Prematurity-Related Ventilatory Control: Role in Respiratory Outcomes

NCT ID: NCT03174301

Last Updated: 2022-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

739 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-09

Study Completion Date

2021-06-04

Brief Summary

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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

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Conditions

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Infant, Premature

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Maximum Eligible Age

1 Week

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Case Western Reserve University

OTHER

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role collaborator

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role collaborator

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Joseph R Moorman

Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 39147903 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38570031 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38343825 (View on PubMed)

Other Identifiers

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U01HL133708

Identifier Type: NIH

Identifier Source: secondary_id

View Link

19606

Identifier Type: -

Identifier Source: org_study_id

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