The NEU-STIM Trial

NCT05942924 · tracked via the Priya Life Science Ireland tracker

Sponsor

Leiden University Medical Center

Phase

Not applicable

Started

2024-03-11

Last updated

2025-03-10

Condition(s) studied

Infant, Premature, DiseasesBirth, Preterm

Investigational drug(s) / intervention(s)

Repeated tactile stimulationSelective tactile stimulation

Repeated tactile stimulation: See arm

Selective tactile stimulation: See arm

Study 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

Sex

ALL

Min age

—

Max age

32 Weeks

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (43)

Facility	City	Region	Status
Medical University of Graz	Graz	Austria	Recruiting
Liège University Hospital	Liège	Belgium	Recruiting
Clinical Hospital Center Rijeka	Rijeka	Croatia	Recruiting
Clinical Center Split	Split	Croatia	Recruiting
General Faculty Hospital in Prague	Prague	Czechia	Recruiting
Institute for Mother and Child Care	Prague	Czechia	Recruiting
Aarhus University Hospital	Aarhus	Denmark	Recruiting
Rigshospitalet Copenhagen	Copenhagen	Denmark	Recruiting
University Hospital Carl Gustav Carus	Dresden	Germany	Recruiting
University Hospital Dusseldorf	Düsseldorf	Germany	Recruiting
University Hospital Tubingen	Tübingen	Germany	Recruiting
Aristotle University of Thessaloniki	Thessaloniki	Greece	Recruiting
First dept of Obstetrics and Gynaecology, Semmelweis University	Budapest	Hungary	Recruiting
Second Semmelweis University	Budapest	Hungary	Recruiting
University of Debrecen	Debrecen	Hungary	Recruiting
Bács-Kiskun County Teaching Hospital	Szeged	Hungary	Recruiting
Landspitali University Hospital	Reykjavik	Iceland	Recruiting
National Maternity Hospital	Dublin	Ireland	Recruiting
Coombe Women & Infants University Hospital	Dublin	Ireland	Recruiting
University Hospital Galway	Galway	Ireland	Recruiting
Ospedale dei Bambini Vittore Buzzi	Milan	Italy	Recruiting
Leiden University Medical Center	Leiden	South Holland	Recruiting
Erasmus MC Sophia Kinderziekenhuis	Rotterdam	Netherlands	Recruiting
Haukeland University Hospital	Bergen	Norway	Recruiting
Oslo University Hospital, Ulleval	Oslo	Norway	Recruiting
Oslo University Hospital	Oslo	Norway	Recruiting
Stavanger University Hospital	Stavanger	Norway	Recruiting
University Hospital of North Norway	Tromsø	Norway	Recruiting
St Olav's Hospital Trondheim	Trondheim	Norway	Recruiting
Jan Biziel University Hospital No. 2 in Bydgoszcz	Bydgoszcz	Poland	Recruiting
Medical University of Gdansk	Gdansk	Poland	Recruiting
Medical University of Silesa	Katowice	Poland	Recruiting
University of Medical Sciences	Poznan	Poland	Recruiting
Provincial Hospital	Rzeszów	Poland	Recruiting
Wrocław Medical University	Wroclaw	Poland	Recruiting
Hospital de Braga	Braga	Portugal	Recruiting
University Ovidius of Constanta	Constanța	Romania	Recruiting
Clinical County Emergency Hospital Sibiu	Sibiu	Romania	Recruiting
George Emil Palade University of Medicine	Târgu Mureş	Romania	Recruiting
La Fe University Hospital	Valencia	Spain	Not Yet Recruiting

+ 3 more sites — see the full list on the official registry below.

More Leiden University Medical Center trials in Ireland

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05942924 on ClinicalTrials.gov ↗ ← All trials in Ireland