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Heart Rate Variability in Febrile Young Infants

NCT04103151 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2024-03-06

No results posted yet for this study

Summary

Febrile infants younger than 3 months old present a diagnostic dilemma to the emergency physician. Tension remains between the need for early aggressive intervention among patients with suspected sepsis and the global phenomena of increasing antibiotic resistance.

The investigators aim to: (1) To study the association between heart rate variability (HRV) and the presence of a serious infection (SI) among infants younger than 3 months old. The investigators hypothesize that a reduced HRV is associated with the presence of SI. (2) To compare HRV between febrile infants \< 3 months with non-febrile infants. The investigators hypothesize that the variability will be reduced in febrile infants with SIs when compared to non-febrile well infants, but not among febrile infants without SIs when compared to non-febrile well infants. (3) To study if HRV will provide incremental diagnostic information over current triage tools.

Conditions

  • Heart Rate
  • Variability
  • Triage
  • Decision Support Techniques

Interventions

DEVICE

Single lead ECG

Heart Rate Variability will be monitored using a single lead electrocardiogram

Sponsors & Collaborators

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Eligibility

Min Age
1 Day
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-11
Primary Completion
2021-12-31
Completion
2023-12-31

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04103151 on ClinicalTrials.gov