Trial Outcomes & Findings for Impact of Heart Rate Characteristics Monitoring in Neonates (NCT NCT00307333)

NCT ID: NCT00307333

Last Updated: 2013-05-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 3003 participants
• Primary outcome timeframe: 120 days
• Results posted on: 2013-05-27

Participant Flow

Participant milestones

Measure	Intervention Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.	Control Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
Overall Study STARTED	1511	1492
Overall Study COMPLETED	1500	1489
Overall Study NOT COMPLETED	11	3

Reasons for withdrawal

Measure	Intervention Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.	Control Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
Overall Study Lost to Follow-up	11	3

Baseline Characteristics

Impact of Heart Rate Characteristics Monitoring in Neonates

Baseline characteristics by cohort

Measure	Intervention n=1511 Participants Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.	Control n=1492 Participants Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.	Total n=3003 Participants Total of all reporting groups
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age Continuous	0.54 years STANDARD_DEVIATION 0.054 • n=93 Participants	0.54 years STANDARD_DEVIATION 0.054 • n=4 Participants	0.54 years STANDARD_DEVIATION 0.054 • n=27 Participants
Sex: Female, Male Female	791 Participants n=93 Participants	767 Participants n=4 Participants	1558 Participants n=27 Participants
Sex: Female, Male Male	720 Participants n=93 Participants	725 Participants n=4 Participants	1445 Participants n=27 Participants
Region of Enrollment United States	1511 participants n=93 Participants	1492 participants n=4 Participants	3003 participants n=27 Participants
Age, Categorical <=18 years	1511 Participants n=93 Participants	1492 Participants n=4 Participants	3003 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 120 days

Outcome measures

Measure	Intervention n=1500 Participants Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.	Control n=1489 Participants Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
Number of Ventilator-free Days	95.9 days Standard Deviation 35.1	93.6 days Standard Deviation 37.8

SECONDARY outcome

Timeframe: 120 days

Outcome measures

Measure	Intervention n=1511 Participants Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.	Control n=1492 Participants Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
Duration of Hospital Stay	59.6 days Standard Deviation 33.7	58.7 days Standard Deviation 34.5

SECONDARY outcome

Timeframe: 120 days

Outcome measures

Measure	Intervention n=1500 Participants Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.	Control n=1489 Participants Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
Days on Antibiotics	15.7 days Standard Deviation 19.4	15.0 days Standard Deviation 19.1

SECONDARY outcome

Timeframe: 120 days

Outcome measures

Measure	Intervention n=1500 Participants Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.	Control n=1489 Participants Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
Mortality	122 participants	152 participants

Adverse Events

Intervention

Serious events: 122 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 152 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention n=1500 participants at risk Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.	Control n=1489 participants at risk Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
Investigations Mortality [120 days]	8.1% 122/1500 • Number of events 122 • 120 days follow-up	10.2% 152/1489 • Number of events 152 • 120 days follow-up

Other adverse events

Adverse event data not reported

Additional Information

Joseph R. Moorman, MD

University of Virginia

Phone: 434-982-3367

Email: rm3h@virginia.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place