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The NEU-STIM Trial

NCT05942924 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3280

Last updated 2025-03-10

No results posted yet for this 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.

Conditions

  • Infant, Premature, Diseases
  • Birth, Preterm

Interventions

PROCEDURE

Repeated tactile stimulation

See arm

PROCEDURE

Selective tactile stimulation

See arm

Sponsors & Collaborators

  • European Society for Paediatric Research

    collaborator UNKNOWN

  • Leiden University Medical Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-11
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Austria
  • Belgium
  • Croatia
  • Czechia
  • Denmark
  • Germany
  • Greece
  • Hungary
  • Iceland
  • Ireland
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Romania
  • Spain
  • Turkey (Türkiye)
  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05942924 on ClinicalTrials.gov