Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

NCT04064177 — Unknown, 148 participants, Imperial College Healthcare NHS Trust

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Registry	NCT04064177, acronym NICCOM
Status	Unknown
Study type	Observational
Enrollment	148 (Estimated)
Sponsor	Imperial College Healthcare NHS Trust (Other)
Conditions	Cardiac Output, Low, Cardiac Output, High, Blood Pressure
Interventions	NICAS cardiac output monitor (Device)
Dates	start 2019-10-24, primary completion 2024-12-31 (estimated), completion 2024-12-31 (estimated), first posted 2019-08-21, last updated 2024-07-29
Locations	1 site in United Kingdom

-Summary

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.

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+Detailed description

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:

1. Can robust normal ranges of CO be constructed for neonates undergoing cardiovascular measurement?
2. How do neonatal interventions (fluid boluses, ventilation and inotropes) affect CO?
3. Does the Non-invasive continuous cardiac output monitoring in children with foetal growth restriction (FGR) differ from normative CO data as above (1)?

A prospective study of stable newborn babies in the postnatal ward and sick term and preterm infants in the NICU in 36 months.

+Arms and interventions

Arm	Type	Interventions	Description
Babies (24-42 weeks)		Device: NICAS cardiac output monitor	All babies born between 24 and 42 weeks
Preterm infants		Device: NICAS cardiac output monitor	Preterm infants with fetal growth restriction

NICAS cardiac output monitor (Device): Non-invasive continuous cardiac output monitoring device using total body bioimpedance.

+Outcome measures

Primary outcomes

Haemodynamic outcome comparison to echocardiography measured CO [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)
Changes in cardiac output [36 months]: Changes in cardiac output (CO) measurement (mls/kg/min) in relation to neonatal intervention

Secondary outcomes

Changes in clinical outcome - Survival at discharge [36 months]: Survival at discharge

+Eligibility

Sex: All, ages: 1 Hour to 40 Weeks

Inclusion Criteria:

* Healthy term infants in postnatal ward (within the first 72 hours of age)
* Term and Preterm infants (including those with FGR) admitted to the neonatal unit
* Written informed parental consent (prospective for postnatal ward and retrospective for babies admitted to the neonatal units)

Exclusion Criteria:

* Antenatal or postnatal diagnosis of severe congenital anomaly
* Infants with no realistic chance of survival
* Infants who are >12 hours of age
* Infants with fragile skin not permitting skin probe placement

+Locations (1)

Facility	City	Country	Status
Imperial College Healthcare NHS Trust	London	United Kingdom	Recruiting

+Publications

Results publication: 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. PMID 38123965

+Investigators

Jayanta Banerjee, Principal investigator, Neonatal consultant