NCT05975203

Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Cologne · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

The planned study investigates prospectively the effect of early intervention (skin-to-skin contact in the delivery room) in moderate and late preterm infants on neonatal programming by determining gene expression in the stress signaling pathway. The working hypothesis of our project is that the intervention will affect gene expression in a way that subsequently leads to better long-term psycho-social and neurological development of these preterm infants. The study aims to improve the understanding of the correlation of behavioral and epigenetic parameters and prove the underlying hypothesis of a novel mechanistic link between immediate skin-to-skin contact in the delivery room and life-long stress tolerance.

Conditions

• Preterm Birth
• Mother-Infant Interaction
• Infant Development

Interventions

Type	Name	Description
PROCEDURE	skin-to-skin contact	Immediately after delivery the infant will receive skin-to-skin contact with the mother.

Timeline

• Start date: 2023-08-04
• Primary completion: 2026-12-31
• Completion: 2028-12-31
• First posted: 2023-08-03
• Last updated: 2026-02-20

Locations

1 site across 1 country: Germany