NCT04064177

Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 148 (estimated)
• Sponsor: Imperial College Healthcare NHS Trust · Academic / Other
• Sex: All
• Age: 1 Hour – 40 Weeks
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	NICAS cardiac output monitor	Non-invasive continuous cardiac output monitoring device using total body bioimpedance.

Timeline

• Start date: 2019-10-24
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2019-08-21
• Last updated: 2024-07-29

Locations

1 site across 1 country: United Kingdom