The NEU-STIM Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 32
SponsorLeiden University Medical Center
About this 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.
Eligibility criteria
Qualifiers
Infants born before 32 weeks of gestation can be included in this trial after parental consent.
Disqualifiers
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 design
Treatments tested in this trial
- Repeated tactile stimulation
- Selective tactile stimulation
Treatment groups
3,280 Participants
are divided into 2 treatment groupsSponsors and collaborators
Leiden University Medical Center
Lead sponsor
European Society for Paediatric Research
Collaborator
Source ClinicalTrials.gov