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The NEU-STIM Trial
Sponsor: Leiden University Medical Center
Summary
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.
Official title: A Randomised Trial of Repetitive Versus Selective Tactile Stimulation for Preterm Infants at Birth: The NEU-STIM Trial
Key Details
Gender
All
Age Range
Any - 32 Weeks
Study Type
INTERVENTIONAL
Enrollment
3280
Start Date
2024-03-11
Completion Date
2025-12-31
Last Updated
2025-03-10
Healthy Volunteers
No
Interventions
Repeated tactile stimulation
See arm
Selective tactile stimulation
See arm
Locations (43)
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
University Hospital Carl Gustav Carus
Dresden, Germany
University Hospital Dusseldorf
Düsseldorf, Germany
University Hospital Tubingen
Tübingen, Germany
Aristotle University of Thessaloniki
Thessaloniki, Greece
First dept of Obstetrics and Gynaecology, Semmelweis University
Budapest, Hungary
Second Semmelweis University
Budapest, Hungary
University of Debrecen
Debrecen, Hungary
Bács-Kiskun County Teaching Hospital
Szeged, Hungary
Landspitali University Hospital
Reykjavik, Iceland
National Maternity Hospital
Dublin, Ireland
Coombe Women & Infants University Hospital
Dublin, Ireland
University Hospital Galway
Galway, Ireland
Ospedale dei Bambini Vittore Buzzi
Milan, Italy
Leiden University Medical Center
Leiden, South Holland, Netherlands
Erasmus MC Sophia Kinderziekenhuis
Rotterdam, Netherlands
Haukeland University Hospital
Bergen, Norway
Oslo University Hospital, Ulleval
Oslo, Norway
Oslo University Hospital
Oslo, Norway
Stavanger University Hospital
Stavanger, Norway
University Hospital of North Norway
Tromsø, Norway
St Olav's Hospital Trondheim
Trondheim, Norway
Jan Biziel University Hospital No. 2 in Bydgoszcz
Bydgoszcz, Poland
Medical University of Gdansk
Gdansk, Poland
Medical University of Silesa
Katowice, Poland
University of Medical Sciences
Poznan, Poland
Provincial Hospital
Rzeszów, Poland
Wrocław Medical University
Wroclaw, Poland
Hospital de Braga
Braga, Portugal
University Ovidius of Constanta
Constanța, Romania
Clinical County Emergency Hospital Sibiu
Sibiu, Romania
George Emil Palade University of Medicine
Târgu Mureş, Romania
La Fe University Hospital
Valencia, Spain
University of Health Sciences Sancaktepe Ilhan Varank Training and Research Hospital, Istanbul
Istanbul, Turkey (Türkiye)
Bukovyna State Medical University, Chernivtsi
Chernivtsi, Ukraine
Sumy State University
Sumy, Ukraine