Analysis of Video Imaging in Newborns

Sponsor
American University of Beirut Medical Center (Other)
Overall Status
Suspended
CT.gov ID
NCT03004482
Collaborator
Lebanese University (Other)
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Study Details

Study Description

Brief Summary

Video recording for term and preterm newborns hosted at the AUBMC Neonate ICU will be collected. The videos will capture movements, skin color changes, positioning, and other features relevant to the diagnosis in question. Recorded video images will be analysed by a computer software using the Eulerian Video magnification technology; then images will be correlated with simultaneously recorded physiological parameters (heart rate, respiratory rate and saturation). Images will be annotated by the clinician. Correlation between the skin coloration differentials and annotated physiological parameters may establish physiological indices. These may be used to extrapolate the existence or absence of disease states.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Recent medical and technological advancements are progressively leading to increased survival rates of term and premature neonates. This project is concerned with detecting early signs of physiological disorders in term and preterm babies based on Eulerian Video Magnification, statistical analysis, and expert knowledge. Video recordings of skin coloration differentials for normal and sick neonates may be used to establish norms for each of the two major populations. Those and possibly other features will be used to develop an automatic contactless, noninvasive monitoring and diagnostic system that may detect early signs of disease. Early detection may lead to early diagnosis and preemptive treatment resulting in better outcome and lower costs of medical intervention. The objective of this project is to adapt the Eulerian Video Magnification for monitoring physiologic changes and then diagnosing potential disturbances in term and preterm neonates of different gestational ages. EVM uses video recordings of magnified skin color signals over time and thus permits analysis of physiological state changes such as heart rate and perfusion. Those changes would then be correlated with particular condition or disease states for the purpose of automatic early diagnosis and alarm issuance. Being contactless and non-invasive, the proposed system would be particularly helpful in vulnerable populations such as sick neonates. It may lead to earlier treatment, improved outcome, and possibly, decreased hospital stay.

    Parents of infants admitted to the neonatal intensive care unit (NICU) at AUBMC will be informed about the study by their Attending physician. The medical research assistant will approach only interested and potential participants. An informed consent will be obtained prior to enrollment. All infants admitted to the NICU are eligible. Those will be divided into four equal groups: 1) "normal" term, 2) "normal" preterm, 3) "sick" term, and 4) "sick" preterm babies, where a "normal" health state is defined by the medical team as "physiologically stable". The medical team considers "sick" state based on pathological symptoms such as bradycardia, apnea, and hypotension among others. We target collecting video recordings for a total of eighty babies as a pilot number over the period of eight months. Each baby will be recorded for a minimum of twenty four hours. A subset of the eighty babies will be considered as a control group for reference. The control group will be selected based on a normal physiological state excluding babies with sepsis, respiratory distress, and congenital anomalies.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    80 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Noninvasive Monitoring and Diagnosis of Physiologic Disturbances in Term and Preterm Newborns Using Video Analysis Techniques
    Study Start Date :
    Sep 1, 2015
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Adaptation of the Eulerian Video Magnification monitoring technique for healthy term and preterm neonates. [2 years]

      Using EVM technology, variations in magnified skin color differentials will be used to establish norms by correlating image variation signals with physiological parameters in healthy infants.

    Secondary Outcome Measures

    1. Adaptation of the Eulerian Video Magnification monitoring technique for diseased term and preterm neonates. [2 years]

      Using EVM technology, variations in magnified skin color differentials in diseased infants will be compared to the previously establish norms in order to permit early detection of changes in the physiological parameters in diseased infants.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Hour to 4 Months
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Babies admitted to the neonatal intensive care unit (NICU) at AUBMC.
    Exclusion Criteria:
    • Babies with sepsis, respiratory distress, and congenital anomalies.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 American University of Beirut Beirut Lebanon 1107 2020

    Sponsors and Collaborators

    • American University of Beirut Medical Center
    • Lebanese University

    Investigators

    • Principal Investigator: Lama Charafeddine, MD FAAP, American University of Beirut Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Lama Charafeddine, Associate Professor of Clinical Pediatrics, American University of Beirut Medical Center
    ClinicalTrials.gov Identifier:
    NCT03004482
    Other Study ID Numbers:
    • PED.LC.06
    First Posted:
    Dec 29, 2016
    Last Update Posted:
    Feb 17, 2022
    Last Verified:
    Feb 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Lama Charafeddine, Associate Professor of Clinical Pediatrics, American University of Beirut Medical Center

    Study Results

    No Results Posted as of Feb 17, 2022