Imperial College Healthcare NHS Trust
London, United Kingdom
Location status: Recruiting
NCT Number: NCT04064177
This is an observational study in newborn term and preterm infants. The study will validate if non-invasive continuous cardiac output monitoring is feasible in newborn infants, if normative values can be constructed and what is the effect of fluid boluses and inotropes on cardiac output and peripheral vascular resistance.
Interested in participating?
Request Info1 hour–40 week
All sexes
Observational
London, United Kingdom
Location status: Recruiting
This is a 3-year prospective observational study.
Principal research question:
Is non-invasive continuous cardiac output (CO) measurement a validated tool of comprehensive cardiovascular assessment in neonatal intensive care (NICU)?
Secondary research questions:
A prospective study of stable newborn babies in the postnatal ward and sick term and preterm infants in the NICU in 36 months.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Non-invasive continuous cardiac output monitoring device using total body bioimpedance.
Time frame: 36 months
Non-invasive continuous Cardiac Output (CO) measurement (mls/kg/min) during the first month of life in comparison to echocardiography measured CO (mls/kg/min)
Time frame: 36 months
Changes in cardiac output (CO) measurement (mls/kg/min) in relation to neonatal intervention
Time frame: 36 months
Survival at discharge
Contact information is provided by the study sponsor or research team.
Jayanta Banerjee Imperial College Healthcare NHS Trust
CONTACT
Sundar Sathiyamurthy Imperial College Healthcare NHS Trust
CONTACT
Imperial College Healthcare NHS Trust
Other
Acronym: NICCOM
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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