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Infant, Premature, DiseasesNEU-STIMNCT05942924

The NEU-STIM Trial

A study testing Repeated tactile stimulation and Selective tactile stimulation in people with Infant, Premature, Diseases and Birth, Preterm, run by Leiden University Medical Center at 43 sites in 19 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages Up to 32 weeks
Conditions the study is for
Infant, Premature, Diseases, Birth, Preterm
What is being tested?
Repeated tactile stimulation and Selective tactile stimulation
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,280 participants
Where
43 sitesin 19 countries
Study dates
11 Mar 2024to 31 Dec 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 32 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Infants born before 32 weeks of gestation can be included in this trial after parental consent.

Who cannot join

  • 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.

Trial locations and contacts

43 sites in 19 countries. Contact the study team or a site near you to ask about taking part.

Janneke Dekker, PhD contact

+31715266620

j.dekker@lumc.nl

Colm O'Donnell, MD PhD contact

+35316373100

codonnell@nmh.ie

43 sites in 19 countries

Norway6 sites, 6 recruiting

  • Haukeland University Hospital

    Bergen

    Hans J Guthe, +47 55 97 50 00, Hans.Guthe@uib.no; hjgu@helse-bergen.no

    Recruiting

  • Oslo University Hospital, Ulleval

    Oslo

    Siv Fredly, +47 22 11 80 80, uxsidl@ous-hf.no

    Recruiting

  • Oslo University Hospital

    Oslo

    Anne L Solevag, +47 23 07 00 00, a.l.solevag@medisin.uio.no

    Recruiting

  • Stavanger University Hospital

    Stavanger

    Peder Bjorland, +47 51 51 80 00, peder.aleksander.bjorland@sus.no

    Recruiting

  • University Hospital of North Norway

    Tromsø

    Claus Klingenberg, +47 77 62 60 00, claus.klingenberg@unn.no

    Recruiting

  • St Olav's Hospital Trondheim

    Trondheim

    Ragnhild Stoen, +47 72 57 30 00, ragnhild.stoen@stolav.no

    Recruiting

Other trials in Norway

Poland6 sites, 6 recruiting

  • Jan Biziel University Hospital No. 2 in Bydgoszcz

    Bydgoszcz

    Iwona Sadowska-Krawczenko, +48 52 365 57 99, sadowskakrawczenko@gmail.com; iga.rupniak@gmail.com

