Infant, Premature
Conditions
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.
Interventions
None listed
Sponsors
Case Western Reserve University
Northwestern University
University of Alabama at Birmingham
University of Miami
Washington University School of Medicine
National Heart, Lung, and Blood Institute (NHLBI)
Brown University
University of Virginia
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 1 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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: 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 (#) |
Secondary
| Measure | Time frame |
|---|---|
| pulmonary hypertension | before 52 weeks post-menstrual age |
| time on respiratory support and medications | before 52 weeks post-menstrual age |
| necrotizing enterocolitis | before 52 weeks post-menstrual age |
| sepsis | before 52 weeks post-menstrual age |
| chronic lung disease | before 52 weeks post-menstrual age |
Countries
United States
Outcome results
None listed