PEEP and V/Q Mismatch in Premature Infants

NCT03109613 | Terminated Phase 1

• 1 other identifier: 17-013702
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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.

Conditions

Respiratory Insufficiency Syndrome of Newborn; Infant, Premature, Diseases

Keywords

Positive end-expiratory pressure; PEEP; Bronchopulmonary Dysplasia; Ventilator Induced Lung Injury; V/Q mismatch

Outcome Measures

Primary Outcomes (1)

• Feasibility assessed by rate of successfully study enrollment and completion

  Rate of successfully study enrollment and completion

  Full enrollment (12 subjects)

Secondary Outcomes (1)

• Ventilation/perfusion mismatch

  10-20 minutes following each PEEP level change

Study Arms (1)

Positive end-expiratory pressure (PEEP) level changes

EXPERIMENTAL

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)

Interventions

Positive end-expiratory pressure (PEEP) DEVICE

level changes as per arm description

Positive end-expiratory pressure (PEEP) level changes

Eligibility Criteria

• Age: 0 Days - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Hospital of Philadelphia: lead
• Christiana Care Health Services: collaborator

Study Sites (3)

Christiana Care Health System

Newark, Delaware, 19713, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Infant, Premature, Diseases; Bronchopulmonary Dysplasia; Ventilator-Induced Lung Injury

Interventions

Positive-Pressure Respiration

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lung Injury; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Haresh Kirpalani, BM, MSc

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2017
• First Posted: April 12, 2017
• Study Start: April 11, 2016
• Primary Completion: August 8, 2018
• Study Completion: August 8, 2018
• Last Updated: November 17, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)