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Trial · NCT00307333

Impact of Heart Rate Characteristics Monitoring in Neonates

NCT00307333, Not applicable, Completed, University of Virginia; results first posted 2013-05-17

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Impact of Heart Rate Characteristics Monitoring in Neonates. Trials, record NCT00307333. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00307333

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Impact of Heart Rate Characteristics Monitoring in Neonates
NCT number
NCT00307333
Status
Completed
Phases
Not applicable
Enrollment
3,003 participants, actual
Lead sponsor
University of Virginia
Conditions
Sepsis
Interventions
HeRO heart rate characteristics monitor
First posted
2006-03-27
Last updated
2013-05-27
Results first posted
2013-05-17

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryNumber of Ventilator-free Days120 days
SecondaryDuration of Hospital Stay120 days
SecondaryDays on Antibiotics120 days
SecondaryMortality120 days

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

TypeOutcomeTime framePopulationUnitsMeasured as
PRIMARYNumber of Ventilator-free Days120 daysdaysMEAN
SECONDARYDuration of Hospital Stay120 daysdaysMEAN
SECONDARYDays on Antibiotics120 daysdaysMEAN
SECONDARYMortality120 daysparticipantsNUMBER

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Number of Ventilator-free DaysIntervention95.9Standard Deviation 35.1days
Number of Ventilator-free DaysControl93.6Standard Deviation 37.8days
Duration of Hospital StayIntervention59.6Standard Deviation 33.7days
Duration of Hospital StayControl58.7Standard Deviation 34.5days
Days on AntibioticsIntervention15.7Standard Deviation 19.4days
Days on AntibioticsControl15.0Standard Deviation 19.1days
MortalityIntervention122participants
MortalityControl152participants

Participant flow6

How many started, completed or left each group, period by period.

PeriodMilestoneGroupParticipantsUnits counted
Overall StudySTARTEDIntervention1,511
Overall StudySTARTEDControl1,492
Overall StudyCOMPLETEDIntervention1,500
Overall StudyCOMPLETEDControl1,489
Overall StudyNOT COMPLETEDIntervention11
Overall StudyNOT COMPLETEDControl3

Adverse events2

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

TypeEventOrgan systemGroupAffectedAt riskEvents
seriousMortality [120 days]InvestigationsIntervention1221,500122
seriousMortality [120 days]InvestigationsControl1521,489152

Adverse event totals6

The totals the trial posted for each group.

TotalGroupAffectedAt risk
Total, all-cause mortalityIntervention
Total, all-cause mortalityControl
Total, other adverse eventsIntervention01,500
Total, other adverse eventsControl01,489
Total, serious adverse eventsIntervention1221,500
Total, serious adverse eventsControl1521,489

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
21864846DERIVEDPubMed
24412138DERIVEDPubMed
29703576DERIVEDPubMed
34247026DERIVEDPubMed
34798080DERIVEDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

ComparisonSource
Intervention vs Control: MortalityTrial comparisons
Intervention vs Control: serious adverse eventsTrial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00307333

GET https://conductscience.org/api/trials/v1/NCT00307333/registered