Analysis of Video Imaging in Newborns

February 16, 2022 updated by: Lama Charafeddine, American University of Beirut Medical Center

Noninvasive Monitoring and Diagnosis of Physiologic Disturbances in Term and Preterm Newborns Using Video Analysis Techniques

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.

Study Overview

Status

Suspended

Conditions

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 Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Lebanon
      • Beirut, Lebanon, 1107 2020
        • American University of Beirut

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 4 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Term and preterm newborns hosted at the AUBMC Neonatal ICU.

Description

Inclusion Criteria:

  • Babies admitted to the neonatal intensive care unit (NICU) at AUBMC.

Exclusion Criteria:

  • Babies with sepsis, respiratory distress, and congenital anomalies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adaptation of the Eulerian Video Magnification monitoring technique for healthy term and preterm neonates.
Time Frame: 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.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adaptation of the Eulerian Video Magnification monitoring technique for diseased term and preterm neonates.
Time Frame: 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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American University of Beirut Medical Center

Collaborators

Lebanese University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2015

Primary Completion (Anticipated)

January 1, 2023

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

December 20, 2016

First Submitted That Met QC Criteria

December 22, 2016

First Posted (Estimate)

December 29, 2016

Study Record Updates

Last Update Posted (Actual)

February 17, 2022

Last Update Submitted That Met QC Criteria

February 16, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PED.LC.06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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