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The NEU-STIM Trial

RecruitingNAAges any - 32 WeeksAllLeiden University Medical Center
NCT05942924 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The aim of this study is to determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth. Infants born before 32 weeks of gestation will be included in this trial. This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation. This design is appropriate to test the effect of an intervention that encompasses a behavioral aspect - in this case the performance of tactile stimulation.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Infants born before 32 weeks of gestation can be included in this trial after parental consent. Exclusion Criteria: * Infants will be excluded if they are found to have a congenital abnormality or condition that has an adverse effect on breathing/ventilation or oxygenation, including: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease and surfactant protein deficiency. Many of the infants enrolled in the study will later be diagnosed with respiratory distress syndrome (RDS); this will not render them ineligible for inclusion.
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What it tests

  • Repeated tactile stimulation
  • Selective tactile stimulation
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Where

43 sites
Medical University of Graz
Graz, Austria
Liège University Hospital
Liège, Belgium
Clinical Hospital Center Rijeka
Rijeka, Croatia
Clinical Center Split
Split, Croatia
General Faculty Hospital in Prague
Prague, Czechia
Institute for Mother and Child Care
Prague, Czechia
Aarhus University Hospital
Aarhus, Denmark
Rigshospitalet Copenhagen
Copenhagen, Denmark

…and 35 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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