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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Babies (24-42 weeks) | All babies born between 24 and 42 weeks |
| |
| Preterm infants | Preterm infants with fetal growth restriction |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NICAS cardiac output monitor | Device | Non-invasive continuous cardiac output monitoring device using total body bioimpedance. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Haemodynamic outcome comparison to echocardiography measured CO | 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) | 36 months |
| Changes in cardiac output | Changes in cardiac output (CO) measurement (mls/kg/min) in relation to neonatal intervention | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in clinical outcome - Survival at discharge | Survival at discharge | 36 months |
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Inclusion Criteria:
Exclusion Criteria:
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All term and preterm infants (24-42 weeks of gestational age) for the validation study and preterm infants with fetal growth restriction for the longitudinal study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jayanta Banerjee Imperial College Healthcare NHS Trust | Contact | 02033137308 | jayanta.banerjee@nhs.net | |
| Sundar Sathiyamurthy Imperial College Healthcare NHS Trust | Contact | 02033137308 | s.sathiyamurthy@nhs.net |
| Name | Affiliation | Role |
|---|---|---|
| Jayanta Banerjee | Neonatal consultant | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imperial College Healthcare NHS Trust | Recruiting | London | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38123965 | Derived | Banerjee J, Khatib N, Mansfield RC, Sathiyamurthy S, Kariholu U, Lees C. Continuous non-invasive measurement of cardiac output in neonatal intensive care using regional impedance cardiography: a prospective observational study. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):450-455. doi: 10.1136/archdischild-2023-325941. |
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| ID | Term |
|---|---|
| D002303 | Cardiac Output, Low |
| D016534 | Cardiac Output, High |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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