Analysis of Video Imaging in Newborns

Neonatal Intensive Care Unit Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT03004482
• Other study ID #: PED.LC.06
• Status: Suspended
• Start date: September 2015
• Est. completion date: February 2023

Study information

• Verified date: February 2022
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 80
• Est. completion date: February 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Months

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Neonatal Intensive Care Unit

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut

Sponsors (2)

Lead Sponsor	Collaborator
American University of Beirut Medical Center	Lebanese University

Country where clinical trial is conducted

Lebanon, 

References & Publications (16)

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H.-Y. Wu, M. Rubinstein, E. Shih, J. Guttag, F. Durand, and W. T. Freeman. Eulerian video magnification for revealing subtle changes in the world. ACM Transactions on Graphics, 31(4), 2012.

Heart rate variability: standards of measurement, physiological interpretation and clinical use. Task Force of the European Society of Cardiology and the North American Society of Pacing and Electrophysiology. Circulation. 1996 Mar 1;93(5):1043-65. — View Citation

J. M. Kuller. Skin breakdown: risk factors, prevention and treatment. Newborn Infant Nurs, 1:35-42, 2001. [11] M. L. Neonatal innate immunity to infectious agents. Infection and Immunity, 74:19992006, 2006.

K. J., B. S., G. G., and D. J. Non-contact heart rate and heart rate variability measurements. Biomedical signal processing and control, 13:102-112, 2014.

Kattwinkel J, Perlman JM, Aziz K, Colby C, Fairchild K, Gallagher J, Hazinski MF, Halamek LP, Kumar P, Little G, McGowan JE, Nightengale B, Ramirez MM, Ringer S, Simon WM, Weiner GM, Wyckoff M, Zaichkin J. Part 15: neonatal resuscitation: 2010 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care. Circulation. 2010 Nov 2;122(18 Suppl 3):S909-19. doi: 10.1161/CIRCULATIONAHA.110.971119. Review. Erratum in: Circulation. 2011 Oct 11;124(15):e406. — View Citation

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Moorman JR, Carlo WA, Kattwinkel J, Schelonka RL, Porcelli PJ, Navarrete CT, Bancalari E, Aschner JL, Whit Walker M, Perez JA, Palmer C, Stukenborg GJ, Lake DE, Michael O'Shea T. Mortality reduction by heart rate characteristic monitoring in very low birth weight neonates: a randomized trial. J Pediatr. 2011 Dec;159(6):900-6.e1. doi: 10.1016/j.jpeds.2011.06.044. Epub 2011 Aug 24. — View Citation

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Sullivan BA, Grice SM, Lake DE, Moorman JR, Fairchild KD. Infection and other clinical correlates of abnormal heart rate characteristics in preterm infants. J Pediatr. 2014 Apr;164(4):775-80. doi: 10.1016/j.jpeds.2013.11.038. Epub 2014 Jan 10. — View Citation

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* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adaptation of the Eulerian Video Magnification monitoring technique for healthy term and preterm neonates.	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	Adaptation of the Eulerian Video Magnification monitoring technique for diseased term and preterm neonates.	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