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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01423942
Other study ID # RMB-0215-11
Secondary ID
Status Completed
Phase N/A
First received August 23, 2011
Last updated May 7, 2015
Start date October 2011
Est. completion date December 2014

Study information

Verified date May 2015
Source Rambam Health Care Campus
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Observational

Clinical Trial Summary

The purpose of this study is to try to evaluate the maturation of the autonomic nervous system in prematures.


Description:

To evaluate the maturation of the autonomic nervous system in prematures by using heart rate variability analyses.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date December 2014
Est. primary completion date December 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 100 Days
Eligibility Inclusion Criteria:

- All prematures

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Israel RMC Haifa

Sponsors (1)

Lead Sponsor Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Herat rate variability (HRV) characteristics It is well known that maturation of the autonomic nervous system can be detected by heart rate variability in children. The purpose of this study is to apply HRV characteristics in premature infants and try to evaluate if there are noticable changes in these parameters both in "healthy" and diseased premature infants longitudinally during their stay at the NICU. Outcome measures to be studied are very low frequency ( VLF), low-frequency ( LF), high frequency (HF) frequency bands in the power spectrum density (PSD) of HRV records. 3 years No
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