Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study (NICCOM)

Imperial College Healthcare NHS Trust

Status: Enrolling

Conditions: Cardiac Output, Low; Blood Pressure; Cardiac Output, High

Treatments: Device: NICAS cardiac output monitor

Study type: Observational

Funder types: Other

Identifiers

NCT04064177

19QC5170

Details and patient eligibility

About

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.

Full 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.

Enrollment: 148 estimated patients

Sex: All

Ages: 1 hour to 40 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

148 participants in 2 patient groups

Babies (24-42 weeks)

Description:

All babies born between 24 and 42 weeks

Treatment:

Device: NICAS cardiac output monitor

Preterm infants

Description:

Preterm infants with fetal growth restriction

Treatment:

Device: NICAS cardiac output monitor