Health TrialsbyHealthPanel

Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

ConditionsCardiac Output, LowCardiac Output, HighBlood Pressure
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-40
SponsorImperial College Healthcare NHS Trust

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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 population

All term and preterm infants (24-42 weeks of gestational age) for the validation study and preterm infants with fetal growth restriction for the longitudinal study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • NICAS cardiac output monitor

    Device

    Non-invasive continuous cardiac output monitoring device using total body bioimpedance.

Treatment groups

148 Participants
are divided into 2 treatment groups
Group A: Babies (24-42 weeks)1 intervention
Group B: Preterm infants1 intervention

Trial outcomes

Primary outcomes

1

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)

Time frame
36 months
2

Changes in cardiac output

Changes in cardiac output (CO) measurement (mls/kg/min) in relation to neonatal intervention

Time frame
36 months

Secondary outcomes

1

Changes in clinical outcome - Survival at discharge

Survival at discharge

Time frame
36 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College Healthcare NHS Trust

Lead sponsor

Source ClinicalTrials.gov
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