Trial document




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  DRKS00003433

Trial Description

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Title

Impact of noise to intermittent hypoxia and bradycardia in preterm infants. A randomized controlled trial.

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Trial Acronym

NAOP

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URL of the Trial

[---]*

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Brief Summary in Lay Language

To test the impact of noise protection on the occurrence of apnea and bradycardia in 31 preterm infants. Premature infants have a common problem that they make pauses in breathing and the heart beats are too slowly. We want to test if an ear protection against untypical neonatal noise brings better outcome for breathing and heart beat.

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Brief Summary in Scientific Language

Apnea of prematurity can cause serious problems. Environmental acoustic stimuli may cause agitation and seem to play an important role. We aim to evaluate the occurrence of pulse oximetry-derived desaturation and bradycardia under continuous environmental noise recording in a randomized controlled trial including 31 preterm infants. By using a cross-over study design, subjects receive and do not receive noise protection for 2 hours each in a randomized order. A clinically relevant and statistically significant reduction in the occurrence of hypoxia and bradycardia should be proven.

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Organizational Data

  •   DRKS00003433
  •   2012/05/10
  •   [---]*
  •   yes
  •   Approved
  •   245/2012BO1, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  •   U1111-1129-7733 
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Health Condition or Problem studied

  •   R06.8 -  Other and unspecified abnormalities of breathing
  •   P07.2 -  Extreme immaturity
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Interventions/Observational Groups

  •   cross-over design: MiniMuffs® as an ear protection then no intervention
  •   cross-over design: no intervention then MiniMuffs® as an ear protection
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Blinded
  •   assessor, data analyst
  •   No treatment
  •   Basic research/physiological study
  •   Crossover
  •   N/A
  •   N/A
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Primary Outcome

Occurrence of pulse oximeter saturation below 80% per h, measurements last 2 h with and 2 h without intervention (ear protection).

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Secondary Outcome

Occurrence of heart beat under 80 beate per minute per h, measurements last 2 h with and 2 h without intervention (ear protection).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/05/09
  •   31
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   24   Weeks
  •   37   Weeks
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Additional Inclusion Criteria

Patients of the local neonatal intensive care unit; presentation of apnea of prematurity; parents agreement

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Exclusion Criteria

Redemtion of the parents agreement

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Addresses

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    • Universitätsklinik für Kinder- und Jugendmedizin; Abt. IV Neonatologie
    • Ms.  Dr.med.  Anette  Poets 
    • Calwerstr.7
    • 72076  Tübingen
    • Germany
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    • Universitätsklinikum für Kinder- und Jugendmedizin; Abt. IV Neonatologie
    • Ms.  Dr.med.  Anette  Poets 
    • Calwerstr.7
    • 72076  Tübingen
    • Germany
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    • Universitätsklinik für Kinder- und Jugendmedizin; Abt. IV Neonaologie
    • Mr.  Thomas Sebastian  Bott 
    • Calwerstr.7
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum für Kinder- und Jugendmedizin; Abt. IV Neonatologie
    • Mr.  Prof.Dr.med.  Christian Friedrich  Poets 
    • Calwerstr.7
    • 72076  Tübingen
    • Germany
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    • Medizinische Fakultät Tübingen; Bereich Akademische Angelegenheiten; IZKF Promotionskolleg
    • Ms.  Dr.  Tanja  Rieß 
    • Geissweg 5
    • 72076  Tübingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2012/12/12
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* This entry means the parameter is not applicable or has not been set.