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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03174301
Other study ID # 19606
Secondary ID U01HL133708
Status Completed
Phase
First received
Last updated
Start date March 9, 2018
Est. completion date June 4, 2021

Study information

Verified date November 2022
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 739
Est. completion date June 4, 2021
Est. primary completion date June 4, 2021
Accepts healthy volunteers No
Gender All
Age group N/A to 1 Week
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Virginia Charlottesville Virginia

Sponsors (8)

Lead Sponsor Collaborator
University of Virginia 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

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Outcome "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
40 weeks post-menstrual age.
Primary Physiological Outcome 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 (#)
36 weeks and 1 day to 37 weeks and 0 days, post-menstrual age
Secondary time on respiratory support and medications before 52 weeks post-menstrual age
Secondary chronic lung disease before 52 weeks post-menstrual age
Secondary pulmonary hypertension before 52 weeks post-menstrual age
Secondary sepsis before 52 weeks post-menstrual age
Secondary necrotizing enterocolitis before 52 weeks post-menstrual age
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