    Recruiting

  • Medical University of Gdansk

    Gdansk

    Joanna Jassem-Bobowicz, MD PhD, asiaj@gumed.edu.pl

    Recruiting

  • Medical University of Silesa

    Katowice

    Iwona Maruniak-Chudek, +48 32 208 36 00, ich@mp.pl

    Recruiting

  • University of Medical Sciences

    Poznan

    Tomasz Szczapa, MD PhD, tszczapa@ump.edu.pl

    Recruiting

  • Provincial Hospital

    Rzeszów

    Witold Blaz, +48 17 866 40 00, witekblaz@yahoo.com

    Recruiting

  • Wrocław Medical University

    Wroclaw

    Barbara Krolak-Olejnik, +48 71 733 11 10, olejnik.basia@gmail.com

    Recruiting

Other trials in Poland

Hungary4 sites, 4 recruiting

  • First dept of Obstetrics and Gynaecology, Semmelweis University

    Budapest

    Peter Varga, +36 1 266 0473, pterv79@gmail.com

    Recruiting

  • Second Semmelweis University

    Budapest

    Zsuzsanna Nagy, +36 1 215 1380, zsuzsanagydr@gmail.com

    Recruiting

  • University of Debrecen

    Debrecen

    Tamas Kovacs, +36 52 512 900, kovacst@med.unideb.hu

    Recruiting

  • Bács-Kiskun County Teaching Hospital

    Szeged

    Gyula Talosi, +36 78 564 001, talosigy@gmail.com

    Recruiting

Other trials in Hungary

Germany3 sites, 3 recruiting

  • University Hospital Carl Gustav Carus

    Dresden

    Mario Ruediger, +49 351 4580, mario.ruediger@uniklinikum-dresden.de

    Recruiting

  • University Hospital Dusseldorf

    Düsseldorf

    Janna-Lina Kerth, +49 211 8100, Janna-Lina.Kerth@med.uni-duesseldorf.de

    Recruiting

  • University Hospital Tubingen

    Tübingen

    Laila Springer, +49 7071 290, laila.springer@med.uni-tuebingen.de

    Recruiting

Other trials in Germany

Ireland3 sites, 3 recruiting

  • National Maternity Hospital

    Dublin, D02 YH21

    Colm O'Donnell, MD PhD, +35316373100, codonnell@nmh.ie

    Colm O'Donnell, MD PhD

    Recruiting

  • Coombe Women & Infants University Hospital

    Dublin

    Jan Miletin, +353 1 408 5200, jmiletin@coombe.ie

    Recruiting

  • University Hospital Galway

    Galway

    Johannes Letshwiti, MD, jletshwiti@yahoo.co.uk

    Recruiting

Other trials in Ireland

Romania3 sites, 3 recruiting

  • University Ovidius of Constanta

    Constanța

    Irina Franciuc, +40 241-605002, irina.franciuc@yahoo.ro

    Recruiting

  • Clinical County Emergency Hospital Sibiu

    Sibiu

    Maria Livia Ognean, +40 269-215-050, maria.ognean@ulbsibiu.ro

    Recruiting

  • George Emil Palade University of Medicine

    Târgu Mureş

    Manuela Cucerea, +40 265 262 275, manuelacucerea@yahoo.com

    Recruiting

Other trials in Romania

Croatia2 sites, 2 recruiting

  • Clinical Hospital Center Rijeka

    Rijeka, 51000

    Iva Bilic Cace, MD PhD, +38551658111

    Iva Bilic Cace, MD PhD

    Recruiting

  • Clinical Center Split

    Split

    Anet Papazovska Cherepnalkovski, +385 21 556 111, anet.cherepnalkovski@gmail.com

    Recruiting

Other trials in Croatia

Czechia2 sites, 2 recruiting

  • General Faculty Hospital in Prague

    Prague

    Tereza Lamberska, +420 224 967 732, lamberska.tereza@gmail.com

    Recruiting

  • Institute for Mother and Child Care

    Prague

    Milena Tuskova, MD, milena.tuskova@upmd.eu

    Recruiting

Other trials in Czechia

Denmark2 sites, 2 recruiting

  • Aarhus University Hospital

    Aarhus

    Ulla Christensen, +45 78 45 00 00, ullachri@rm.dk

    Recruiting

  • Rigshospitalet Copenhagen

    Copenhagen

    Christian Heiring, +45 35 45 35 45, christian.Heiring@regionh.dk

    Recruiting

Other trials in Denmark

Netherlands2 sites, 2 recruiting

  • Leiden University Medical Center

    Leiden, South Holland, 2333ZA

    Janneke Dekker, PhD, +31715266620, j.dekker@lumc.nl

    Janneke Dekker, PhD

    Recruiting

  • Erasmus MC Sophia Kinderziekenhuis

    Rotterdam

    Ronny Knol, +31 10 704 0704, r.knol@erasmusmc.nl

    Recruiting

Other trials in Netherlands

Ukraine2 sites, 2 recruiting

  • Bukovyna State Medical University, Chernivtsi

    Chernivtsi

    Anastasiya Babintseva, +380 372 553 754, babintseva@bsmu.edu.ua

    Recruiting

  • Sumy State University

    Sumy

    Viktoriia Petrashenko, +380 542 334 058, v.petrashenko@med.sumdu.edu.ua

    Recruiting

Other trials in Ukraine

Austria1 site, 1 recruiting

  • Medical University of Graz

    Graz, 8036

    Nariae Baik-Schneditz, MD PhD, +433163850

    Nariae Baik-Schneditz, MD PhD

    Recruiting

Other trials in Austria

Belgium1 site, 1 recruiting

  • Liège University Hospital

    Liège

    Vincent Rigo, +32 4 323 00 00, vincent.rigo@chu.ulg.ac.be

    Recruiting

Other trials in Belgium

Greece1 site, 1 recruiting

  • Aristotle University of Thessaloniki

    Thessaloniki

    Kosmas Sarafidis, +30 231 099 6000, kosmas.sarafidis@gmail.com

    Recruiting

