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Trial record 7 of 212 for:    Recruiting, Not yet recruiting, Available Studies | "Infant, Premature, Diseases"

PEEP and V/Q Mismatch in Premature Infants

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ClinicalTrials.gov Identifier: NCT03109613
Recruitment Status : Recruiting
First Posted : April 12, 2017
Last Update Posted : May 2, 2018
Sponsor:
Collaborators:
Children's Hospital of Philadelphia
Christiana Care Health Services
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Respiratory Insufficiency Syndrome of Newborn Infant, Premature, Diseases Device: Positive end-expiratory pressure (PEEP) Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Selecting PEEP in Ventilated Premature Infants by Reducing Ventilation/Perfusion Mismatch: a Pilot Feasibility Study
Actual Study Start Date : April 11, 2016
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Feasibility assessed by rate of successfully study enrollment and completion [ Time Frame: Full enrollment (12 subjects) ]
    Rate of successfully study enrollment and completion


Secondary Outcome Measures :
  1. Ventilation/perfusion mismatch [ Time Frame: 10-20 minutes following each PEEP level change ]
    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



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Ages Eligible for Study:   up to 28 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03109613


Contacts
Contact: Nicolas Bamat, MD 2153001356 bamatn@email.chop.edu
Contact: Haresh Kirpalani, BM, MSc 215-977-9779 kirpalanih@email.chop.edu

Locations
United States, Delaware
Christiana Care Health System Not yet recruiting
Newark, Delaware, United States, 19713
Contact: Ursula Guillen, MD    302-733-2410      
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nicolas Bamat, MD       bamatn@email.chop.edu   
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Nicolas Bamat, MD    215-300-1356    bamatn@email.chop.edu   
Sponsors and Collaborators
University of Pennsylvania
Children's Hospital of Philadelphia
Christiana Care Health Services
Investigators
Principal Investigator: Haresh Kirpalani, BM, MSc University of Pennsylvania

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03109613     History of Changes
Other Study ID Numbers: 824236
First Posted: April 12, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Pennsylvania:
Positive end-expiratory pressure
PEEP
Bronchopulmonary Dysplasia
Ventilator Induced Lung Injury
V/Q mismatch

Additional relevant MeSH terms:
Infant, Premature, Diseases
Premature Birth
Respiratory Insufficiency
Pulmonary Valve Insufficiency
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Respiration Disorders
Respiratory Tract Diseases
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Infant, Newborn, Diseases