Multimodal Monitoring of Hemodynamics in Extremely Low Birth Weight Preterm Infant in a Canadian Tertiary Level Unit

Summary

Low blood pressure is a common problem in the premature newborn and can affect over 30% of all Extremely Low Gestational Age Neonates (ELGAN) babies delivered less than 28 weeks completed. Neonatal clinicians assess the hemodynamic status of the infant using clinical signs and physiological parameters including heart rate, blood pressure, capillary refill time, urine output and laboratory parameters (base deficit and lactate). While urine output and laboratory parameters do not provide real-time assessment of the hemodynamic status, heart rate and capillary refill time could be non-specific, inaccurate and observer-dependent, respectively. Blood pressure (BP) continues to be used as a common physiological marker for cardiovascular state in neonates.However, there is increasing amount of evidence that monitoring blood pressure alone is not enough to ensure adequate systemic and cerebral perfusion and oxygenation. Indeed, preterm babies may have "low blood pressure" triggering pharmacological treatment while still maintaining adequate systemic flow- especially cerebral and other organ perfusion as shown by other noninvasive measures like targeted neonatal echocardiography (TNE) and near infrared spectroscopy (NIRS).

Using mean BP alone as the indication of treatment of neonatal cardiovascular compromise without taking into consideration the status of tissue perfusion may lead to unnecessary exposure of neonates to vasoactive medication. This medication can be potentially harmful to these extremely vulnerable patients. Analysis of a large neonatal database has demonstrated that treatment of hypotension was associated with an increase in serious brain injury. This held true even after the blood pressure was included in the regression mode, suggesting that it is treatment of hypotension, rather than the presence of hypotension which is harmful. The common interventions, fluid boluses followed by inotropes, could as well be harmful. Observational data has shown an association of fluid boluses with intracranial bleeding and in animal models intraventricular haemorrhage after hypotension can be induced by rapid volume infusion. Fluctuations in blood pressure when inotropes are introduced are well known and could also trigger haemorrhage.

Current standard approaches to evaluation and treatment of transitional circulatory problems in the preterm infant may be harmful. Therefore it is essential that these approaches are adequately investigated. This research study is trying to find out if having a detailed hemodynamic understanding using a multimodal assessment consisting of Targeted Neonatal Echocardiogram, Cerebral NIRS and clinical-biochemical data, will result in less inotrope use in ELGAN population during the first 72hours of transitional period.

Conditions

• Hemodynamic Instability

Interventions

OTHER

Hemodynamic report

The multimodal data comprising the clinical, biochemical, NIRS data and TNE where available will be used by the study team in such cases to reach a description of the hemodynamic status of the study infant and will be provided to the Clinical team.

Sponsors & Collaborators

• University of Alberta

  lead OTHER

Principal Investigators

• Kumar Kumaran · University of Alberta

• Po-Yin Cheung · University of Alberta

• Matthew Hicks · University of Alberta

• Abbas Hyderi · University of Alberta

• Renjini Lalitha Kumari · University of Alberta

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

23 Weeks

Max Age

28 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-15

Primary Completion

2022-03-30

Completion

2022-03-30

Countries

• Canada

Study Locations