Other trials in Greece

Iceland1 site, 1 recruiting

  • Landspitali University Hospital

    Reykjavik

    Sonja Baldursdottir, +354 543 1000, sonjab@landspitali.is

    Recruiting

Other trials in Iceland

Italy1 site, 1 recruiting

  • Ospedale dei Bambini Vittore Buzzi

    Milan

    Francesco Cavigioli, +39 02 63631, francesco.cavigioli@asst-fbf-sacco.it

    Recruiting

Other trials in Italy

Portugal1 site, 1 recruiting

  • Hospital de Braga

    Braga

    Almerinda Barroso Pereira, +351 253 027 000, almerindabarrosopereira@gmail.com

    Recruiting

Other trials in Portugal

Spain1 site, 1 recruiting

  • La Fe University Hospital

    Valencia, 46026

    Celia Barber Almenar, +34961244000

    Celia Barber Almenar

    Not yet recruiting

Other trials in Spain

Turkey (Türkiye)1 site, 1 recruiting

  • University of Health Sciences Sancaktepe Ilhan Varank Training and Research Hospital, Istanbul

    Istanbul

    Tugce Goktas, +90 216 606 33 00, ntugcegoktas@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

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

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.

Read the detailed description

Rationale: A randomised study demonstrated that preterm infants who received repetitive stimulation at birth (10 second episodes of stroking of the soles of the feet and/or back, followed by 10 seconds rest) showed an increase in respiratory effort. This may in turn improve clinical outcomes as improved breathing effort may reduce the need for invasive respiratory support. Tactile stimulation can be immediately and easily performed at birth at no extra cost. It therefore has great potential to be implemented in delivery rooms (DRs) worldwide.

Objective: To determine the effect of repetitive tactile stimulation compared to selective stimulation on oxygenation of the infant at 5 minutes after birth.

Study design: 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.

Study population: Infants born before 32 weeks of gestation will be included in this trial.

Intervention: At the start of the study, each participating centre will perform selective tactile stimulation in accordance with international guidelines, as is their usual practice. Clinicians will gently rub the back, chest, extremities or soles of the feet if they consider the breathing of the infant to be insufficient or absent. In the second stage of the study, centres will be randomised to switch their stimulation approach to repetitive stimulation. Clinicians will then gently rub the back, chest, extremities or soles of the feet for 10 seconds. To avoid extinction of the stimulatory effect (reflex), every 10 second period of stimulation will be followed by 10 seconds of rest (no stimulation). Repetitive stimulation will be performed for the first 5 minutes of life, or longer if the breathing is still considered insufficient or absent.

Main study parameter: The proportion of infants with pre-ductal oxygen saturation (SpO2) ≥ 80%.

Being tested
Repeated tactile stimulation, Selective tactile stimulation
Keywords
Preterm infant, Tactile stimulation, Resuscitation
Medical subject headings
Infant, Premature, Diseases, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Repeated tactile stimulationProcedure or surgery

    See arm

  • Selective tactile stimulationProcedure or surgery

    See arm

Study groups in NCT05942924
Study groupRoleWhat they receive
Selective stimulationActive comparatorAt the start of the study, selective tactile stimulation will be performed at each participating centre in accordance with international guidelines. Clinicians will gently rub the back, chest, extremities or soles of the feet if they consider the breathing of the infant to be insufficient or absent. All other procedures in the delivery room and NICU will be performed according to international and local guidelines.
Receives: Procedure: Selective tactile stimulation
Repeated stimulationExperimentalFor each centre, a lot will be drawn which indicates the month in which the protocol for tactile stimulation changes from selective stimulation to repetitive stimulation. Repetitive stimulation is defined as gently rubbing the soles of the feet, back, chest, or extremities for 10 seconds. To prevent extinction of the stimulatory effect (reflex), every 10 second period of stimulation will be followed by 10 seconds rest (no stimulation). The repetitive stimulation will be performed for the first 5 minutes after birth, or longer if the breathing is still considered insufficient or absent. All other procedures in the delivery room and NICU will be performed according to international and local guidelines.
Receives: Procedure: Repeated tactile stimulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SpO2>80

