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

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.

Study Overview

• Status: Completed
• Conditions: Infant, Premature

• Study Type: Observational
• Enrollment (Actual): 739

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 week (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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 Outcome Measures

Outcome Measure	Time Frame
time on respiratory support and medications	before 52 weeks post-menstrual age
chronic lung disease	before 52 weeks post-menstrual age
pulmonary hypertension	before 52 weeks post-menstrual age
sepsis	before 52 weeks post-menstrual age
necrotizing enterocolitis	before 52 weeks post-menstrual age

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 9, 2018
• Primary Completion (ACTUAL): June 4, 2021
• Study Completion (ACTUAL): June 4, 2021

Study Registration Dates

• First Submitted: May 19, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (ACTUAL): June 2, 2017

Study Record Updates

• Last Update Posted (ACTUAL): November 2, 2022
• Last Update Submitted That Met QC Criteria: November 1, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 19606 (Other Identifier: City of Hope Medical Center); U01HL133708 (NIH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No