Non Invasive Measurement of Coagulation in Term and Preterm Neonates

February 11, 2013 updated by: Meir Medical Center
The purpose of this study is to assess the reliability of a new non-invasive device to assess the blood coagulation status among term and preterm babies.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Coagulation abnormalities among neonates aren't common - but can be life threatening. Testing the coagulation system in small babies involves drawing significant amounts of blood (especially in premature babies). Non-invasive testing can help assess and treat term and preterm neonates at risk. Recently, a non-invasive device to assess the blood coagulation status was developed - The Thrombo-Monitor (ThM). The objective of this study is to assess the reliability of this new non-invasive device among term and preterm babies by comparing the result of the ThM reading to coagulation analysis from blood.

Study Type

Observational

Enrollment (Anticipated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Kfar-Saba, Israel
        • Recruiting
        • Meir Medical Center
        • Contact:
        • Principal Investigator:
          • Ita Litmanovits, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 months (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Term and preterm babies born in Meir Medical Center

Description

Inclusion Criteria:

  • Newborn babies - term and preterm
  • Written parental informed consent

Exclusion Criteria:

  • Congenital anomalies / chromosomal abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy newborn babies
Healthy newborn babies immediately after birth.
Device: The Thrombo-Monitor (ThM)
Non-invasive measurement of coagulation status and comparison to standard blood coagulation tests. In healthy neonates - immediately after birth, before the administration of vitamin K. Coagulation tests will be done on an umbilical cord blood sample. In sick neonates, coagulation studies will be done according to the medical condition.
Sick newborn babies
Sick newborn babies whose medical condition indicates performing coagulation tests.
Device: The Thrombo-Monitor (ThM)
Non-invasive measurement of coagulation status and comparison to standard blood coagulation tests. In healthy neonates - immediately after birth, before the administration of vitamin K. Coagulation tests will be done on an umbilical cord blood sample. In sick neonates, coagulation studies will be done according to the medical condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Reliability of the non-invasive ThM device.
Time Frame: From birth up to 1 month
From birth up to 1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Meir Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (ANTICIPATED)

July 1, 2013

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

July 5, 2010

First Submitted That Met QC Criteria

July 21, 2010

First Posted (ESTIMATE)

July 22, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

June 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Pag-ThM2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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