PEEP and V/Q Mismatch in Premature Infants

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

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.

Study Overview

• Status: Terminated
• Conditions: Infant, Premature, Diseases; Respiratory Insufficiency Syndrome of Newborn
• Intervention / Treatment: Device: Positive end-expiratory pressure (PEEP)

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19713
      • Christiana Care Health System
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • The Children's Hospital of Philadelphia
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 4 weeks (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Preterm birth before 32 weeks gestational age by best obstetric estimate, determined by the clinical obstetric team during antepartum admission
2. Birth weight less than 1500 grams, as measured by the clinical team at neonatal admission.
3. Presence of endotracheal intubation and invasive mechanical ventilation
4. Less than or equal to 28 days chronologic age
5. 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:

1. Congenital anomalies, as determined by the clinical supervising physician
2. Current of prior air leak syndrome, as determined by the clinical supervising physician.
3. Non-English speaking parents
4. Non-viable birth, as determined by the clinical supervising physician

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Positive end-expiratory pressure (PEEP) level changes; 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); level changes as per arm description

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

Collaborators and Investigators

• Sponsor: Children's Hospital of Philadelphia
• Collaborators: Christiana Care Health Services
• Investigators: Principal Investigator: Haresh Kirpalani, BM, MSc, University of Pennsylvania

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 11, 2016
• Primary Completion (ACTUAL): August 8, 2018
• Study Completion (ACTUAL): August 8, 2018

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 11, 2017
• First Posted (ACTUAL): April 12, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 17, 2020
• Last Update Submitted That Met QC Criteria: November 16, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: PEEP; Positive end-expiratory pressure; Bronchopulmonary Dysplasia; Ventilator Induced Lung Injury; V/Q mismatch
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Infant, Newborn, Diseases; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Infant, Premature, Diseases; Respiratory Insufficiency; Premature Birth
• Other Study ID Numbers: 17-013702

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No