Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes

Completed

• Conditions: Infant, Premature

• Registration Number: NCT03174301
• Lead Sponsor: University of Virginia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-19
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-06-02
• Study Start: 2018-03-09
• Primary Completion: 2021-06-04
• Study Completion: 2021-06-04
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-01
• Last Update Posted: 2022-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 739

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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: 1. Periodic Breathing Percentage (%); 2. Number of Apnea events (#); 3. Number of Bradycardia events (#); 4. Number of Desaturation events (#); 5. Number of combined events (example Apnea with Bradycardia and Desaturation (#)
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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States