Maturation of the Autonomic Nervous System in Prematures

Completed

• Conditions: Analysis, Event History

• Registration Number: NCT01423942
• Lead Sponsor: Rambam Health Care Campus

Brief Summary

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

Detailed Description

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

Study Timeline

• Study First Submitted: 2011-08-23
• Study First Submitted QC: 2011-08-24
• Study First Posted: 2011-08-26
• Study Start: 2011-10
• Primary Completion: 2013-12
• Study Completion: 2014-12
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-07
• Last Update Posted: 2015-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• All prematures

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Herat rate variability (HRV) characteristics	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.

Trial Locations

Locations (1)

RMC; 🇮🇱 Haifa, Israel