Trial document





This trial has been registered retrospectively.
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  DRKS00007171

Trial Description

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Title

Nasal noninvasive high frequency oscillatory ventilation in premature infants below 32 weeks gestational age - a pilot study

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Trial Acronym

Nasal HFOV for premature infants

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Preterm infants need respiratory support after being born. If they suffer from only mild respiratory distress the baby breathing might be assisted by a small nasal mask providing a constant air flow, this mode being called CPAP. It has shown that this kind of so called non invasive respiratory support may help those preterm infants to stabilize their breathing and contributes to avoid more invasive means of respiratory support. We are researching whether CPAP might actually be more effective when an oscillating air flow is being used. Our aim is to determine if these oscillations might improve respiratory stability in term of levels of carbon dioxide in these infants.

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Brief Summary in Scientific Language

Nasal high frequency oscillatory ventilation (nHFOV) is a new mode of noninvasive neonatal respiratory support. An oscillatory pressure waveform is applied over a constant gas flow to the airways using a nasal or nasopharyngeal interface thus combining effects of nasal continuous positive airway pressure (nCPAP) and high frequency oscillatory ventilation. nHFOV is described both in bench studies and case series to be superior to nCPAP in terms of CO2 elimination and is utilized in an number of neonatal unit throughout Europe. However, there are no randomised controlled trials comparing nHFOV to any other mode of respiratory support. In this trial we are treating premature infants < 32 weeks of gestational age with 4 hours of nCPAP and 4 hours of nHFOV in an crossover design. Infants will be randomly assigned to the sequence of mode of respiratory support. Infants received surfactant or were extubated less than 24 hours prior to randomization. We hypothesise nHFOV to be significantly more effective in terms of CO2 elimination compared to nCPAP.

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Organizational Data

  •   DRKS00007171
  •   2015/06/16
  •   [---]*
  •   yes
  •   Approved
  •   204/14, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

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Health Condition or Problem studied

  •   CO2 clearance using nasal high frequency oscillation
  •   [---]* -  [---]*
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Interventions/Observational Groups

  •   Premature infants < 32 weeks of gestational age will be treated 4 hours with nCPAP and 4 h with nHFOV using a crossover design within 24 hours after being extubated or receiving surfactant. Allocation to the treatment sequence will be randomized. CO2-Partial pressures after 4 h of each treatment will be compared.
  •   nCPAP (4h) - nHFOV (4h)
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Crossover
  •   N/A
  •   No
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Primary Outcome

Invasive measurement of partial pressure of carbon dioxide after 4 h nHFOV vs 4 h nCPAP

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Secondary Outcome

• Amplitude to achieve visible, adequate oscillation
• mean airway pressure
• need for intubation (failure of noninvasive ventilation per period)
• Number of apnea/bradycardia per period
• Respiratory rate*
• Heart rate*
• EDIN-Painscore*
• SpO2*
• FiO2*
• pO2*
• Transcutaneous pCO2

*after 4 hours of each type of ventilation

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2014/07/20
  •   26
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   28   Days
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Additional Inclusion Criteria

1. Premature infants < 32 weeks gestational age
2. 0-24 h after extubation or 0-24 hours after application of Surfactant
3. Respiratory insuficiency on non-invasive respiratory support (nasal CPAP)
3. PCO2 > 45 mmHg
4. Informed consent of caretakers

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Exclusion Criteria

1. Upper airway malformation leading to incompatibility with noninvasive ventilation
2. Known chomosomal abnormalities
3. Palliative/comfort care only.

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Addresses

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    • Universitätsklinikum Freiburg
    • Hugstetter Strasse 49
    • 79095  Freiburg
    • Germany
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    • Universitätskinderklinik Freiburg, Abteilung für Neonatologie
    • Mr.  PD Dr.   Hans  Fuchs 
    • Mathildenstr. 1, 79106 Freiburg
    • 79106   Freiburg
    • Germany
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    • Universitätskinderklinik Freiburg, Abteilung für Neonatologie
    • Mr.  Dr.   Daniel  Klotz 
    • Mathildenstr. 1
    • 79106  Freiburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätskinderklinik Freiburg; Klinik 1
    • Ms.  Prof. Dr. med.   Ute   Spiekerkötter 
    • Mathildenstrasse 1
    • 79106  Freiburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2016/09/23
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Trial Publications, Results and other Documents

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