The NEU-STIM Trial

Last updated: March 5, 2025
Sponsor: Leiden University Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Selective tactile stimulation

Repeated tactile stimulation

Clinical Study ID

NCT05942924
N22.121
  • Ages < 32
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • Infants will be excluded if they are found to have a congenital abnormality orcondition that has an adverse effect on breathing/ventilation or oxygenation,including: congenital diaphragmatic hernia, trachea-oesophageal fistula, cyanoticheart disease and surfactant protein deficiency. Many of the infants enrolled in thestudy will later be diagnosed with respiratory distress syndrome (RDS); this willnot render them ineligible for inclusion.

Study Design

Total Participants: 3280
Treatment Group(s): 2
Primary Treatment: Selective tactile stimulation
Phase:
Study Start date:
March 11, 2024
Estimated Completion Date:
December 31, 2025

Study 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%.

Connect with a study center

  • Medical University of Graz

    Graz, 8036
    Austria

    Active - Recruiting

  • Liège University Hospital

    Liege,
    Belgium

    Active - Recruiting

  • Clinical Hospital Center Rijeka

    Rijeka, 51000
    Croatia

    Active - Recruiting

  • Clinical Center Split

    Split,
    Croatia

    Active - Recruiting

  • General Faculty Hospital in Prague

    Prague,
    Czech Republic

    Active - Recruiting

  • Institute for Mother and Child Care

    Prague,
    Czechia

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus,
    Denmark

    Active - Recruiting

  • Rigshospitalet Copenhagen

    Copenhagen,
    Denmark

    Active - Recruiting

  • University Hospital Carl Gustav Carus

    Dresden,
    Germany

    Active - Recruiting

  • University Hospital Dusseldorf

    Dusseldorf,
    Germany

    Active - Recruiting

  • University Hospital Tubingen

    Tubingen,
    Germany

    Active - Recruiting

  • Aristotle University of Thessaloniki

    Thessaloniki,
    Greece

    Active - Recruiting

  • First dept of Obstetrics and Gynaecology, Semmelweis University

    Budapest,
    Hungary

    Active - Recruiting

  • Second Semmelweis University

    Budapest,
    Hungary

    Active - Recruiting

  • University of Debrecen

    Debrecen,
    Hungary

    Active - Recruiting

  • Bács-Kiskun County Teaching Hospital

    Szeged,
    Hungary

    Active - Recruiting

  • Landspitali University Hospital

    Reykjavik,
    Iceland

    Active - Recruiting

  • Coombe Women & Infants University Hospital

    Dublin,
    Ireland

    Active - Recruiting

  • National Maternity Hospital

    Dublin, D02 YH21
    Ireland

    Active - Recruiting

  • University Hospital Galway

    Galway,
    Ireland

    Active - Recruiting

  • Ospedale dei Bambini Vittore Buzzi

    Milan,
    Italy

    Active - Recruiting

  • Leiden University Medical Center

    Leiden, Zuid-Holland 2333ZA
    Netherlands

    Active - Recruiting

  • Erasmus MC Sophia Kinderziekenhuis

    Rotterdam,
    Netherlands

    Active - Recruiting

  • Haukeland University Hospital

    Bergen,
    Norway

    Active - Recruiting

  • Oslo University Hospital

    Oslo,
    Norway

    Active - Recruiting

  • Oslo University Hospital, Ulleval

    Oslo,
    Norway

    Active - Recruiting

  • Stavanger University Hospital

    Stavanger,
    Norway

    Active - Recruiting

  • University Hospital of North Norway

    Tromso,
    Norway

    Active - Recruiting

  • St Olav's Hospital Trondheim

    Trondheim,
    Norway

    Active - Recruiting

  • Jan Biziel University Hospital No. 2 in Bydgoszcz

    Bydgoszcz,
    Poland

    Active - Recruiting

  • Medical University of Gdansk

    Gdańsk,
    Poland

    Active - Recruiting

  • Medical University of Silesa

    Katowice,
    Poland

    Active - Recruiting

  • University of Medical Sciences

    Poznań,
    Poland

    Active - Recruiting

  • Provincial Hospital

    Rzeszow,
    Poland

    Active - Recruiting

  • Wrocław Medical University

    Wroclaw,
    Poland

    Active - Recruiting

  • Hospital de Braga

    Braga,
    Portugal

    Active - Recruiting

  • University Ovidius of Constanta

    Constanta,
    Romania

    Active - Recruiting

  • Clinical County Emergency Hospital Sibiu

    Sibiu,
    Romania

    Active - Recruiting

  • George Emil Palade University of Medicine

    Targu Mures,
    Romania

    Active - Recruiting

  • La Fe University Hospital

    Valencia, 46026
    Spain

    Site Not Available

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

    Istanbul,
    Turkey

    Active - Recruiting

  • Bukovyna State Medical University, Chernivtsi

    Chernivtsi,
    Ukraine

    Active - Recruiting

  • Sumy State University

    Sumy,
    Ukraine

    Active - Recruiting

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