI 10.1136/archdischild-2022-324474