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Non Invasive Measurement of Coagulation in Term and Preterm Neonates

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ClinicalTrials.gov Identifier: NCT01167660
Recruitment Status : Unknown
Verified June 2010 by Meir Medical Center.
Recruitment status was:  Recruiting
First Posted : July 22, 2010
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Blood Coagulation Tests Device: The Thrombo-Monitor (ThM)

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 Design

Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non Invasive Measurement of Coagulation in Term and Preterm Neonates
Study Start Date : July 2010
Estimated Primary Completion Date : July 2013
Estimated Study Completion Date : December 2013
Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. Reliability of the non-invasive ThM device. [ Time Frame: From birth up to 1 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Term and preterm babies born in Meir Medical Center
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Congenital anomalies / chromosomal abnormalities
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): NCT01167660


Contacts
Contact: Ita Litmanovitz, MD +972-9-7471554 litmani@clalit.org.il
Contact: Gisela Laura Sirota, MD +972-9-7471554 gisela.sirota@clalit.org.il

Locations
Israel
Meir Medical Center Recruiting
Kfar-Saba, Israel
Contact: Ita Litmanovitz Litmanovitz, MD    09-7471554    litmani@clalit.org.il   
Principal Investigator: Ita Litmanovits, MD         
Sponsors and Collaborators
Meir Medical Center
Investigators
Principal Investigator: Ita Litmanovitz, MD Meir Medical Center
More Information

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01167660     History of Changes
Other Study ID Numbers: Pag-ThM2
First Posted: July 22, 2010    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: June 2010

Keywords provided by Meir Medical Center:
Coagulation tests
Neonates
Non invasive