Trial document





This trial has been registered retrospectively.
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  DRKS00004775

Trial Description

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Title

Is it possible to reduce with osteopathic manipulative treatment the length of stay of preterm birth children being born beetween gestational week 29 and 36 on an intensive care unit?

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

This study shall answer the question, if osteopathic treatments can make a contribution in care for preterm birth infants by reducing the clinical length of stay.
The study is performed as a randomized clinical trial. The control group receives the standard neonatological treatment. The intervention group gets additional osteopathic treatment.

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Brief Summary in Scientific Language

Preterm birth is according to Liu et al. (2012) the leading course for infant morbidity in the first critical five months of life. According to WHO report "Born Too Soon" (2012), has this phenomen a very notable significance for public health in industrial states (Howson et al.). Merialdi from WHO mentioned 2008 a worldwide burden through preterm birth and "The Lancet" published in 2009 an article with the title "THe Global Burden of Preterm Birth". Preterm birth infants provide an enormous expense factor for the public health system. The costs preterm birth infants cover almost the half (47%) of the expenses for newborn medicine and are up to 25x higher compared to uncomplicated newborns (Russel et al.,2007). Nicholson et al. (2000) speak in this context from an economical burden. A reduction in length of stay of preterm birth infants would lead to enormous cost savings.

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Organizational Data

  •   DRKS00004775
  •   2013/03/07
  •   [---]*
  •   yes
  •   Approved
  •   182_12B, Ethik-Kommission der Friedrich-Alexander-Universität Erlangen-Nürnberg
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Secondary IDs

  •   U1111-1140-3017 
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Health Condition or Problem studied

  •   Preterm birth beetween 29th and 36th pregnancy week
  •   P07.3 -  Other preterm infants
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Interventions/Observational Groups

  •   The osteopathic treatment shall be performed solely with fluidic biodynamic techniques (Dräger et al. 2011). The morphodynamic fields (Liem,2006) of the neurosensual , rhythmic and metabolic systems (Rohen,2002) are going to be treated. It shall be worked with the concept of " Point of Balanced Fluidic Tension" according to Jealous (Liem,2010). The motility on the visceral level shall be treated (Barral,2005). The technique of the First Breath according to Robert Fullford shall be integrated in the treatment. The length of the treatment is one hour. The osteopathic treatment is once a week until discharge.
  •   Children in the control group get the neonatological standard treatment
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

the length of stay in Clinic for Children and Adolescents Fuerth.
The period from admission (birth) to discharge is monitored and documented.

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Secondary Outcome

the gastrointestinal function is monitored and documented in form of frequency of vomiting, food rest in stomach (only with tube fed children), frequency of defecation, weight gain,
the breathing situation is monitored and documented in form of oxygen demand, length of artificial repiration, decrease of oxygen saturation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2012/10/12
  •   40
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Preterm birth children born between 29th and 36th gestational week, born in Klinikum Fuerth

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Exclusion Criteria

Birth before 29th gestational week ; birth after 35th geatational week; genetical disorders; congenital abnormities; cardiovascur abnormities, neurological disorders; suspected or proven NEC with or without gastrointestinal perforation; pre or post surgical patients; pneumothorax; atelectasis; children transferred from another clinic; children whose parents didn`t sign the consent form

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Addresses

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    • Praxis für Osteopathie
    • Mr.  Björn  Langhammer 
    • Jahnstrasse 60
    • 90522  Oberasbach
    • Germany
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    • Praxis für Osteopathie
    • Mr.  Björn  Langhammer 
    • Jahnstrasse 60
    • 90522  Oberasbach
    • Germany
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    • Praxis für Osteopathie
    • Mr.  Björn  Langhammer 
    • Jahnstrasse 60
    • 90522  Oberasbach
    • Germany
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Sources of Monetary or Material Support

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    • Praxis für Osteopathie
    • Mr.  Björn  Langhammer 
    • Jahnstrasse 60
    • 90522  Oberasbach
    • Germany
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Status

  •   Recruiting ongoing
  •   [---]*
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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.