Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:
• preterm birth between gestational age of 32 0/7 and 36 6/7 weeks
• vaginal delivery
• singleton
• informed consent before birth
Locations
Other Locations
Germany
University hospital of Cologne, Department of Neonatology
RECRUITING
Cologne
Contact Information
Primary
Katrin Mehler, PD Dr.
katrin.mehler@uk-koeln.de
004922147885663
Backup
Angela Kribs, PD Dr.
angela.kribs@uk-koeln.de
004922147885663
Time Frame
Start Date: 2023-08-04
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 60
Treatments
No_intervention: Standard care
After delivery the infant will be separated from the mother and placed on a primary care unit in another room to monitor the cardiopulmonary adaption for at least 20 minutes.
Experimental: skin-to-skin contact
After delivery the infant will be put skin-to-skin on the mother's breast in comfort position for 60 minutes. The cardiopulmonary adaption will be monitored and supervised by the attending neonatologist and nurse.
Related Therapeutic Areas
Sponsors
Leads: University of Cologne