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Maturation of the Autonomic Nervous System in Prematures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01423942
First Posted: August 26, 2011
Last Update Posted: May 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
wamir, Rambam Health Care Campus
  Purpose
The purpose of this study is to try to evaluate the maturation of the autonomic nervous system in prematures.

Condition
Analysis, Event History

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Maturation of the Autonomic Nervous System in Prematures

Further study details as provided by wamir, Rambam Health Care Campus:

Primary Outcome Measures:
  • Herat rate variability (HRV) characteristics [ Time Frame: 3 years ]
    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.


Enrollment: 300
Study Start Date: October 2011
Study Completion Date: December 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Detailed Description:
To evaluate the maturation of the autonomic nervous system in prematures by using heart rate variability analyses.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 100 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Prematures
Criteria

Inclusion Criteria:

  • All prematures
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01423942


Locations
Israel
RMC
Haifa, Israel
Sponsors and Collaborators
Rambam Health Care Campus
Investigators
Principal Investigator: Amir Weissman, MD RMC
  More Information

Responsible Party: wamir, MD, Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01423942     History of Changes
Other Study ID Numbers: RMB-0215-11
First Submitted: August 23, 2011
First Posted: August 26, 2011
Last Update Posted: May 8, 2015
Last Verified: May 2015