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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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German Clinical Trials Register |
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Last refreshed on:
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8 April 2024 |
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Main ID: |
DRKS00010110 |
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Date of registration:
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02/12/2016 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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The usage of a stabilizing cradle and a probe-guiding system while performing the Graf technique of hip sonography – Influence on examination time, infant discomfort and image quality
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Scientific title:
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The usage of a stabilizing cradle and a probe-guiding system while performing the Graf technique of hip sonography – Influence on examination time, infant discomfort and image quality |
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Date of first enrolment:
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30/01/2017 |
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Target sample size:
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75 |
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Recruitment status: |
Recruiting |
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URL:
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http://drks.de/search/en/trial/DRKS00010110 |
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Study type:
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interventional |
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Study design:
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Allocation: Randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: parallel; Study design purpose: diagnostic
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Phase:
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N/A
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Countries of recruitment
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Germany
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Contacts
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Name:
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Selina
Gaida |
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Address:
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Theodor Stern Kai 7
60528
Frankfurt am Main
Germany |
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Telephone:
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015732047602 |
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Email:
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sally.gaida@googlemail.com |
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Affiliation:
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Universitätsklinikum Frankfurt Klinik für Kinder und Jugendmedizin |
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Name:
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Martin
Chmelnik |
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Address:
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Theodor Stern Kai 7
60528
Frankfurt am Main
Germany |
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Telephone:
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015117191139 |
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Email:
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martin.chmelnik@kgu.de |
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Affiliation:
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Universitätsklinikum FrankfurtKlinik für Kinder und Jugendmedizin |
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Key inclusion & exclusion criteria
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Inclusion criteria: The inclusion criteria are defined as follows: newborns and infants as young as 5 weeks of life, informed consent of the persons entitled to custody.
Exclusion criteria: The exclusion criteria are defined as follows: infants that have completed 5 weeks of life, premature babies, small for gestational age.
Age minimum:
1 Days
Age maximum:
5 Weeks
Gender:
All
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Health Condition(s) or Problem(s) studied
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Other congenital deformities of hip
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Q65.8
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Q65.8
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Intervention(s)
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Group 1: Infant hip sonography without any assistant systems
Group 2: Infant hip sonography with a stabilizing cradle in order to stabilise the infant’s position and without a probe-guiding system
Group 3: Infant hip sonography with a stabilizing cradle in order to stabilise the infant’s lateral position and with a probe-guiding system
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Primary Outcome(s)
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In hip sonography the usage of a stabilizing cradle and a probe-guiding system is recommended. Whether the application of these measures offers actual advantages is yet to be examined.
This study shall compare hip sonography without assistance systems with hip sonography procedures supplemented only by stabilizing cradle and secondly hip sonography involving combined usage of stabilizing cradle and a probe-guiding system. The main target figure is the examination time.
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Secondary Outcome(s)
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Further target figures are infant discomfort and image quality. We use the video recordings of each examination for the infant discomfort measured by means of the KUSS scale. The image quality comply with standard checklists including „anatomical identification“ and „usibility testing“ by Graf.
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Source(s) of Monetary Support
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Universitätsklinikum Frankfurt am MainKlinik für Kinder und Jugendmedizin
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Ethics review
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Status: Approved
Approval date: 08/03/2016
Contact:
ethikkommission@kgu.de
Ethikkommission des Fachbereichs Medizin Universitätsklinikum der Goethe-Universität c/o Universitätsklinikum
+49-69-63017239
ethikkommission@kgu.de
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