Cardiac Output, LowNICCOMNCT04064177
Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study
An observational study of Cardiac Output, Low and Cardiac Output, High, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 hour to 40 weeks
- Conditions the study is for
- Cardiac Output, Low, Cardiac Output, High, Blood Pressure
- What is being tested?
- NICAS cardiac output monitor
- Type of treatment
- Medical device
- How many people
- 148 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Oct 2019to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 hour to 40 weeks
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Sundar Sathiyamurthy Imperial College Healthcare NHS Trust contact
United Kingdom1 site, 1 recruiting
- Recruiting
Imperial College Healthcare NHS Trust
London
Becky Ward, Becky.Ward@imperial.ac.uk
About this 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.
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:
- 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.
- Conditions
- Cardiac Output, Low, Cardiac Output, High, Blood Pressure
- Being tested
- NICAS cardiac output monitor
- Keywords
- Blood Pressure
- Medical subject headings
- Cardiac Output, Low, Cardiac Output, High
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NICAS cardiac output monitorDevice
Non-invasive continuous cardiac output monitoring device using total body bioimpedance.
| Study group | Role | What they receive |
|---|---|---|
| Babies (24-42 weeks) | All babies born between 24 and 42 weeks Receives: Device: NICAS cardiac output monitor | |
| Preterm infants | Preterm infants with fetal growth restriction Receives: Device: NICAS cardiac output monitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 36 months
Changes in cardiac output
Changes in cardiac output (CO) measurement (mls/kg/min) in relation to neonatal intervention
Measured: 36 months
Secondary outcomes (1)
Changes in clinical outcome - Survival at discharge
Survival at discharge
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start24 Oct 2019
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiac Output, LowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jayanta Banerjee, Principal investigator, Neonatal consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04064177
- Sponsor's protocol ID
- 19QC5170
- Acronym
- NICCOM
- Status last verified
- Jul 2024
- First submitted
- 6 Aug 2019
- Last updated
- 29 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Banerjee J, Khatib N, Mansfield RC, Sathiyamurthy S, Kariholu U, Lees C. Continuous non-invasive measurement of cardiac output in neonatal intensive care using regional impedance cardiography: a prospective observational study. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):450-455. doi: 10.1136/archdischild-2023-325941.
PubMed 38123965
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study
- ClinicalTrials.gov ID
- NCT04064177
- Acronym / sponsor ID
- NICCOM / 19QC5170
- Conditions
- Cardiac Output, Low, Cardiac Output, High, Blood Pressure
- Keywords
- Blood Pressure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 24 Oct 2019 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 21 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Babies (24-42 weeks) | – | Device: NICAS cardiac output monitorAll babies born between 24 and 42 weeks |
| Preterm infants | – | Device: NICAS cardiac output monitorPreterm infants with fetal growth restriction |
Who may qualify
- Ages
- 1 hour to 40 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NICAS cardiac output monitorNon-invasive continuous cardiac output monitoring device using total body bioimpedance. | Device | Babies (24-42 weeks), Preterm infants |
Primary outcome
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)
Changes in cardiac output
Time frame: 36 months
Changes in cardiac output (CO) measurement (mls/kg/min) in relation to neonatal intervention
1 secondary outcome
Changes in clinical outcome - Survival at discharge
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2024.
- Derived from this study: PubMed 38123965Banerjee J, Khatib N, Mansfield RC, Sathiyamurthy S, Kariholu U, Lees C. Continuous non-invasive measurement of cardiac output in neonatal intensive care using regional impedance cardiography: a prospective observational study. Arch Dis Child Fetal Neonatal Ed. 2024 Jun 19;109(4):450-455. doi: 10.1136/archdischild-2023-325941.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sundar Sathiyamurthy Imperial College Healthcare NHS Trust contact
Jayanta Banerjee principal investigator
Neonatal consultant
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Output, Low and Cardiac Output, High, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jayanta Banerjee Imperial College Healthcare NHS Trust (02033137308, jayanta.banerjee@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Haemodynamic outcome comparison to echocardiography measured CO (time frame: 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04064177, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2024.