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NCT Number: NCT04064177

Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

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.

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Key information

Age range

1 hour–40 week

Sex eligibility

All sexes

Study type

Observational

Primary location

Imperial College Healthcare NHS Trust

London, United Kingdom

Location status: Recruiting

Location contact

Becky Ward

CONTACT

[email protected]

About this study

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:

  • Can robust normal ranges of CO be constructed for neonates undergoing cardiovascular measurement?
  • How do neonatal interventions (fluid boluses, ventilation and inotropes) affect CO?
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NICAS cardiac output monitor

Device

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

Primary outcomes

  1. Haemodynamic outcome comparison to echocardiography measured CO

    Time frame: 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)

  2. Changes in cardiac output

    Time frame: 36 months

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

Secondary outcomes

  1. Changes in clinical outcome - Survival at discharge

    Time frame: 36 months

    Survival at discharge

Study contacts

Contact information is provided by the study sponsor or research team.

Jayanta Banerjee Imperial College Healthcare NHS Trust

CONTACT

[email protected]

02033137308

Sundar Sathiyamurthy Imperial College Healthcare NHS Trust

CONTACT

[email protected]

02033137308

Sponsors and collaborators

Lead sponsor

Imperial College Healthcare NHS Trust

Other

Registry information

Acronym: NICCOM

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Aug 21, 2019
Registry last updated
Jul 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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