RecruitingNot ApplicableNCT05942924

The NEU-STIM Trial

A Randomised Trial of Repetitive Versus Selective Tactile Stimulation for Preterm Infants at Birth: The NEU-STIM Trial

Sponsor

Leiden University Medical Center

Enrollment

3,280 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

Infant, Premature, Diseases Birth, Preterm

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.

Eligibility

Max Age: 32 Weeks

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a procedure called Repeated tactile stimulation and a procedure called Selective tactile stimulation for people with birth, preterm and infant, premature, diseases. The study is currently recruiting participants at 43 locations. People eligible for this study include up to age 32 Weeks.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERepeated tactile stimulation

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PROCEDURESelective tactile stimulation

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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

View Full Details on ClinicalTrials.gov

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NCT05942924

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