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

November 21, 2019 updated by: Imperial College Healthcare NHS Trust
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

148

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 hour to 9 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
36 months
Changes in cardiac output
Time Frame: 36 months
Changes in cardiac output (CO) measurement (mls/kg/min) in relation to neonatal intervention
36 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in clinical outcome - Survival at discharge
Time Frame: 36 months
Survival at discharge
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College Healthcare NHS Trust

Investigators

  • Principal Investigator: Jayanta Banerjee, Neonatal consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 24, 2019

Primary Completion (ANTICIPATED)

September 30, 2022

Study Completion (ANTICIPATED)

September 30, 2022

Study Registration Dates

First Submitted

August 6, 2019

First Submitted That Met QC Criteria

August 20, 2019

First Posted (ACTUAL)

August 21, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 25, 2019

Last Update Submitted That Met QC Criteria

November 21, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19QC5170

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Blood Pressure

Clinical Trials on NICAS cardiac output monitor

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Saint Lucia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe