Heart Rate Clinical Trial
— HRVOfficial title:
Rapid Triage for Serious Infections in Infants Younger Than 3 Months Using A Novel Heart Rate Variability Tool
Verified date | March 2024 |
Source | KK Women's and Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 330 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Day to 3 Months |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Singapore | KK Women's and Children' Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
KK Women's and Children's Hospital | National Medical Research Council (NMRC), Singapore |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03832205 -
Validation of Respiratory Rate and Heart Rate Measurements by Capaciflectors Placed in Four Locations on the Chest
|
||
Completed |
NCT03723954 -
Heart Rate Variations of Golf Fans During the 2018 the Ryder Cup
|
||
Withdrawn |
NCT01026961 -
Safety of Phenylephrine Hydrochloride, Acetaminophen, Dimethindene Maleate Compared to Phenylephrine Hydrochloride Alone in Healthy Volunteers
|
Phase 1/Phase 2 | |
Completed |
NCT00760253 -
Compare the Side Effects and Difference Awake Level of Three TCI Propofol Formula in TVOR Patients
|
N/A | |
Completed |
NCT00380341 -
Effects of Instrument-Applied Spinal Manipulative Therapy on Postureal Control and Autonomic Balance
|
N/A | |
Completed |
NCT04179279 -
Comparative Analysis of a Non-contact Respiratory and Heart Rate Monitor Vs. a Conventional Clinically Validated Reference Monitor
|
||
Completed |
NCT02469844 -
Heart Rate Variability (HRV) Analysis in Patients With Nocturnal Epileptic Seizures
|
||
Not yet recruiting |
NCT00503282 -
Urinary Catheter Exchange on Admission of Septic Elderly With Permanent Catheter Before Initiation of Antibiotics
|
N/A | |
Completed |
NCT05160207 -
Intubation-induced Decrease in Heart Rate as an Indicator for Intraoperative Bradycardia
|
||
Completed |
NCT02997800 -
The Effect of Intraoperative Labetalol on Time to Discharge
|
Phase 2 | |
Withdrawn |
NCT01701960 -
Effect of Local Anesthetic on Hemodynamic Measures During Nasal Surgery
|
N/A | |
Completed |
NCT03359928 -
Acute Physiological and Perceptual Responses to Novel Forms of High-intensity Interval Exercise
|
N/A | |
Completed |
NCT05600725 -
Novel Cardiac Pacing to Initiate Cardiac Remodeling in Heart Failure
|
N/A | |
Completed |
NCT05366049 -
The Effect of Methods Used in Oral Antipyretic Administration on the Vital Findings of the Child With Fever
|
N/A | |
Recruiting |
NCT05401435 -
Reliability of Measuring Blood Pressure With a Smartwatch
|
N/A | |
Completed |
NCT01638169 -
The Contribution of Heels for Walking Quality Among Children With Muscular Dystrophy
|
N/A | |
Completed |
NCT00143988 -
Heart Rate and Blood Pressure Response During Exercise and Sexual Activity in Normotensive and Hypertensive Volunteers
|
N/A | |
Completed |
NCT03131375 -
Dexmedetomidine Reduces Emergence Delirium in Children Undergoing Tonsillectomy With Propofol Anesthesia
|
Phase 2/Phase 3 | |
Completed |
NCT01612130 -
Valerian for Conscious Sedation in Patients Submitted to Impacted Lower Third Molars Surgery
|
N/A | |
Completed |
NCT06095635 -
Acute Influence of Resveratrol Supplementation and Beet Extract in Recovery After Exercise in Coronary Paths
|
N/A |