Trial document



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  DRKS00013094

Trial Description

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Title

Early and continuously raising of blood pressure may prevent fluctuations of cerebral blood flow in very low birth weight infants (VLBW) especially in VLBW infants without cerebral autoregulation!

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Arterial hypotension is common in preterm infants with low gestational ages, and it is often diagnosed and treated. Although there have been recent advancements in the management and outcomes of these preterm infants, the ideal blood pressure for a preterm infant is unclear. Consequently, the necessary blood pressure for adequate cerebral perfusion is still unknown and discussion about this topic is controversial. In addition to the management of arterial hypotension in preterm infants, the choice of treatment and the associated benefits and risks are widely discussed since the treatment plans for arterial hypotension in preterm infants with low gestational ages are highly variable.
Cerebrovascular autoregulation is a protective mechanism of the brain and there is conflicting evidence about whether these preterm infants have such a protective mechanism.

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Brief Summary in Scientific Language

Arterial hypotension is common in preterm infants with low gestational ages, and it is often diagnosed and treated. Certain centres aim to achieve a mean arterial pressure (MAP) of above 30 mmHg, while others attempt to achieve a MAP above the gestational age in weeks, and others only provide treatment when there are other signs of poor perfusion, such as prolonged capillary refill time, increased heart rate, decreased urinary output, metabolic acidosis, and increased lactate levels.
Many studies demonstrate that there is an association between postnatal hypotension in preterm infants with low gestational ages and the incidence of severe intraventricular haemorrhage (IVH) or death. Within certain limits, cerebral vessels adapt to fluctuations in blood pressure to achieve a constant cerebral blood flow. This cerebrovascular autoregulation is a protective mechanism of the brain and there is conflicting evidence about whether these preterm infants have such a protective mechanism. In the absence of this protective mechanism, fluctuations in blood pressure cause fluctuations in cerebral blood flow, which lead to cerebral hypoperfusion or hyperperfusion. It is likely that the absence of cerebral autoregulation in these preterm infants is a risk factor for developing a severe intraventricular haemorrhage (IVH).

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Organizational Data

  •   DRKS00013094
  •   2017/10/05
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  •   yes
  •   Approved
  •   S-088/2010, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

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Health Condition or Problem studied

  •   P07 -  Disorders related to short gestation and low birth weight, not elsewhere classified
  •   I95 -  Hypotension
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Interventions/Observational Groups

  •   During the first 72 hours of life the cerebral saturation, MAP and remaining vital signs are recorded. Arterial hypotension is defined at the University Hospital of Heidelberg as a MAP of less than 30 mmHg. According to the clinical internal standards, premature babies receive volume therapy, followed by hydrocortisone therapy and finally additional catecholamines. Depending on their needs, the children are divided into different groups: premature babies without therapy, premature babies with volume therapy, premature babies with volume therapy, and hydrocortisone therapy and premature babies with volume therapy, hydrocortisone and catecholamine therapy. The therapy is carried out according to the clinic's internal standard, independent of this study. The children are divided into 4 groups according to their needs.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   No
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Primary Outcome

Mean arterial blood pressure is observed in premature infants during the first 72 hours of life without and with hypotension therapy. If a central arterial catheter is indwelled, the arterial blood pressure is monitored continuously. Otherwise, non-invasive measurements are obtained using the oscillometric technique with an appropriate-sized cuff.

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Secondary Outcome

During the first 72 hours of life the cerebral saturation is measured using near infrared spectroscopy, a non-invasive, continuous bedside measurement technique. The cerebral fractional tissue oxygen extraction can be calculated from this, which is an indirect measure of cerebral blood flow. In addition, the vital signs including blood pressure are recorded during routine monitoring. If a central arterial catheter is indwelled, the arterial blood pressure is monitored continuously. Otherwise, non-invasive measurements are obtained using the oscillometric technique. The mean arterial pressure and cerebral fractional tissue oxygen extraction are correlated. If there is cerebral autoregulation in premature infants, fluctuations of the MAP have no influence on the cerebral blood flow, i. e. there is no correlation.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Actual
  •   2017/10/16
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   23   Weeks of pregnancy
  •   30   Weeks of pregnancy
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Additional Inclusion Criteria

preterm infant with a gestational age less than 30 weeks

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Exclusion Criteria

heart failure

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Addresses

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    • Kinderklinik Heidelberg, Abteilung Neonatologie
    • Mr.  Prof. Dr  Johannes  Pöschl 
    • Im Neuenheimer Feld 430
    • 69120  Heidelberg
    • Germany
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    • Kinderklinik Heidelberg, Abteilung Neonatologie
    • Ms.  Dr  Tina  Heinzmann 
    • Im Neuenheimer Feld 430
    • 69120  Heidelberg
    • Germany
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    • Kinderklinik Heidelberg, Abteilung Neonatologie
    • Ms.  Dr  Tina  Heinzmann 
    • Im Neuenheimer Feld 430
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Kinderklinik Heidelberg, Abteilung Neonatologie
    • Mr.  Prof. Dr.  Johannes  Pöschl 
    • Im Neuenheimer Feld 430
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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