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NCT03174301: Pre-Vent

Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes

Completed Last updated 2 November 2022
What this trial tests

trial in Infant, Premature in 739 participants. Completed in 4 June 2021.

Timeline
9 March 2018
Primary endpoint
4 June 2021
4 June 2021

Quick facts

Lead sponsorUniversity of Virginia
StatusCompleted
Study typeOBSERVATIONAL
Enrollment739
Start date9 March 2018
Primary completion4 June 2021
Estimated completion4 June 2021
Sites1 location across United States

Conditions studied

Sponsor

University of Virginia

Who can join

Under 1 Week, any sex, with Infant, Premature. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Cardiorespiratory Monitoring Data to Predict Respiratory Outcomes in Extremely Preterm Infants.
    Ambalavanan N, Weese-Mayer DE, Hibbs AM, Claure N, et al · · 2023 · cited 39× · PMID 37219236 · DOI 10.1164/rccm.202210-1971oc
  2. Maturation of cardioventilatory physiological trajectories in extremely preterm infants.
    Weese-Mayer DE, Di Fiore JM, Lake DE, Hibbs AM, et al · · 2024 · cited 19× · PMID 37857848 · DOI 10.1038/s41390-023-02839-0
  3. Apnea, Intermittent Hypoxemia, and Bradycardia Events Predict Late-Onset Sepsis in Infants Born Extremely Preterm.
    Kausch SL, Lake DE, Di Fiore JM, Weese-Mayer DE, et al · · 2024 · cited 8× · PMID 38570031 · DOI 10.1016/j.jpeds.2024.114042
  4. Highly comparative time series analysis of oxygen saturation and heart rate to predict respiratory outcomes in extremely preterm infants.
    Qiu J, Di Fiore JM, Krishnamurthi N, Indic P, et al · · 2024 · cited 3× · PMID 38772400 · DOI 10.1088/1361-6579/ad4e91
  5. Late permissive hypercapnia and respiratory stability among very preterm infants: a pilot randomised trial.
    Travers CP, Carlo WA, Nakhmani A, Laney D, et al · · 2023 · cited 2× · PMID 36914233 · DOI 10.1136/archdischild-2022-325166
  6. Necrotizing Enterocolitis: What's New and What's Next?
    Sha C, Sander WR, Bass K, Hsieh H, et al · · 2025 · cited 1× · PMID 41096926 · DOI 10.3390/ijms26199660
  7. Desaturations with or without Bradycardia Are Associated with Cerebral and Abdominal Hypoxemia: Secondary Analysis of a Randomized Clinical Trial.
    Travers CP, Nakhmani A, Aban I, Laney D, et al · · 2026 · PMID 41615858 · DOI 10.1159/000550648
  8. Control of breathing in preterm infants on incubator oxygen or nasal cannula oxygen.
    Travers CP, Chahine R, Nakhmani A, Aban I, et al · · 2025 · PMID 39147903 · DOI 10.1038/s41390-024-03460-5

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Other recruiting trials for Infant, Premature

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Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing