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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04064177
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Cardiac Output, Low Cardiac Output, High Blood Pressure Device: NICAS cardiac output monitor

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.

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Study Type : Observational
Estimated Enrollment : 148 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study
Actual Study Start Date : October 24, 2019
Estimated Primary Completion Date : September 30, 2022
Estimated Study Completion Date : September 30, 2022

Group/Cohort Intervention/treatment
Babies (24-42 weeks)
All babies born between 24 and 42 weeks
Device: NICAS cardiac output monitor
Non-invasive continuous cardiac output monitoring device using total body bioimpedance.

Preterm infants
Preterm infants with fetal growth restriction
Device: NICAS cardiac output monitor
Non-invasive continuous cardiac output monitoring device using total body bioimpedance.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Changes in clinical outcome - Survival at discharge [ Time Frame: 36 months ]
    Survival at discharge



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 40 Weeks   (Child)
Sexes Eligible for Study:   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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064177


Contacts
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Contact: Jayanta Banerjee Imperial College Healthcare NHS Trust 02033137308 jayanta.banerjee@nhs.net
Contact: Sundar Sathiyamurthy Imperial College Healthcare NHS Trust 02033137308 s.sathiyamurthy@nhs.net

Locations
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United Kingdom
Imperial College Healthcare NHS Trust Recruiting
London, United Kingdom
Contact: Becky Ward       Becky.Ward@imperial.ac.uk   
Sponsors and Collaborators
Imperial College Healthcare NHS Trust
Investigators
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Principal Investigator: Jayanta Banerjee Neonatal consultant
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Responsible Party: Imperial College Healthcare NHS Trust
ClinicalTrials.gov Identifier: NCT04064177    
Other Study ID Numbers: 19QC5170
First Posted: August 21, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College Healthcare NHS Trust:
Blood Pressure
Additional relevant MeSH terms:
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Cardiac Output, Low
Cardiac Output, High
Heart Diseases
Cardiovascular Diseases
Signs and Symptoms