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Search / Trial NCT05942924

The NEU-STIM Trial

Launched by LEIDEN UNIVERSITY MEDICAL CENTER · Jul 11, 2023

Trial Information

Current as of July 01, 2025

Recruiting

Keywords

Preterm Infant Tactile Stimulation Resuscitation

ClinConnect Summary

The NEU-STIM Trial is a research study looking at how different types of gentle touch (called tactile stimulation) can help improve the oxygen levels in premature infants shortly after they are born. Specifically, the study will compare two kinds of touch to see which one is more effective. This trial includes infants who are born before 32 weeks of pregnancy, and parents will need to give their permission for their child to participate.

To join the study, infants must be born early but should not have certain breathing or heart problems that could make their condition worse. During the trial, participating hospitals will follow a specific plan to provide the tactile stimulation to the infants. If your baby is eligible and participates, you can expect them to receive extra gentle touch to see if it helps them breathe better and get more oxygen right after birth. This study is important because it may help improve care for premature babies in the future.

Gender

ALL

Eligibility criteria

  • 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.

About Leiden University Medical Center

Leiden University Medical Center (LUMC) is a prominent academic medical center located in the Netherlands, renowned for its commitment to advancing healthcare through innovative research and high-quality patient care. As a clinical trial sponsor, LUMC focuses on translating scientific discoveries into effective therapies, fostering collaborations between researchers, clinicians, and industry partners. The center is dedicated to conducting rigorous clinical studies across various medical fields, ensuring adherence to ethical standards and regulatory requirements while prioritizing patient safety and outcomes. Through its multidisciplinary approach, LUMC aims to contribute significantly to the understanding and treatment of complex health conditions, driving progress in personalized medicine and improving global health.

Locations

Stavanger, , Norway

Aarhus, , Denmark

Debrecen, , Hungary

Thessaloniki, , Greece

Bergen, , Norway

Galway, , Ireland

Oslo, , Norway

Graz, , Austria

Oslo, , Norway

Reykjavik, , Iceland

Dresden, , Germany

Braga, , Portugal

Dusseldorf, , Germany

Rijeka, , Croatia

Leiden, Zuid Holland, Netherlands

Copenhagen, , Denmark

Graz, Styria, Austria

Sumy, , Ukraine

Tromso, , Norway

Valencia, , Spain

Milan, , Italy

Gdańsk, , Poland

Dublin, , Ireland

Dublin, , Ireland

Liege, , Belgium

Split, , Croatia

Prague, , Czech Republic

Prague, , Czechia

Tubingen, , Germany

Budapest, , Hungary

Budapest, , Hungary

Szeged, , Hungary

Rotterdam, , Netherlands

Trondheim, , Norway

Bydgoszcz, , Poland

Katowice, , Poland

Poznań, , Poland

Rzeszow, , Poland

Wroclaw, , Poland

Constanta, , Romania

Sibiu, , Romania

Targu Mures, , Romania

Istanbul, , Turkey

Chernivtsi, , Ukraine

Prague, , Czechia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported