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

NCT03841929 | Completed DMC

• 1 other identifier: Pro00084238
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Multimodal hemodynamic assessment

Outcome Measures

Primary Outcomes (2)

• Peak and Mean Vasoactive-Ventilation-Renal scores in both groups

  Higher the scores, higher the cardiovascular support

  at 7 days of life

• Peak and Mean Vasoactive Inotrope scores in both groups

  Higher the scores, higher the cardiovascular support

  at 7days of life

Secondary Outcomes (8)

• Duration of mechanical ventilation

  through study completion, an average of 44 weeks corrected gestation

• Total number of Days in the hospital

  through study completion, an average of 44 weeks corrected gestation

• Number of Participants with Chronic Lung Disease

  through study completion, an average of 44 weeks corrected gestation

• Number of Participants with Necrotizing Enterocolitis

  through study completion, an average of 44 weeks corrected gestation

• Number of Participants with Retinopathy Of Prematurity

  through study completion, an average of 44 weeks corrected gestation

Study Arms (2)

Study Arm

EXPERIMENTAL

ELGANs recruited to the study group in addition to standard of care will have continuous cerebral NIRS monitoring for the initial 72 hours and TNE studies at definitive time frames and a hemodynamic report will be provided to the clinical team using the results of the multimodal monitoring and clinical data. The report will be a description of the hemodynamic status without any suggestions for management.

Other: Hemodynamic report

Standard Arm

NO INTERVENTION

ELGANs recruited into Standard arm will have the standard monitoring including cardiorespiratory monitoring. The invasive blood pressure monitoring, NIRS and TNE monitoring as per the clinical team's discretion - consistent with the current standard of care. No hemodynamic report will be provided routinely.

Interventions

Hemodynamic report OTHER

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.

Study Arm

Eligibility Criteria

• Age: 23 Weeks - 28 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm babies less than 29 weeks (ELGAN)
• Babies born in Royal Alexandra Hospital(RAH) and admitted to RAH-NICU for first 7days of life

You may not qualify if:

• Structural heart diseases
• Major congenital disorder or chromosomal disorder

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

Royal Alexandra Hospital-NICU

Edmonton, Alberta, Canada

Location

Related Publications (1)

• Lalitha R, Bitar E, Hicks M, Surak A, Hyderi A, Pepper D, Cheung PY, Kumaran K. Multimodal Monitoring of Hemodynamics in Neonates With Extremely Low Gestational Age: A Randomized Clinical Trial. JAMA Netw Open. 2025 Apr 1;8(4):e254101. doi: 10.1001/jamanetworkopen.2025.4101.

  PMID: 40202760 DERIVED

Study Officials

• Kumar Kumaran

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Po-Yin Cheung

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Matthew Hicks

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Abbas Hyderi

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Renjini Lalitha Kumari

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor, University of Alberta,

Study Record Dates

• First Submitted: February 5, 2019
• First Posted: February 15, 2019
• Study Start: February 15, 2019
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: May 19, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)