NCT02983825

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2017

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 21, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2017

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2019

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2020

Completed
6 months until next milestone

Results Posted

Study results publicly available

July 30, 2020

Completed
Last Updated

March 25, 2021

Status Verified

March 1, 2021

Enrollment Period

2.4 years

First QC Date

November 21, 2016

Results QC Date

July 9, 2020

Last Update Submit

March 1, 2021

Conditions

Infant, Premature, DiseasesRespiratory Insufficiency Syndrome of Newborn

Keywords

CPAPBronchopulmonary DysplasiaVentilator Induced Lung InjuryV/Q mismatch

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Best CPAP Level

    variable, up to 2 hours

Study Arms (1)

Continuous positive airway pressure (CPAP) level changes

EXPERIMENTAL

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

Device: Continuous positive airway pressure (CPAP); level changes

Interventions

Continuous positive airway pressure (CPAP); level changesDEVICE

as per arm description

Continuous positive airway pressure (CPAP) level changes

Eligibility Criteria

Age24 Hours - 35 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Born at 27-35 weeks gestational age (GA) by best obstetric estimate, determined by the clinical obstetric team during antepartum admission.
  • Age limits: 24 hours of age - 35 weeks corrected gestational age.
  • On continuous CPAP support between 4-8 cm H2O for greater than 24 hours, as document on the bedside infant flow sheet.
  • 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.

You may not qualify if:

  • Congenital anomalies, as determined by the clinical supervising physician.
  • Current or prior air leak syndrome, as determined by the clinical supervising physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Pennsylvania Hosptital

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

  • 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. 2023 Mar;108(2):188-193. doi: 10.1136/archdischild-2022-324474. Epub 2022 Sep 14.

    PMID: 36104165DERIVED

MeSH Terms

Conditions

Infant, Premature, DiseasesBronchopulmonary DysplasiaVentilator-Induced Lung Injury

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesLung InjuryLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure RespirationRespiration, ArtificialAirway ManagementTherapeuticsRespiratory Therapy

Results Point of Contact

Title
Nicolas Bamat, MD MSCE
Organization
University of Pennsylvania
bamatn@email.chop.edu
2155904010

Study Officials

  • Nicolas Bamat, MD, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2016

First Posted

December 6, 2016

Study Start

February 1, 2017

Primary Completion

July 8, 2019

Study Completion

February 13, 2020

Last Updated

March 25, 2021

Results First Posted

July 30, 2020

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)