NCT05975203 Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
| NCT ID | NCT05975203 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cologne |
| Condition | Preterm Birth |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-08-04 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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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 60 participants in total. It began in 2023-08-04 with a primary completion date of 2026-12-31.
⚠ 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 goal of this randomized controlled trial is to compare the effect of direct skin-to-skin contact in moderate and late preterm infants. The main questions it aims to answer are: * does skin-to-skin contact in moderate and late preterm infants influence gene expression in the stress signaling pathway? * does skin-to-skin contact in moderate and late preterm infants improve the short- and long-term outcome? Participants will either get immediate separation after vaginal birth or receive immediate skin-to-skin contact. Researchers will compare these two groups to answer the proposed questions.
Eligibility Criteria
Inclusion Criteria: * preterm birth between gestational age of 32 0/7 and 36 6/7 weeks * vaginal delivery * singleton * informed consent before birth Exclusion Criteria: * malformations or syndromes of the infant * resuscitation of the infant * maternal psychological or severe physical illness * lack of German language skills
Contact & Investigator
Katrin Mehler, PD Dr.
PRINCIPAL INVESTIGATOR
University of Cologne
Frequently Asked Questions
Who can join the NCT05975203 clinical trial?
This trial is open to participants of all sexes, studying Preterm Birth. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05975203 currently recruiting?
Yes, NCT05975203 is actively recruiting participants. Contact the research team at katrin.mehler@uk-koeln.de for enrollment information.
Where is the NCT05975203 trial being conducted?
This trial is being conducted at Cologne, Germany.
Who is sponsoring the NCT05975203 clinical trial?
NCT05975203 is sponsored by University of Cologne. The principal investigator is Katrin Mehler, PD Dr. at University of Cologne. The trial plans to enroll 60 participants.