PEEP and V/Q Mismatch in Premature Infants

Study Overview
=================
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.

Official Title
-----------------
Selecting PEEP in Ventilated Premature Infants by Reducing Ventilation/Perfusion Mismatch: a Pilot Feasibility Study

Conditions
-----------------
Respiratory Insufficiency Syndrome of Newborn, Infant, Premature, Diseases

Intervention / Treatment
-----------------
* Device: Positive end-expiratory pressure (PEEP)


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 28 Days

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Positive end-expiratory pressure (PEEP) level changes<br>Sequential changes in PEEP level within range of 4-8 cm H2O followed by measurement of V/Q mismatch at each level. | Device: Positive end-expiratory pressure (PEEP)<br>* level changes as per arm description<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility assessed by rate of successfully study enrollment and completion | Rate of successfully study enrollment and completion | Full enrollment (12 subjects) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10-20 minutes following each PEEP level change | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Positive end-expiratory pressure, PEEP, Bronchopulmonary Dysplasia, Ventilator Induced Lung Injury, V/Q mismatch