Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

Blood Pressure Clinical Trial

— NICCOM  

Official title:

Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04064177
• Other study ID #: 19QC5170
• Status: Recruiting
• Start date: October 24, 2019
• Est. completion date: September 30, 2022

Study information

• Verified date: November 2019
• Source: Imperial College Healthcare NHS Trust
• Contact: Jayanta Banerjee Imperial College Healthcare NHS Trust
• Phone: 02033137308
• Email: jayanta.banerjee[@]nhs.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: September 30, 2022
• Est. primary completion date: September 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 40 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• Cardiac Output, High
• Cardiac Output, Low

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Imperial College Healthcare NHS Trust	London

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College Healthcare NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Changes in cardiac output	Changes in cardiac output (CO) measurement (mls/kg/min) in relation to neonatal intervention	36 months
Secondary	Changes in clinical outcome - Survival at discharge	Survival at discharge	36 months