    Proportion of infants with pre-ductal SpO2 >80%

    Measured: At 5 minutes of life

Secondary outcomes (16)

  1. Heart rate

    Heart rate

    Measured: At 5 minutes after birth

  2. Number of infants who received CPAP <10min

    Number of infants who received continuous positive airway pressure

    Measured: Within 10 minutes after birth

  3. Number of infants who received PPV <10min

    Number of infants who received positive pressure ventilation

    Measured: Within 10 minutes after birth

  4. Number of infants who were intubated <10min

    Number of infants who were endotracheally intubated

    Measured: Within 10 minutes after birth

  5. Number of infants who received chest compressions <10min

    Number of infants who received chest compressions <10min

    Measured: Within 10 minutes after birth

  6. Number of infants who were administered adrenaline <10min

    Adrenaline use

    Measured: Within 10 minutes after birth

  7. Number of infants who were administered volume expansion <10min

    Number of infants who were administered volume expansion <10minv

    Measured: Within 10 minutes after birth

  8. Max FiO2

    Maximum FiO2

    Measured: In the first 10 minutes after birth

  9. Death <10min

    Death <10min

    Measured: Within 10 minutes after birth

  10. Number of infants who were supported by CPAP in first week

    CPAP use in the NICU

    Measured: In the first week after birth

  11. Number of infants who received surfactant in first week

    Surfactant administration via INSURE, LISA or ET tube

    Measured: In the first week after birth

  12. Surfactant doses

    Number of surfactant doses administered

    Measured: In the first week after birth

  13. Number of infants who were mechanically ventilated

    Mechanical ventilation

    Measured: In the first week after birth

  14. Number of infants with abnormalities on the first cranial ultrasound

    Abnormalities on first cranial ultrasound (IVH/PVL)

    Measured: In first week after birth

  15. Death

    Mortality

    Measured: In the first week after birth

  16. Cord clamping time

    The time after birth at which the cord is clamped

    Measured: During resuscitation at birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jul 2023
  2. Study start11 Mar 2024
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a stepped-wedge cluster randomised controlled trial. The participating centre, rather than the individual infant, will be the unit of randomisation.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
3,280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05942924
Sponsor's protocol ID
N22.121
Acronym
NEU-STIM
Status last verified
Mar 2025
First submitted
30 Jun 2023
Last updated
10 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Dekker J, Hooper SB, Martherus T, Cramer SJE, van Geloven N, Te Pas AB. Repetitive versus standard tactile stimulation of preterm infants at birth - A randomized controlled trial. Resuscitation. 2018 Jun;127:37-43. doi: 10.1016/j.resuscitation.2018.03.030. Epub 2018 Mar 23.

    PubMed 29580959

  • Dekker J, O'Donnell CPF, Rudiger M, Te Pas AB, Pauws SC. Repeated versus selective tactile stimulation for preterm infants at birth: protocol and statistical analysis plan for a stepped-wedge cluster randomised controlled trial (NEU-stim trial). BMJ Open. 2026 Jun 2;16(6):e114181. doi: 10.1136/bmjopen-2025-114181.

    PubMed 42229963

Questions about this trial

What is this clinical trial studying?

A study testing Repeated tactile stimulation and Selective tactile stimulation in people with Infant, Premature, Diseases and Birth, Preterm, run by Leiden University Medical Center at 43 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Norway, Poland, Hungary, Germany, Ireland and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Janneke Dekker, PhD (+31715266620, j.dekker@lumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SpO2>80 (time frame: At 5 minutes of life). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05942924, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2025.

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The NEU-STIM Trial (NCT05942924) | AzTrials