Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

Recruiting

• Conditions: Cardiac Output, High; Cardiac Output, Low; Blood Pressure
• Interventions: Device: NICAS cardiac output monitor

• Registration Number: NCT04064177
• Lead Sponsor: Imperial College Healthcare NHS Trust

Brief 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.

Study Timeline

• Study First Submitted: 2019-08-06
• Study First Submitted QC: 2019-08-20
• Study First Posted: 2019-08-21
• Study Start: 2019-10-24
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-26
• Last Update Posted: 2024-07-29
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 148

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Babies (24-42 weeks)	NICAS cardiac output monitor	All babies born between 24 and 42 weeks
Preterm infants	NICAS cardiac output monitor	Preterm infants with fetal growth restriction

Primary Outcome Measures

Name	Time	Method
Changes in cardiac output	36 months	Changes in cardiac output (CO) measurement (mls/kg/min) in relation to neonatal intervention
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)

Secondary Outcome Measures

Name	Time	Method
Changes in clinical outcome - Survival at discharge	36 months	Survival at discharge

Trial Locations

Locations (1)

Imperial College Healthcare NHS Trust; 🇬🇧 London, United Kingdom