NCT01423942

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

May 8, 2015

Status Verified

May 1, 2015

Enrollment Period

2.2 years

First QC Date

August 23, 2011

Last Update Submit

May 7, 2015

Conditions

Analysis, Event History

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age1 Day - 100 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Prematures

You may qualify if:

  • All prematures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

RMC

Haifa, Israel

Location

Study Officials

  • Amir Weissman, MD

    RMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 23, 2011

First Posted

August 26, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2014

Last Updated

May 8, 2015

Record last verified: 2015-05

Locations

IL(1)