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OpenTrials
Completed

NCT Number: NCT03174301

Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes

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.

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Key information

Conditions

Infant, Premature Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

Up to 1 week

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Virginia

Charlottesville, Virginia, 22908, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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:

    • Periodic Breathing Percentage (%)
    • Number of Apnea events (#)
    • Number of Bradycardia events (#)
    • Number of Desaturation events (#)
    • Number of combined events (example Apnea with Bradycardia and Desaturation (#)

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Brown University
  • Case Western Reserve University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Northwestern University
  • University of Alabama at Birmingham
  • University of Miami
  • Washington University School of Medicine

Registry information

Acronym: Pre-Vent

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jun 2, 2017
Registry last updated
Nov 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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