Trial document




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  DRKS00006734

Trial Description

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Title

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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Trial Acronym

VARILAG

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Since 1991, it is recommended to place infants on their backs to reduce the risk of Sudden Infant Death Syndrome. In addition to the supine position, the lateral position is recommended, but it requires the use of tools in order to achieve a stable and secure storage. This is particularly true for infants who are 3 months and older and dominate the rotation in the prone position and back independently.
The side rail storage offers the possibility to safely stabilize the infant from birth to the end of the seventh month of life in the lateral position and reliably to prevent it rotates in the risky prone position during sleep.
By increasing the variability of storage and the risk of location-related head deformation is avoided, which is connected to the sole backing sheet.

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Brief Summary in Scientific Language

The invariant supine position, in one infant the formation of a preferential attitude with rotation of the head to favor one side (position or rotational preference of the head). Such an attitude asymmetry often leads to a deformation of the head with a flattened occiput side, which is referred to as secondary or postural Plagiozephalus.
The side-rail storage allows a positioning that counteracted the preferred head rotation and a position-related Plagiozephalus. The head rests under side storage fixation on the prominent occipital page on the pad. The weight of the head, the symmetrical shape of the head will be recovered over a period of time, which can be considered as a therapeutic intervention strategy in infantile attitude asymmetry.

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Organizational Data

  •   DRKS00006734
  •   2014/09/10
  •   [---]*
  •   yes
  •   Approved
  •   118/14, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1161-1937 
  •   CIV-14-07-012442 
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Health Condition or Problem studied

  •   M95.2 -  Other acquired deformity of head
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Interventions/Observational Groups

  •   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
  •   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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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Prevention
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Mean of the average oxygen saturation

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Secondary Outcome

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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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/11/03
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   36   Weeks of pregnancy
  •   7   Months
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Additional Inclusion Criteria

1. premature babies / infants aged betw. 36th week and the end of the seventh month of life
2. written parental consent

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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

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Otto-von-Guericke-Universität MagdeburgMedizinische Fakultät
    • Mr.  Prof. Dr. med.  Hermann-Josef  Rothkötter 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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  • start of 1:1-Block address other
    • BOI – DOKUTECH GmbH BOI care&more
    • Mr.  Ernst  Koch 
    • Bahnhofstr. 50
    • 76532  Baden-Baden
    • Germany
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    • Universitätskinderklinik Magdeburg
    • Mr.  Prof. Dr. med.  Gerhard  Jorch 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätskinderklinik MagdeburgSchlaflabor
    • Ms.  OA Dr. med.  Uta  Beyer 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätskinderklinik
    • Mr.  Prof. Dr. med.  Gerhard  Jorch 
    • Leipziger Str. 44
    • 39120 Magdeburg  Magdeburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/12/15
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.