Back to resultsPEEP and V/Q Mismatch in Premature Infants
Primary Purpose
Respiratory Insufficiency Syndrome of Newborn, Infant, Premature, Diseases
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Positive end-expiratory pressure (PEEP)
Sponsored by
About this trial
This is an interventional treatment trial for Respiratory Insufficiency Syndrome of Newborn focused on measuring Positive end-expiratory pressure, PEEP, Bronchopulmonary Dysplasia, Ventilator Induced Lung Injury, V/Q mismatch
Eligibility Criteria
Inclusion Criteria:
- Preterm birth before 32 weeks gestational age by best obstetric estimate, determined by the clinical obstetric team during antepartum admission
- Birth weight less than 1500 grams, as measured by the clinical team at neonatal admission.
- Presence of endotracheal intubation and invasive mechanical ventilation
- Less than or equal to 28 days chronologic age
- Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) equal to or greater than 0.25 as documented on the bedside infant flow sheet.
Exclusion Criteria:
- Congenital anomalies, as determined by the clinical supervising physician
- Current of prior air leak syndrome, as determined by the clinical supervising physician.
- Non-English speaking parents
- Non-viable birth, as determined by the clinical supervising physician
Sites / Locations
- Christiana Care Health System
- Hospital of the University of Pennsylvania
- The Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Positive end-expiratory pressure (PEEP) level changes
Arm Description
Sequential changes in PEEP level within range of 4-8 cm H2O followed by measurement of V/Q mismatch at each level.
Outcomes
Primary Outcome Measures
Feasibility assessed by rate of successfully study enrollment and completion
Rate of successfully study enrollment and completion
Secondary Outcome Measures
Ventilation/perfusion mismatch
Measured by non-invasive computerized technique based of curvilinear characteristics generated by a best-fit curve connection the fractional inspired oxygen and corresponding peripheral oxygen saturation pairs
Full Information
NCT ID
NCT03109613
First Posted
April 6, 2017
Last Updated
November 16, 2020
Sponsor
Children's Hospital of Philadelphia
Collaborators
Christiana Care Health Services
1. Study Identification
Unique Protocol Identification Number
NCT03109613
Brief Title
PEEP and V/Q Mismatch in Premature Infants
Official Title
Selecting PEEP in Ventilated Premature Infants by Reducing Ventilation/Perfusion Mismatch: a Pilot Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
Inadequate enrollment
Study Start Date
April 11, 2016 (Actual)
Primary Completion Date
August 8, 2018 (Actual)
Study Completion Date
August 8, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
Christiana Care Health Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Positive end-expiratory pressure (PEEP) is used in premature infants receiving mechanical ventilation to maintain lungs open and facilitate gas exchange. When ventilation/perfusion mismatch is present, areas of the lung that are open for gas exchange do not match up with areas of the lung that are receiving blood for gas exchange. This study measures the feasibility of enrolling and completing study maneuvers in premature infants for a prospective study measuring the responsiveness of V/Q mismatch to changes in the amount (or level) of PEEP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Insufficiency Syndrome of Newborn, Infant, Premature, Diseases
Keywords
Positive end-expiratory pressure, PEEP, Bronchopulmonary Dysplasia, Ventilator Induced Lung Injury, V/Q mismatch
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Positive end-expiratory pressure (PEEP) level changes
Arm Type
Experimental
Arm Description
Sequential changes in PEEP level within range of 4-8 cm H2O followed by measurement of V/Q mismatch at each level.
Intervention Type
Device
Intervention Name(s)
Positive end-expiratory pressure (PEEP)
Intervention Description
level changes as per arm description
Primary Outcome Measure Information:
Title
Feasibility assessed by rate of successfully study enrollment and completion
Description
Rate of successfully study enrollment and completion
Time Frame
Full enrollment (12 subjects)
Secondary Outcome Measure Information:
Title
Ventilation/perfusion mismatch
Description
Measured by non-invasive computerized technique based of curvilinear characteristics generated by a best-fit curve connection the fractional inspired oxygen and corresponding peripheral oxygen saturation pairs
Time Frame
10-20 minutes following each PEEP level change
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Days
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Preterm birth before 32 weeks gestational age by best obstetric estimate, determined by the clinical obstetric team during antepartum admission
Birth weight less than 1500 grams, as measured by the clinical team at neonatal admission.
Presence of endotracheal intubation and invasive mechanical ventilation
Less than or equal to 28 days chronologic age
Supplemental oxygen requirement, with a fraction of inspired oxygen (FiO2) equal to or greater than 0.25 as documented on the bedside infant flow sheet.
Exclusion Criteria:
Congenital anomalies, as determined by the clinical supervising physician
Current of prior air leak syndrome, as determined by the clinical supervising physician.
Non-English speaking parents
Non-viable birth, as determined by the clinical supervising physician
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haresh Kirpalani, BM, MSc
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Christiana Care Health System
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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PEEP and V/Q Mismatch in Premature Infants
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