Clinical trial NCT03174301: Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes
Official title: Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infant, Premature
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: Case Western Reserve University
name: Northwestern University
name: University of Alabama at Birmingham
name: University of Miami
name: Washington University School of Medicine
name: National Heart, Lung, and Blood Institute (NHLBI)
name: Brown University
First posted: 2017-06-02
Enrollment: 739
Sex: ALL
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Clinical Outcome
timeFrame: 40 weeks post-menstrual age.
measure: Physiological Outcome
timeFrame: 36 weeks and 1 day to 37 weeks and 0 days, post-menstrual age
Secondary outcomes:
measure: time on respiratory support and medications
timeFrame: before 52 weeks post-menstrual age
measure: chronic lung disease
timeFrame: before 52 weeks post-menstrual age
measure: pulmonary hypertension
timeFrame: before 52 weeks post-menstrual age
measure: sepsis
timeFrame: before 52 weeks post-menstrual age
measure: necrotizing enterocolitis
timeFrame: before 52 weeks post-menstrual age
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References: