Actively Recruiting
The NEU-STIM Trial
Led by Leiden University Medical Center · Updated on 2025-03-10
3280
Participants Needed
43
Research Sites
94 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
E
European Society for Paediatric Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
The NEU-STIM Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born before 32 weeks of gestation can be included in this trial after parental consent.
You will not qualify if you...
- Infants with congenital abnormalities or conditions that adversely affect breathing or oxygenation, including congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanotic heart disease, and surfactant protein deficiency, are excluded.
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Trial Site Locations
Total: 43 locations
1
Medical University of Graz
Graz, Austria, 8036
Actively Recruiting
2
Liège University Hospital
Liège, Belgium
Actively Recruiting
3
Clinical Hospital Center Rijeka
Rijeka, Croatia, 51000
Actively Recruiting
4
Clinical Center Split
Split, Croatia
Actively Recruiting
5
General Faculty Hospital in Prague
Prague, Czechia
Actively Recruiting
6
Institute for Mother and Child Care
Prague, Czechia
Actively Recruiting
7
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
8
Rigshospitalet Copenhagen
Copenhagen, Denmark
Actively Recruiting
9
University Hospital Carl Gustav Carus
Dresden, Germany
Actively Recruiting
10
University Hospital Dusseldorf
Düsseldorf, Germany
Actively Recruiting
11
University Hospital Tubingen
Tübingen, Germany
Actively Recruiting
12
Aristotle University of Thessaloniki
Thessaloniki, Greece
Actively Recruiting
13
First dept of Obstetrics and Gynaecology, Semmelweis University
Budapest, Hungary
Actively Recruiting
14
Second Semmelweis University
Budapest, Hungary
Actively Recruiting
15
University of Debrecen
Debrecen, Hungary
Actively Recruiting
16
Bács-Kiskun County Teaching Hospital
Szeged, Hungary
Actively Recruiting
17
Landspitali University Hospital
Reykjavik, Iceland
Actively Recruiting
18
National Maternity Hospital
Dublin, Ireland, D02 YH21
Actively Recruiting
19
Coombe Women & Infants University Hospital
Dublin, Ireland
Actively Recruiting
20
University Hospital Galway
Galway, Ireland
Actively Recruiting
21
Ospedale dei Bambini Vittore Buzzi
Milan, Italy
Actively Recruiting
22
Leiden University Medical Center
Leiden, South Holland, Netherlands, 2333ZA
Actively Recruiting
23
Erasmus MC Sophia Kinderziekenhuis
Rotterdam, Netherlands
Actively Recruiting
24
Haukeland University Hospital
Bergen, Norway
Actively Recruiting
25
Oslo University Hospital, Ulleval
Oslo, Norway
Actively Recruiting
26
Oslo University Hospital
Oslo, Norway
Actively Recruiting
27
Stavanger University Hospital
Stavanger, Norway
Actively Recruiting
28
University Hospital of North Norway
Tromsø, Norway
Actively Recruiting
29
St Olav's Hospital Trondheim
Trondheim, Norway
Actively Recruiting
30
Jan Biziel University Hospital No. 2 in Bydgoszcz
Bydgoszcz, Poland
Actively Recruiting
31
Medical University of Gdansk
Gdansk, Poland
Actively Recruiting
32
Medical University of Silesa
Katowice, Poland
Actively Recruiting
33
University of Medical Sciences
Poznan, Poland
Actively Recruiting
34
Provincial Hospital
Rzeszów, Poland
Actively Recruiting
35
Wrocław Medical University
Wroclaw, Poland
Actively Recruiting
36
Hospital de Braga
Braga, Portugal
Actively Recruiting
37
University Ovidius of Constanta
Constanța, Romania
Actively Recruiting
38
Clinical County Emergency Hospital Sibiu
Sibiu, Romania
Actively Recruiting
39
George Emil Palade University of Medicine
Târgu Mureş, Romania
Actively Recruiting
40
La Fe University Hospital
Valencia, Spain, 46026
Not Yet Recruiting
41
University of Health Sciences Sancaktepe Ilhan Varank Training and Research Hospital, Istanbul
Istanbul, Turkey (Türkiye)
Actively Recruiting
42
Bukovyna State Medical University, Chernivtsi
Chernivtsi, Ukraine
Actively Recruiting
43
Sumy State University
Sumy, Ukraine
Actively Recruiting
Research Team
J
Janneke Dekker, PhD
CONTACT
C
Colm O'Donnell, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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