Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes

NCT03174301 | Completed DMC

• 2 other identifiers: 19606U01HL133708
• Study Type: observational
• Target: 739
• Locations: 1 country
• Sites: 1

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.

Conditions

Infant, Premature

Outcome Measures

Primary Outcomes (2)

• 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.

• 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: 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 (#)

  36 weeks and 1 day to 37 weeks and 0 days, post-menstrual age

Secondary Outcomes (5)

• 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

• Age: Up to 1 Week
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Unlikely to survive or decision not to pursue full care
• Major congenital or chromosomal anomaly

Sponsors & Collaborators

• University of Virginia: lead
• Case Western Reserve University: collaborator
• Northwestern University: collaborator
• University of Alabama at Birmingham: collaborator
• University of Miami: collaborator
• Washington University School of Medicine: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator
• Brown University: collaborator

Study Sites (1)

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

Related Publications (3)

• Travers CP, Chahine R, Nakhmani A, Aban I, Carlo WA, Ambalavanan N. Control of breathing in preterm infants on incubator oxygen or nasal cannula oxygen. Pediatr Res. 2025 Feb;97(3):1166-1170. doi: 10.1038/s41390-024-03460-5. Epub 2024 Aug 15.

  PMID: 39147903 DERIVED

• Kausch SL, Lake DE, Di Fiore JM, Weese-Mayer DE, Claure N, Ambalavanan N, Vesoulis ZA, Fairchild KD, Dennery PA, Hibbs AM, Martin RJ, Indic P, Travers CP, Bancalari E, Hamvas A, Kemp JS, Carroll JL, Moorman JR, Sullivan BA; Prematurity-Related Ventilatory Control (Pre-Vent) Investigators. Apnea, Intermittent Hypoxemia, and Bradycardia Events Predict Late-Onset Sepsis in Infants Born Extremely Preterm. J Pediatr. 2024 Aug;271:114042. doi: 10.1016/j.jpeds.2024.114042. Epub 2024 Apr 2.

  PMID: 38570031 DERIVED

• Kausch SL, Lake DE, Di Fiore JM, Weese-Mayer DE, Claure N, Ambalavanan N, Vesoulis ZA, Fairchild KD, Dennery PA, Hibbs AM, Martin RJ, Indic P, Travers CP, Bancalari E, Hamvas A, Kemp JS, Carroll JL, Moorman JR, Sullivan BA; Prematurity-Related Ventilatory Control (Pre-Vent) Investigators. Apnea, Intermittent Hypoxemia, and Bradycardia Events Predict Late-Onset Sepsis in Extremely Preterm Infants. medRxiv [Preprint]. 2024 Jan 27:2024.01.26.24301820. doi: 10.1101/2024.01.26.24301820.

  PMID: 38343825 DERIVED

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: May 19, 2017
• First Posted: June 2, 2017
• Study Start: March 9, 2018
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: November 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)