Ignite Creation Date:
2025-12-24 @ 7:46 PM
Ignite Modification Date:
2025-12-25 @ 5:23 PM
Study NCT ID:
NCT05975203
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2023-07-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
Sponsor:
University of Cologne
Organization:
Study Overview
Official Title:
Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COSY
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.
* 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: