Non Invasive Measurement of Coagulation in Term and Preterm Neonates

NCT ID: NCT01167660

Last Updated: 2013-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Blood Coagulation Tests

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy newborn babies

Healthy newborn babies immediately after birth.

The Thrombo-Monitor (ThM)

Intervention Type DEVICE

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.

The Thrombo-Monitor (ThM)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Congenital anomalies / chromosomal abnormalities
Maximum Eligible Age

2 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ita Litmanovitz, MD

Role: PRINCIPAL_INVESTIGATOR

Meir Medical Center

Locations

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Meir Medical Center

Kfar Saba, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Ita Litmanovitz, MD

Role: CONTACT

+972-9-7471554

Gisela Laura Sirota, MD

Role: CONTACT

+972-9-7471554

Facility Contacts

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Ita Litmanovitz Litmanovitz, MD

Role: primary

09-7471554

Other Identifiers

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Pag-ThM2

Identifier Type: -

Identifier Source: org_study_id

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