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

Sponsor

University of Virginia (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03174301

Collaborator

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

739

Enrollment

Location

51.7

Anticipated Duration (Months)

14.3

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
Infant, Premature

Study Design

Study Type:

Observational

Actual Enrollment :

739 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes

Actual Study Start Date :

Mar 9, 2018

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Outcome Measures

Primary Outcome Measures

Clinical Outcome [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
Physiological Outcome [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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 1 Week

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Virginia	Charlottesville	Virginia	United States	22908

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joseph R Moorman, Professor of Medicine, University of Virginia

ClinicalTrials.gov Identifier:

NCT03174301

Other Study ID Numbers:

19606
U01HL133708

First Posted:

Jun 2, 2017

Last Update Posted:

Mar 9, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Premature Birth

Study Results

No Results Posted as of Mar 9, 2022