Clinical trial NCT00307333: Impact of Heart Rate Characteristics Monitoring in Neonates
Official title: Impact of Heart Rate Characteristics Monitoring in Neonates
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sepsis
Keywords: very low birth weight infants
heart rate characteristics
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Medical Predictive Science Corporation
First posted: 2006-03-27
Enrollment: 3003
Sex: ALL
Minimum age (years): 1
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Hypothesis: Fewer neonates managed using information from heart rate characteristics (HRC) will require intubation and mechanical ventilation as a result of sepsis and sepsis-like illness.

Infants will be randomly assigned to one of two groups. One group of infants will have the HRC index known to the physicians caring for them, and physicians will use the HRC index as they desire to aid in clinical management.

Infants in the other group will have the HRC index recorded, but this information will not be displayed to the physicians caring for the infants.

Detailed description: Following randomization, infants will be managed as usual practice. The treating physicians of the HRC-display group will be able to utilize the HRC score to assist in the care of the infant. The physicians of the no-display group will provide care as per standard.

Clinical symptoms will be treated according to the medical discretion of each physician. Cultures will be obtained and antibiotics administered as per the medical discretion of the physicians.

Clinical, culture results, antibiotic administration, ventilator use, and outcome at 120 days data will be collected on the infants as well as their HRC score calculated by the HeRO heart rate characteristics monitor.

Eligibility criteria: Inclusion Criteria:

* Infants admitted to NICU
* Birth weight \< 1500 grams
* Gestational age \< or = 32 weeks
* Informed consent obtained from parent

Exclusion Criteria:

* Evidence of sustained cardiac arrhythmia
* Use of an electronic pacemaker

Primary outcomes:
measure: Number of Ventilator-free Days
timeFrame: 120 days
Secondary outcomes:
measure: Duration of Hospital Stay
timeFrame: 120 days
measure: Days on Antibiotics
timeFrame: 120 days
measure: Mortality
timeFrame: 120 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Orlando
country: United States
facility: Winnie Plamer Hospital for Women and Babies
state: Florida
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Hershey
country: United States
facility: Milton S. Hershey Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Greenville Hospital System
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt Children's Hospital
state: Tennessee
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia
name: Joseph R Moorman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: King WE, Carlo WA, O'Shea TM, Schelonka RL; HRC neurodevelopmental follow-up investigators. Multivariable Predictive Models of Death or Neurodevelopmental Impairment Among Extremely Low Birth Weight Infants Using Heart Rate Characteristics. J Pediatr. 2022 Mar;242:137-144.e4. doi: 10.1016/j.jpeds.2021.11.026. Epub 2021 Nov 17.
citation: King WE, Carlo WA, O'Shea TM, Schelonka RL; HRC neurodevelopmental follow-up investigators. Heart rate characteristics monitoring and reduction in mortality or neurodevelopmental impairment in extremely low birthweight infants with sepsis. Early Hum Dev. 2021 Aug;159:105419. doi: 10.1016/j.earlhumdev.2021.105419. Epub 2021 Jul 4.
citation: Swanson JR, King WE, Sinkin RA, Lake DE, Carlo WA, Schelonka RL, Porcelli PJ, Navarrete CT, Bancalari E, Aschner JL, Perez JA, O'Shea TM, Walker MW. Neonatal Intensive Care Unit Length of Stay Reduction by Heart Rate Characteristics Monitoring. J Pediatr. 2018 Jul;198:162-167. doi: 10.1016/j.jpeds.2018.02.045. Epub 2018 Apr 24.
citation: Sullivan BA, Grice SM, Lake DE, Moorman JR, Fairchild KD. Infection and other clinical correlates of abnormal heart rate characteristics in preterm infants. J Pediatr. 2014 Apr;164(4):775-80. doi: 10.1016/j.jpeds.2013.11.038. Epub 2014 Jan 10.
citation: Moorman JR, Carlo WA, Kattwinkel J, Schelonka RL, Porcelli PJ, Navarrete CT, Bancalari E, Aschner JL, Whit Walker M, Perez JA, Palmer C, Stukenborg GJ, Lake DE, Michael O'Shea T. Mortality reduction by heart rate characteristic monitoring in very low birth weight neonates: a randomized trial. J Pediatr. 2011 Dec;159(6):900-6.e1. doi: 10.1016/j.jpeds.2011.06.044. Epub 2011 Aug 24.