Effect of tactile stimulation on oxygen levels in preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Study coordinator: Janneke Dekker, PhD
• Email: j.dekker@lumc.nl
• Phone: +31715266620

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.