Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes

Infant, Premature Clinical Trial

— Pre-Vent  

Official title:

Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174301
• Other study ID #: 19606
• Secondary ID: U01HL133708
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Infant, Premature
• Premature Birth

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