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

Condition(s) studied

Investigational drug(s) / intervention(s)

skin-to-skin contact: Immediately after delivery the infant will receive skin-to-skin contact with the mother.

Study 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

Primary outcome measure(s)

• gene expression in candidate genes of the stress signalling pathway — 36 to 72 hours after birth
  DNA will be extracted from peripheral white blood cells and mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.
• gene expression in candidate genes of the stress signalling pathway — corrected 6 months of age
  DNA and RNA will be extracted from mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor. Furthermore a whole-genome methylation will be analysed.
• gene expression in candidate genes of the stress signalling pathway — corrected 24 months of age
  DNA will be extracted from mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.

Trial sites (1)

More University of Cologne trials in Germany

Other trials for the same condition