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

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ClinicalTrials.gov Identifier: NCT02983825
Recruitment Status : Completed
First Posted : December 6, 2016
Results First Posted : July 30, 2020
Last Update Posted : March 25, 2021
Sponsor:
Collaborator:
Thrasher Research Fund
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Tracking Information
First Submitted Date  ICMJE November 21, 2016
First Posted Date  ICMJE December 6, 2016
Results First Submitted Date  ICMJE July 9, 2020
Results First Posted Date  ICMJE July 30, 2020
Last Update Posted Date March 25, 2021
Actual Study Start Date  ICMJE February 1, 2017
Actual Primary Completion Date July 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 9, 2020)
Ventilation/Perfusion Mismatch [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
Ventilation/perfusion mismatch [ Time Frame: 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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 9, 2020)
Best CPAP Level [ Time Frame: 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
Original Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2016)
Best CPAP level [ Time Frame: 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
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact of CPAP Level on V/Q Mismatch in Premature Infants
Official Title  ICMJE Impact of Continuous Positive Airway Pressure Level on Ventilation/Perfusion Mismatch in Premature Infants: a Phase II Clinical Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Infant, Premature, Diseases
  • Respiratory Insufficiency Syndrome of Newborn
Intervention  ICMJE Device: Continuous positive airway pressure (CPAP); level changes
as per arm description
Study Arms  ICMJE Experimental: 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
Intervention: Device: Continuous positive airway pressure (CPAP); level changes
Publications * Bamat NA, Orians CM, Abbasi S, Morley CJ, Ross Russell R, Panitch HB, Handley SC, Foglia EE, Posencheg MA, Kirpalani H. Use of ventilation/perfusion mismatch to guide individualised CPAP level selection in preterm infants: a feasibility trial. Arch Dis Child Fetal Neonatal Ed. 2022 Sep 14:fetalneonatal-2022-324474. doi: 10.1136/archdischild-2022-324474. Online ahead of print.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2020)
21
Original Estimated Enrollment  ICMJE
 (submitted: December 1, 2016)
20
Actual Study Completion Date  ICMJE February 13, 2020
Actual Primary Completion Date July 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 24 Hours to 35 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02983825
Other Study ID Numbers  ICMJE 17-013910
825874 ( Other Identifier: University of Pennsylvania )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Children's Hospital of Philadelphia
Original Responsible Party University of Pennsylvania
Current Study Sponsor  ICMJE Children's Hospital of Philadelphia
Original Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Thrasher Research Fund
Investigators  ICMJE
Principal Investigator: Nicolas Bamat, MD, MSCE University of Pennsylvania
PRS Account Children's Hospital of Philadelphia
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP