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RecruitingNCT04064177NICCOMUpdated Jul 29, 2024

Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

An observational study in Cardiac Output, Low, Cardiac Output, High and Blood Pressure, sponsored by Imperial College Healthcare NHS Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 1 Hour to 40 Weeks. Per ClinicalTrials.gov, last updated 2024-07-29.

Sponsored by Imperial College Healthcare NHS Trust · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 9 months ago, but the record still lists the study as recruiting.
  • Started Oct 2019; still recruiting 6 years 11 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
148
Ages
1 Hour to 40 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

Keywords

  • Blood Pressure
03

In context

Cardiac Output, Low

94 studies on the registry are indexed under Cardiac Output, Low; 15 are open to participants now.

This study's planned enrollment of 148 is above the median of 60 across 45 observational studies indexed under Cardiac Output, Low.

Browse Cardiac Output, Low studies →

Lead sponsor

Imperial College Healthcare NHS Trust is the lead sponsor of 79 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Hour to 40 Weeks
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study 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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
148 participants (estimated)
Patient registry
No

Groups and cohorts

  • Babies (24-42 weeks)

    All babies born between 24 and 42 weeks

    Device: NICAS cardiac output monitor

  • Preterm infants

    Preterm infants with fetal growth restriction

    Device: NICAS cardiac output monitor

Interventions

  • DeviceNICAS cardiac output monitor

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

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04064177
Lead sponsor
Imperial College Healthcare NHS Trust
Responsible party
Sponsor
First posted
Aug 21, 2019
Start date
Oct 24, 2019
Primary completion
Dec 31, 2024 (estimated)
Completion
Dec 31, 2024 (estimated)
Last update
Jul 29, 2024

Study contacts

Jayanta Banerjee Imperial College Healthcare NHS Trust
Contact
jayanta.banerjee@nhs.net
02033137308
Sundar Sathiyamurthy Imperial College Healthcare NHS Trust
Contact
s.sathiyamurthy@nhs.net
02033137308
Jayanta Banerjee
principal investigator · Neonatal consultant

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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