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Heart Rate Variability in Febrile Young Infants (HRV)

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ClinicalTrials.gov Identifier: NCT04103151
Recruitment Status : Recruiting
First Posted : September 25, 2019
Last Update Posted : February 21, 2021
Sponsor:
Collaborator:
National Medical Research Council (NMRC), Singapore
Information provided by (Responsible Party):
KK Women's and Children's Hospital

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.


Condition or disease Intervention/treatment
Heart Rate Variability Triage Decision Support Techniques Device: Single lead ECG

Detailed Description:

Febrile young infants younger than 3 months old present a diagnostic dilemma to the pediatric emergency department (ED) physician. The potential for a missed serious infection (SI) poses the threat of premature death and long-term disability among these infants. Despite decreasing early-onset neonatal sepsis rates due to obstetric prevention strategies, high rates of hospitalization and administration of parenteral antibiotics occur in this age group. Continual tension remains between the need for early and aggressive intervention among patients suspected with sepsis and the global phenomena of increasing antibiotic resistance. Research networks have attempted to build diagnostic algorithms to guide the identification of these ill infants. These are often useful as adjuncts to the clinician's gestalt, but generalizability remains questionable.

Vital signs are of paramount importance in recognizing ill children and have been used in pediatric early warning system scores (PEWS) and various triage systems. Vital signs have resurfaced as the focus of research in recent years, with various groups purposing to update evidence-based normal heart rate ranges among children. Normative heart rate ranges are infamously difficult to define due to the hemodynamic lability in these young infants, multiple confounders for abnormal heart rate, and the variable physiological response during acute stress states.

Previous pilot data showed that the Advanced Paediatric Life Support (APLS) and Fleming (<10th or >90th centile) guidelines performed with the highest sensitivity (66.0% and 62.6%, respectively) and the highest Negative Predictive Value (NPV) (73.3% and 71.4%, respectively). No single guideline reached a sensitivity of greater than 70%.

Objectives and Hypothesis

  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.

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Study Type : Observational
Estimated Enrollment : 330 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Rapid Triage for Serious Infections in Infants Younger Than 3 Months Using A Novel Heart Rate Variability Tool
Actual Study Start Date : December 11, 2017
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever

Group/Cohort Intervention/treatment
Febrile infants
Febrile Infants less than 3 months presenting to the emergency department with a temperature of ≥ 38oC.
Device: Single lead ECG
Heart Rate Variability will be monitored using a single lead electrocardiogram

Afebrile infants
Afebrile Infants less than 3 months presenting to the emergency department
Device: Single lead ECG
Heart Rate Variability will be monitored using a single lead electrocardiogram




Primary Outcome Measures :
  1. Number of patients with Serious Infections [ Time Frame: Within 2 weeks of hospitalisation ]
    Serious infections are defined by: Sepsis, meningitis, lobar pneumonia, osteomyelitis, abscess, and urinary tract infection



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04103151


Locations
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Singapore
KK Women's and Children' Hospital Recruiting
Singapore, Singapore, 229899
Contact: Shu-Ling Chong, MBBS, MRCPCH, MCI, MPH    65-63941179    Chong.Shu-Ling@kkh.com.sg   
Sponsors and Collaborators
KK Women's and Children's Hospital
National Medical Research Council (NMRC), Singapore
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: KK Women's and Children's Hospital
ClinicalTrials.gov Identifier: NCT04103151    
Other Study ID Numbers: HRV-INFANTS-2017
First Posted: September 25, 2019    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual participant data will be shared with current study team. Sharing of de-identified data with collaborators will be reviewed by the study team.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No