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Trial record 11 of 210 for:    Recruiting, Not yet recruiting, Available Studies | "Infant, Premature, Diseases"

Pulmonary Function Using Non-invasive Forced Oscillometry (PUFFOR)

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ClinicalTrials.gov Identifier: NCT03346343
Recruitment Status : Recruiting
First Posted : November 17, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Colm Travers, University of Alabama at Birmingham

Brief Summary:
The purpose of this observational study is to measure pulmonary function in term and preterm infants with and without pulmonary disease including respiratory distress syndrome, bronchopulmonary dysplasia, transient tachypnea of the newborn, meconium aspiration syndrome, and response to treatments given to newborn infants with lung diseases using a non-invasive airway oscillometry system.

Condition or disease Intervention/treatment Phase
Infant, Premature, Diseases Infant, Newborn, Diseases Bronchopulmonary Dysplasia Respiratory Distress Syndrome, Newborn Meconium Aspiration Syndrome Transient Tachypnea of the Newborn Device: Non-invasive forced airway oscillometry Not Applicable

Detailed Description:

TremoFlo™ C-100 Airwave Oscillometry System™ (THORASYS Thoracic Medical Systems Inc. Montreal, Quebec, Canada) is a technology for measuring lung mechanics without patient effort. Pulmonary function testing using flow-volume and lung volumes is one of the most widely used tests to objectively measure lung function in adults. Such measurements are dependent on effort and coordination by the patient which is not possible for newborn infants. The minimum age for spirometry is typically 6 years to master the technique. Therefore, newborn infants usually require forced exhalation, flow interruption, and often sedation/anesthesia in order to obtain accurate pulmonary function measurements. Infant pulmonary function testing can be time-consuming and expensive to perform in newborn infants. This has limited the utilization of this potentially informative method of studying lung function. Measurements of lung function will be particularly informative during transition from having lungs filled with fluid during intra-uterine life to having lungs filled with air in extra-uterine life in preterm and term babies without lung disease, as well as in newborn infants with lung diseases including respiratory distress syndrome, bronchopulmonary dysplasia, transient tachypnea of the newborn, meconium aspiration syndrome, and after the effects of treatments given to newborn infants with lung diseases.

The TremoFlo device uses the forced oscillation technique during spontaneous infant breathing and notably does not require any sedation to perform. The forced oscillation technique measures lung function by superimposing a gentle multi-frequency airwave onto the infant's respiratory airflow while the infant breathes spontaneously. Only a short period of breathing is required to obtain a reliable measurement of airway resistance and reactance. Oscillometry has been successfully utilized to quantify lung function in asthmatic children and adults with chronic obstructive pulmonary disease, but never previously in infants. This proposal brings this non-invasive technique of measuring lung function to the neonatal population to identify changes in respiratory mechanics between term and pre-term gestations and quantify fluctuations in infant lung function in response to disease progression and therapeutic intervention. The ease of oscillometry that only requires tidal breathing eliminates the need for patient cooperation and maneuvers that previously excluded lung function testing in the neonatal intensive care unit. This proposal will evaluate the feasibility and clinical value of oscillometry in newborns, both to detect changes in premature compared to full-term gestations as well as disease cohorts by introducing functional measures of lung function to bedside care.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1098 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This will be a single center prospective observational study with pre-specified Aims and Hypotheses
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pulmonary Function Using Non-invasive Forced Oscillometry Respiratory Testing: A Prospective Observational Study
Actual Study Start Date : December 6, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : May 2021


Arm Intervention/treatment
Experimental: Non-invasive forced airway oscillometry

Analyze lung function using forced airway oscillometry in preterm infants and term infants with and without lung disease with both cross-sectional and longitudinal comparisons.

Aim 1: Lung function in term and preterm infants without lung disease (anticipated n=264) Aim 2: Lung function in preterm infants with respiratory distress syndrome (RDS) who develop bronchopulmonary dysplasia (BPD) and preterm infants with RDS who do not develop BPD (anticipated n=264) Aim 3: Lung function measurements in infants with common neonatal lung diseases (including RDS, BPD, meconium aspiration syndrome, and transient tachypnea of the newborn) and controls without lung disease (anticipated n=570) Aim 4: Lung function in infants with lung disease before and after common therapeutic interventions

Device: Non-invasive forced airway oscillometry
This is a non-invasive device will measure lung function in spontaneously breathing infants. Infants will have a cushioned mask placed on his/her face and the device will take measurements as the infant breathes normally.




