Non-invasive Continuous Cardiac Output Monitoring in Preterm Infants Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

148 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-24

Study Completion Date

2024-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Cardiac Output, Low Cardiac Output, High Blood Pressure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Babies (24-42 weeks)

All babies born between 24 and 42 weeks

NICAS cardiac output monitor

Intervention Type DEVICE

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

Preterm infants

Preterm infants with fetal growth restriction

NICAS cardiac output monitor

Intervention Type DEVICE

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

Interventions

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NICAS cardiac output monitor

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

1 Hour

Maximum Eligible Age

40 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No