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Trial record 43 of 47 for:    necrotizing enterocolitis | NIH

Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes (Pre-Vent)

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ClinicalTrials.gov Identifier: NCT03174301
Recruitment Status : Enrolling by invitation
First Posted : June 2, 2017
Last Update Posted : June 4, 2018
Sponsor:
Collaborators:
Case Western Reserve University
Northwestern University
University of Alabama at Birmingham
University of Miami
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Brown University
Information provided by (Responsible Party):
Joseph R Moorman, University of Virginia

Brief Summary:
The objective of this common multicenter protocol is to test the hypothesis that algorithmic tools using clinical Neonatal Intensive Care Unit (NICU) cardiorespiratory monitoring data can detect ventilatory control instability and predict chronic and acute respiratory consequences of ventilatory control instability and autonomic dysregulation.

Condition or disease
Infant, Premature

Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes
Actual Study Start Date : March 9, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : July 2021



Primary Outcome Measures :
  1. Clinical Outcome [ Time Frame: 40 weeks post-menstrual age. ]

    "Favorable": Either (1) an inpatient at 40 weeks post-menstrual age and not on oxygen, nor on other flow/pressure respiratory support, nor on inhaled/oral/IV respiratory medications, OR (2) discharged prior to 40 weeks post-menstrual age not on respiratory meds, oxygen, or other respiratory support.

    "Unfavorable": Either (1) Deceased at 40 weeks , (2) inpatient on meds/O2/support at 40 weeks post-menstrual age, or (3) previously discharged prior to 40 weeks on meds/O2/support


  2. Physiological Outcome [ Time Frame: 36 weeks and 1 day to 37 weeks and 0 days, post-menstrual age ]

    Reported Value will be the percentile value of scores, as plotted on a standard curve of scores for peers. The score is calculated by aggregating the following measurements:

    1. Periodic Breathing Percentage (%)
    2. Number of Apnea events (#)
    3. Number of Bradycardia events (#)
    4. Number of Desaturation events (#)
    5. Number of combined events (example Apnea with Bradycardia and Desaturation (#)


Secondary Outcome Measures :
  1. time on respiratory support and medications [ Time Frame: before 52 weeks post-menstrual age ]
  2. chronic lung disease [ Time Frame: before 52 weeks post-menstrual age ]
  3. pulmonary hypertension [ Time Frame: before 52 weeks post-menstrual age ]
  4. sepsis [ Time Frame: before 52 weeks post-menstrual age ]
  5. necrotizing enterocolitis [ Time Frame: before 52 weeks post-menstrual age ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 1 Week   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All races and ethnicities will be recruited and distribution is expected to be similar to the populations represented in the NICU at each site.

Age of all infants will be less than 29 weeks Gestational Age and less than 1 week Chronological Age, at the time of enrollment.

The study population will be drawn from inpatients in NICUs at participating hospital sites with cardiorespiratory monitoring.

The subjects will be in variable states of health since they are premature and in the intensive care unit.

There will be no pre-screening of infants. Data will be collected on all infants placed in a bed for which monitoring and data collection capabilities are set up. Therefore all such infants will technically be enrolled in the study, regardless of meeting the inclusion/exclusion criteria.

Each enrolled infant will be screened for inclusion/exclusion criteria to determine whether the site will collect further data from the medical record.

Criteria

Inclusion Criteria:

  • Neonatal Intensive Care Unit patient on cardiorespiratory monitor which has been configured to collect data to store for this study
  • < 29 wks Gestational Age
  • < 1 wk Chronological

Exclusion Criteria:

  • Unlikely to survive or decision not to pursue full care
  • Major congenital or chromosomal anomaly

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): NCT03174301


Locations
United States, Virginia
University of Virginia
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of Virginia
Case Western Reserve University
Northwestern University
University of Alabama at Birmingham
University of Miami
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Brown University

Responsible Party: Joseph R Moorman, Professor of Medicine, University of Virginia
ClinicalTrials.gov Identifier: NCT03174301     History of Changes
Other Study ID Numbers: 19606
U01HL133708 ( U.S. NIH Grant/Contract )
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data and linked DNA samples will be stored at NHLBI Biorepository BIO-LINCC. Data will include continuous cardio-respiratory monitoring, demographics, clinical events, co-morbidities, respiratory status, and other clinical data.

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