Primary Outcome Measures :
  1. Change over time in Lung Reactance x7 quantified by oscillometry [ Time Frame: Day 1, day 2, day 3, day 4, day 7, and weekly thereafter up to 20 weeks ]
    Change over time in Lung reactance at 7 Hz quantified by oscillometry


Secondary Outcome Measures :
  1. Change over time in Resistance r7 quantified by oscillometry [ Time Frame: Day 1, day 2, day 3, day 4, day 7, and weekly thereafter up to 20 weeks ]
    Change over time in Lung resistance at r7 quantified by oscillometry

  2. Change over time in Resistance r13 quantified by oscillometry [ Time Frame: Day 1, day 2, day 3, day 4, day 7, and weekly thereafter up to 20 weeks ]
    Change over time in Lung resistance at r13 quantified by oscillometry

  3. Change over time in Resistance r19 quantified by oscillometry [ Time Frame: Day 1, day 2, day 3, day 4, day 7, and weekly thereafter up to 20 weeks ]
    Change over time in Lung resistance at r19 quantified by oscillometry

  4. Change over time in Reactance x13 quantified by oscillometry [ Time Frame: Day 1, day 2, day 3, day 4, day 7, and weekly thereafter up to 20 weeks ]
    Change over time in Lung reactance at 13 Hz quantified by oscillometry

  5. Change over time in Reactance x19 quantified by oscillometry [ Time Frame: Day 1, day 2, day 3, day 4, day 7, and weekly thereafter up to 20 weeks ]
    Change over time in Lung reactance at 19 Hz quantified by oscillometry

  6. Change over time in Impedance R(f) quantified by oscillometry [ Time Frame: Day 1, day 2, day 3, day 4, day 7, and weekly thereafter up to 20 weeks ]
    Change over time in Resistance as a function of frequency R(f) quantified by oscillometry

  7. Change over time in Impedance x(f) quantified by oscillometry [ Time Frame: Day 1, day 2, day 3, day 4, day 7, and weekly thereafter up to 20 weeks ]
    Change over time in Reactance as a function of frequency x(f) quantified by oscillometry

  8. Change over time in Coherence quantified by oscillometry [ Time Frame: Day 1, day 2, day 3, day 4, day 7, and weekly thereafter up to 20 weeks ]
    Change over time in Coherence at each frequency Coh(f) quantified by oscillometry

  9. Change over time in Resonance frequency quantified by oscillometry [ Time Frame: Day 1, day 2, day 3, day 4, day 7, and weekly thereafter up to 20 weeks ]
    Change over time in Resonance frequency quantified by oscillometry

  10. Change over time in Reactance area quantified by oscillometry [ Time Frame: Day 1, day 2, day 3, day 4, day 7, and weekly thereafter up to 20 weeks ]
    Change over time in Reactance area AX7 quantified by oscillometry

  11. Change over time in Reactance difference quantified by oscillometry [ Time Frame: Day 1, day 2, day 3, day 4, day 7, and weekly thereafter up to 20 weeks ]
    Change over time in Reactance difference DeltaX7 quantified by oscillometry

  12. Change over time in Tidal volume quantified by oscillometry [ Time Frame: Day 1, day 2, day 3, day 4, day 7, and weekly thereafter up to 20 weeks ]
    Change over time in Tidal volume measured in mL/kg quantified by oscillometry

  13. Change over time in Respiratory rate quantified by oscillometry [ Time Frame: Day 1, day 2, day 3, day 4, day 7, and weekly thereafter up to 20 weeks ]
    Change over time in Respiratory rate in breaths per minute quantified by oscillometry



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Ages Eligible for Study:   up to 120 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants with gestational age at least 22 weeks at birth
  • Infants off ventilator/continuous positive airway pressure ≥ 12 hours
  • Infants whose parents/legal guardians have provided consent

Exclusion Criteria:

  • Infants with major malformation
  • Infants with a neuromuscular condition that affects respiration
  • Infants with terminal illness
  • Infants with a decision made to withhold or limit support

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): NCT03346343


Contacts
Contact: Colm P Travers, MD 205 9344680 ctravers@peds.uab.edu
Contact: Tara McNair, RN 2059344680 tmcnair@peds.uab.edu

Locations
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Colm P Travers, MD    205-934-4680    ctravers@peds.uab.edu   
Contact: Tara E McNair, RN    205 923 4680    temcnair@uab.edu   
Sponsors and Collaborators
University of Alabama at Birmingham
Investigators
Study Director: Namasivayam Ambalavanan, MD University of Alabama at Birmingham

Responsible Party: Colm Travers, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03346343     History of Changes
Other Study ID Numbers: IRB-300000296
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
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
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Infant, Premature, Diseases
Syndrome
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Bronchopulmonary Dysplasia
Tachypnea
Infant, Newborn, Diseases
Meconium Aspiration Syndrome
Transient Tachypnea of the Newborn
Disease
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Ventilator-Induced Lung Injury
Lung Injury
Signs and Symptoms, Respiratory
Signs and Symptoms
Fetal Diseases
Pregnancy Complications