Neonatal Intensive Care UnitNCT03004482
Analysis of Video Imaging in Newborns
An observational study of Neonatal Intensive Care Unit, run by American University of Beirut Medical Center at 1 site in Lebanon.
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. Read more about this study
- Who is it for?
- Ages 1 hour to 4 months
- Conditions the study is for
- Neonatal Intensive Care Unit
- How many people
- 80 participants
- Where
- 1 siteLebanon
- Study dates
- Sep 2015to Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 4 months
- All sexes
- No healthy volunteers
- Child
Study population: Term and preterm newborns hosted at the AUBMC Neonatal ICU.
Who may be able to join
- Babies admitted to the neonatal intensive care unit (NICU) at AUBMC.
Who cannot join
- Babies with sepsis, respiratory distress, and congenital anomalies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Neonatal Intensive Care Unit
- Keywords
- NICU, Recorded video images, physiological disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2016 (estimated)
- Study startSep 2015
- Primary completionJan 2023 (estimated)
- Study completionFeb 2023 (estimated)
Why it stopped: lack of Funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Neonatal Intensive Care UnitStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lebanese University
- Responsible party
- Principal investigator, Lama Charafeddine, American University of Beirut Medical Center
- Investigators
- Lama Charafeddine, MD FAAP, Principal investigator, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03004482
- Sponsor's protocol ID
- PED.LC.06
- Status last verified
- Feb 2022
- First submitted
- 20 Dec 2016
- Last updated
- 17 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Aarts LA, Jeanne V, Cleary JP, Lieber C, Nelson JS, Bambang Oetomo S, Verkruysse W. Non-contact heart rate monitoring utilizing camera photoplethysmography in the neonatal intensive care unit - a pilot study. Early Hum Dev. 2013 Dec;89(12):943-8. doi: 10.1016/j.earlhumdev.2013.09.016. Epub 2013 Oct 14.
PubMed 24135159H.-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.
Edmond K, Zaidi A. New approaches to preventing, diagnosing, and treating neonatal sepsis. PLoS Med. 2010 Mar 9;7(3):e1000213. doi: 10.1371/journal.pmed.1000213.
PubMed 20231868Poh MZ, McDuff DJ, Picard RW. Non-contact, automated cardiac pulse measurements using video imaging and blind source separation. Opt Express. 2010 May 10;18(10):10762-74. doi: 10.1364/OE.18.010762.
PubMed 20588929Wynn JL, Wong HR. Pathophysiology and treatment of septic shock in neonates. Clin Perinatol. 2010 Jun;37(2):439-79. doi: 10.1016/j.clp.2010.04.002.
PubMed 20569817Heart 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. No abstract available.
PubMed 8598068Fairchild KD, Schelonka RL, Kaufman DA, Carlo WA, Kattwinkel J, Porcelli PJ, Navarrete CT, Bancalari E, Aschner JL, Walker MW, Perez JA, Palmer C, Lake DE, O'Shea TM, Moorman JR. Septicemia mortality reduction in neonates in a heart rate characteristics monitoring trial. Pediatr Res. 2013 Nov;74(5):570-5. doi: 10.1038/pr.2013.136. Epub 2013 Aug 13.
PubMed 23942558Moorman 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.
PubMed 21864846Sullivan 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.
PubMed 24412138K. 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.
Sztajzel J. Heart rate variability: a noninvasive electrocardiographic method to measure the autonomic nervous system. Swiss Med Wkly. 2004 Sep 4;134(35-36):514-22. doi: 10.4414/smw.2004.10321.
PubMed 15517504Kattwinkel 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. No abstract available.
PubMed 20956231Marodi L. Neonatal innate immunity to infectious agents. Infect Immun. 2006 Apr;74(4):1999-2006. doi: 10.1128/IAI.74.4.1999-2006.2006. No abstract available.
PubMed 16552028Liu L, Johnson HL, Cousens S, Perin J, Scott S, Lawn JE, Rudan I, Campbell H, Cibulskis R, Li M, Mathers C, Black RE; Child Health Epidemiology Reference Group of WHO and UNICEF. Global, regional, and national causes of child mortality: an updated systematic analysis for 2010 with time trends since 2000. Lancet. 2012 Jun 9;379(9832):2151-61. doi: 10.1016/S0140-6736(12)60560-1. Epub 2012 May 11.
