Effect of tactile stimulation on oxygen levels in preterm infants
A Randomised Trial of Repetitive Versus Selective Tactile Stimulation for Preterm Infants at Birth: The NEU-STIM Trial
This study tests if gently stroking the feet and back of preterm infants right after birth can help improve their oxygen levels.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3280 (estimated) |
| Ages | N/A to 32 Weeks |
| Sex | All |
| Sponsor | Leiden University Medical Center Academic / other |
| Locations | 43 sites (Graz and 42 other locations) |
| Trial ID | NCT05942924 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the impact of repetitive tactile stimulation versus selective stimulation on the oxygenation of preterm infants born before 32 weeks of gestation, measured at 5 minutes after birth. It employs a stepped-wedge cluster randomised controlled design, where the participating center is the unit of randomisation rather than individual infants. The rationale is based on previous findings that repetitive tactile stimulation can enhance respiratory effort, potentially improving clinical outcomes and reducing the need for invasive respiratory support. The intervention involves gentle stroking of the infant's feet and back, which can be easily implemented in delivery rooms worldwide.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born before 32 weeks of gestation whose parents provide consent.
Not a fit: Patients with congenital abnormalities or conditions adversely affecting breathing or oxygenation will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve oxygenation and respiratory outcomes for preterm infants, leading to better overall health and reduced need for intensive care.
How similar studies have performed: Previous studies have shown positive outcomes with similar tactile stimulation approaches, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Graz and 42 other locations
- 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, Netherlands (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)
- University of Health Sciences Sancaktepe Ilhan Varank Training and Research Hospital, Istanbul — Istanbul, Turkey (Türkiye) (Recruiting)
- Bukovyna State Medical University, Chernivtsi — Chernivtsi, Ukraine (Recruiting)
- Sumy State University — Sumy, Ukraine (Recruiting)
Study contacts
- Study coordinator: Janneke Dekker, PhD
- Email: j.dekker@lumc.nl
- Phone: +31715266620
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.