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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: |
DRKS00006734 |
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Date of registration:
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10/09/2014 |
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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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Alternation of infants for the prevention and correction of postural skull deformities - Studies concerning the safety of use of a side rail storage
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Scientific title:
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Alternation of infants for the prevention and correction of postural skull deformities - Studies concerning the safety of use of a side rail storage - VARILAG |
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Date of first enrolment:
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03/11/2014 |
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Target sample size:
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50 |
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Recruitment status: |
Complete |
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URL:
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http://drks.de/search/en/trial/DRKS00006734 |
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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: active; Assignment: crossover; Study design purpose: prevention
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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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Gerhard
Jorch |
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Address:
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Leipziger Str. 44
39120
Magdeburg
Germany |
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Telephone:
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0391-67-24000 |
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Email:
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gerhard.jorch@med.ovgu.de |
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Affiliation:
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Universitätskinderklinik Magdeburg |
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Name:
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Uta
Beyer |
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Address:
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Leipziger Str. 44
39120
Magdeburg
Germany |
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Telephone:
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0391-67-24013 |
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Email:
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uta.beyer@med.ovgu.de |
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Affiliation:
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Universitätskinderklinik MagdeburgSchlaflabor |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. premature babies / infants aged betw. 36th week and the end of the seventh month of life
2. written parental consent
Exclusion criteria: 1. acutely ill children
2. after vaccination at a distance less than one week
3. malformation syndromes
4. children with constantly increased oxygen demand
5. children with hydrocephalus and ventriculoperitonealer derivation
Age minimum:
36 Pregnancy
Age maximum:
7 Months
Gender:
All
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Health Condition(s) or Problem(s) studied
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M95.2
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M95.2
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Other acquired deformity of head
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Intervention(s)
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Group 1: 1. only storage of the infant for 4 hours without side-rail storage, then change to storage for 4 hours with side-rail storage
2. monitoring beginning with the Quiet are of the infant to sleep down, recording the parameters using stationary equipment monitoring and documentation of changes in position in a sleep lab
Group 2: 1. only storage of the infant for 4 hours witht side-rail storage, then change to storage for 4 hours without side-rail storage
2. monitoring beginning with the Quiet are of the infant to sleep down, recording the parameters using stationary equipment monitoring and documentation of changes in position in a sleep lab
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Primary Outcome(s)
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Mean of the average oxygen saturation
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Secondary Outcome(s)
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1.% share of sleep at the monitoring time
2.% proportion of quiet sleep
3. RDI (Respiratory Disturbance Index)
4. relevant bradycardia (heart rate below 80 / min.)
5. related apneas (about 15 seconds)
6. desaturation below 90%
7. frequency of position changes in the prone position monitoring time per
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Secondary ID(s)
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CIV-14-07-012442
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U1111-1161-1937
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Source(s) of Monetary Support
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Universitätskinderklinik
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Ethics review
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Status: Approved
Approval date: 18/08/2014
Contact:
ethikkommission@ovgu.de
Ethik-Kommission der Otto-von-Guericke-Universität an der Medizinischen Fakultät und am Universitätsklinikum Magdeburg A.ö.R.
+49-391-6714314
ethikkommission@ovgu.de
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