Heart Rate Variability in Febrile Young Infants

NCT04103151 | Completed

• 1 other identifier: HRV-INFANTS-2017
• Study Type: observational
• Target: 330
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Number of patients with Serious Infections

  Serious infections are defined by: Sepsis, meningitis, lobar pneumonia, osteomyelitis, abscess, and urinary tract infection

  Within 2 weeks of hospitalisation

Study Arms (2)

Febrile infants

Febrile Infants less than 3 months presenting to the emergency department with a temperature of ≥ 38oC.

Device: Single lead ECG

Afebrile infants

Afebrile Infants less than 3 months presenting to the emergency department

Device: Single lead ECG

Interventions

Single lead ECG DEVICE

Heart Rate Variability will be monitored using a single lead electrocardiogram

Afebrile infants; Febrile infants

Eligibility Criteria

• Age: 1 Day - 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

330 infants \< 3 months presenting with fever. Fever is defined as an axillary or rectal temperature ≥ 38oC. 75 infants \< 3 months (clinically well) presenting without fever. These include young infants presenting for neonatal jaundice or other non-febrile conditions.

You may qualify if:

• Infants \< 3 months presenting to the ED will be included (both febrile and non-febrile) Febrile infants are those with an axillary or rectal temperature ≥ 38oC at triage and/or outside of the hospital. OR Non-febrile infants include those presenting to the ED for serum bilirubin checks or otherwise

You may not qualify if:

• Infants who are in active resuscitation for septic shock. Infants of parents who refused to give informed consent. Premature infants delivered at a gestation of \< 35 weeks.

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

KK Women's and Children' Hospital

Singapore, 229899, Singapore

Location

Related Publications (2)

• Choa ZX, Raveentheran G, Khoo ZX, Ong GY, Wong L, Piragasam R, Ganapathy S, Chong SL. Prevalence of serious bacterial infections and performance of inflammatory markers in febrile infants with and without proven viral illness. Emerg Med J. 2025 Oct 20;42(11):721-727. doi: 10.1136/emermed-2024-214435.

  PMID: 40335269 DERIVED

• Chong SL, Ong GY, Allen JC, Lee JH, Piragasam R, Koh GZX, Mahajan P, Liu N, Ong MEH. Early prediction of serious infections in febrile infants incorporating heart rate variability in an emergency department: a pilot study. Emerg Med J. 2021 Aug;38(8):607-612. doi: 10.1136/emermed-2020-210675. Epub 2021 Apr 16.

  PMID: 33863774 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2019
• First Posted: September 25, 2019
• Study Start: December 11, 2017
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)