| NCT ID | NCT05942924 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Leiden University Medical Center |
| Condition | Infant, Premature, Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 3,280 participants |
| Start Date | 2024-03-11 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 3,280 participants in total. It began in 2024-03-11 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05942924 clinical trial?
This trial is open to participants of all sexes, up to 32 Weeks, studying Infant, Premature, Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05942924 currently recruiting?
Yes, NCT05942924 is actively recruiting participants. Contact the research team at j.dekker@lumc.nl for enrollment information.
Where is the NCT05942924 trial being conducted?
This trial is being conducted at Graz, Austria, Liège, Belgium, Rijeka, Croatia, Split, Croatia and 11 additional locations.
Who is sponsoring the NCT05942924 clinical trial?
NCT05942924 is sponsored by Leiden University Medical Center. The trial plans to enroll 3,280 participants.