Brief 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.

Conditions

• Infant, Premature, Diseases
• Birth, Preterm

Intervention / Treatment

• Procedure: Repeated tactile stimulation
• Procedure: Selective tactile stimulation

Primary Outcome Measures

• SpO2>80 (At 5 minutes of life)
  Proportion of infants with pre-ductal SpO2 \>80%

Countries

Austria, Belgium, Croatia, Czech Republic, Czechia, Denmark, Germany, Greece, Hungary, Iceland, Ireland, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Turkey, Ukraine

Locations and Investigators

• Medical University of Graz, Graz, Austria (Recruiting)
  • Nariae Baik-Schneditz, MD PhD
  • Nariae Baik-Schneditz, MD PhD
• Liège University Hospital, Liege, Belgium (Recruiting)
  • Vincent Rigo
• Clinical Hospital Center Rijeka, Rijeka, Croatia (Recruiting)
  • Iva Bilic Cace, MD PhD
  • Iva Bilic Cace, MD PhD
• Clinical Center Split, Split, Croatia (Recruiting)
  • Anet Papazovska Cherepnalkovski
• General Faculty Hospital in Prague, Prague, Czech Republic (Recruiting)
  • Tereza Lamberska
• Institute for Mother and Child Care, Prague, Czechia (Recruiting)
  • Milena Tuskova, MD
• Aarhus University Hospital, Aarhus, Denmark (Recruiting)
  • Ulla Christensen
• Rigshospitalet Copenhagen, Copenhagen, Denmark (Recruiting)
  • Christian Heiring
• University Hospital Carl Gustav Carus, Dresden, Germany (Recruiting)
  • Mario Ruediger
• University Hospital Dusseldorf, Dusseldorf, Germany (Recruiting)
  • Janna-Lina Kerth
• University Hospital Tubingen, Tubingen, Germany (Recruiting)
  • Laila Springer
• Aristotle University of Thessaloniki, Thessaloniki, Greece (Recruiting)
  • Kosmas Sarafidis
• First dept of Obstetrics and Gynaecology, Semmelweis University, Budapest, Hungary (Recruiting)
  • Peter Varga
• Second Semmelweis University, Budapest, Hungary (Recruiting)
  • Zsuzsanna Nagy
• University of Debrecen, Debrecen, Hungary (Recruiting)
  • Tamas Kovacs
• Bács-Kiskun County Teaching Hospital, Szeged, Hungary (Recruiting)
  • Gyula Talosi
• Landspitali University Hospital, Reykjavik, Iceland (Recruiting)
  • Sonja Baldursdottir
• National Maternity Hospital, Dublin, Ireland (Recruiting)
  • Colm O'Donnell, MD PhD
  • Colm O'Donnell, MD PhD
• Coombe Women & Infants University Hospital, Dublin, Ireland (Recruiting)
  • Jan Miletin
• University Hospital Galway, Galway, Ireland (Recruiting)
  • Johannes Letshwiti, MD
• Ospedale dei Bambini Vittore Buzzi, Milan, Italy (Recruiting)
  • Francesco Cavigioli
• Leiden University Medical Center, Leiden, Netherlands (Recruiting)
  • Janneke Dekker, PhD
  • Janneke Dekker, PhD
• Erasmus MC Sophia Kinderziekenhuis, Rotterdam, Netherlands (Recruiting)
  • Ronny Knol
• Haukeland University Hospital, Bergen, Norway (Recruiting)
  • Hans J Guthe
• Oslo University Hospital, Ulleval, Oslo, Norway (Recruiting)
  • Siv Fredly
• Oslo University Hospital, Oslo, Norway (Recruiting)
  • Anne L Solevag
• Stavanger University Hospital, Stavanger, Norway (Recruiting)
  • Peder Bjorland
• University Hospital of North Norway, Tromso, Norway (Recruiting)
  • Claus Klingenberg
• St Olav's Hospital Trondheim, Trondheim, Norway (Recruiting)
  • Ragnhild Stoen
• Jan Biziel University Hospital No. 2 in Bydgoszcz, Bydgoszcz, Poland (Recruiting)
  • Iwona Sadowska-Krawczenko
• Medical University of Gdansk, Gdańsk, Poland (Recruiting)
  • Joanna Jassem-Bobowicz, MD PhD
• Medical University of Silesa, Katowice, Poland (Recruiting)
  • Iwona Maruniak-Chudek
• University of Medical Sciences, Poznań, Poland (Recruiting)
  • Tomasz Szczapa, MD PhD
• Provincial Hospital, Rzeszow, Poland (Recruiting)
  • Witold Blaz
• Wrocław Medical University, Wroclaw, Poland (Recruiting)
  • Barbara Krolak-Olejnik
• Hospital de Braga, Braga, Portugal (Recruiting)
  • Almerinda Barroso Pereira
• University Ovidius of Constanta, Constanta, Romania (Recruiting)
  • Irina Franciuc
• Clinical County Emergency Hospital Sibiu, Sibiu, Romania (Recruiting)
  • Maria Livia Ognean
• George Emil Palade University of Medicine, Targu Mures, Romania (Recruiting)
  • Manuela Cucerea
• La Fe University Hospital, Valencia, Spain (Not yet recruiting)
  • Celia Barber Almenar
  • Celia Barber Almenar
  • Maximo Vento, MD PhD
• University of Health Sciences Sancaktepe Ilhan Varank Training and Research Hospital, Istanbul, Istanbul, Turkey (Recruiting)
  • Tugce Goktas
• Bukovyna State Medical University, Chernivtsi, Chernivtsi, Ukraine (Recruiting)
  • Anastasiya Babintseva
• Sumy State University, Sumy, Ukraine (Recruiting)
  • Viktoriia Petrashenko