PubMed 22579125Young Infants Clinical Signs Study Group. Clinical signs that predict severe illness in children under age 2 months: a multicentre study. Lancet. 2008 Jan 12;371(9607):135-42. doi: 10.1016/S0140-6736(08)60106-3.
PubMed 18191685
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Noninvasive Monitoring and Diagnosis of Physiologic Disturbances in Term and Preterm Newborns Using Video Analysis Techniques
- ClinicalTrials.gov ID
- NCT03004482
- Acronym / sponsor ID
- PED.LC.06
- Conditions
- Neonatal Intensive Care Unit
- Keywords
- NICU, Recorded video images, physiological disorders
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: lack of Funding
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- Lebanese University
- Study start
- Sep 2015
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Feb 2023 (estimated)
- First posted
- 29 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 hour to 4 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Term and preterm newborns hosted at the AUBMC Neonatal ICU.
Key inclusion criteria (1 listed)
- Babies admitted to the neonatal intensive care unit (NICU) at AUBMC.
Key exclusion criteria (1 listed)
- Babies with sepsis, respiratory distress, and congenital anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Adaptation of the Eulerian Video Magnification monitoring technique for diseased term and preterm neonates.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2022.
- Background: PubMed 24135159Aarts LA, Jeanne V, Cleary JP, Lieber C, Nelson JS, Bambang Oetomo S, Verkruysse W. Non-contact heart rate monitoring utilizing camera photoplethysmography in the neonatal intensive care unit - a pilot study. Early Hum Dev. 2013 Dec;89(12):943-8. doi: 10.1016/j.earlhumdev.2013.09.016. Epub 2013 Oct 14.
- BackgroundH.-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.
- Background: PubMed 20231868Edmond K, Zaidi A. New approaches to preventing, diagnosing, and treating neonatal sepsis. PLoS Med. 2010 Mar 9;7(3):e1000213. doi: 10.1371/journal.pmed.1000213.
- Background: PubMed 20588929Poh MZ, McDuff DJ, Picard RW. Non-contact, automated cardiac pulse measurements using video imaging and blind source separation. Opt Express. 2010 May 10;18(10):10762-74. doi: 10.1364/OE.18.010762.
- Background: PubMed 20569817Wynn JL, Wong HR. Pathophysiology and treatment of septic shock in neonates. Clin Perinatol. 2010 Jun;37(2):439-79. doi: 10.1016/j.clp.2010.04.002.
- Background: PubMed 8598068Heart 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. No abstract available.
- Background: PubMed 23942558Fairchild KD, Schelonka RL, Kaufman DA, Carlo WA, Kattwinkel J, Porcelli PJ, Navarrete CT, Bancalari E, Aschner JL, Walker MW, Perez JA, Palmer C, Lake DE, O'Shea TM, Moorman JR. Septicemia mortality reduction in neonates in a heart rate characteristics monitoring trial. Pediatr Res. 2013 Nov;74(5):570-5. doi: 10.1038/pr.2013.136. Epub 2013 Aug 13.
- Background: PubMed 21864846Moorman 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.
- Background: PubMed 24412138Sullivan 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.
- BackgroundK. 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.
- Background: PubMed 15517504Sztajzel J. Heart rate variability: a noninvasive electrocardiographic method to measure the autonomic nervous system. Swiss Med Wkly. 2004 Sep 4;134(35-36):514-22. doi: 10.4414/smw.2004.10321.
- Background: PubMed 20956231Kattwinkel 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. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Neonatal Intensive Care Unit
Recruiting
NIRS Monitoring in the NICU and AKI
Acute Kidney Injury (AKI), Postnatal AKI
Not yet recruitingObservational study
Neonatal Thrombocytopenia in the NICU
Thrombocytopenia, Neonatal Thrombocytopenia
Not yet recruiting
Parent-Facilitated Early Oral-Sensory Experience in the NICU for Feeding Outcomes
Premature Birth, Infant, Premature
RecruitingObservational study
NICU Design: Open Space Versus Single Family Room
NICU Design
Enrolling by invitation
Neonatal Intensive Care Unit (NICU) Diaper Dermatitis: Prevention and Treatment With Airtime
Diaper Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lama Charafeddine, MD FAAP principal investigator
American University of Beirut Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal Intensive Care Unit, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 17 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adaptation of the Eulerian Video Magnification monitoring technique for healthy term and preterm neonates. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03004482, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2022.