Delivery Room Skin-to-skin Study (deisy)
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|ClinicalTrials.gov Identifier: NCT01959737|
Recruitment Status : Completed
First Posted : October 10, 2013
Last Update Posted : June 26, 2018
|Condition or disease||Intervention/treatment||Phase|
|Very Low Birthweight Infants Mother Child Interaction Preterm Infant||Procedure: skin-to.skin-contact||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Influence of Early SSC of Mothers and Their VLBW Infants on Maternal Sensitivity and Responsiveness, Attachment Patterns and Reactivity of HPA Axis. Molecular Characterization of SSC Influence on Stress Signaling Pathways.|
|Actual Study Start Date :||October 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||January 2016|
No Intervention: visual contact
After initial assessment/stabilization of the VLBW infant, visual contact of mother and infant is permitted for 5 minutes.
Experimental: skin-to-skin contact
After initial stabilization mother and preterm infant are cared for skin-to-skin for 60 minuter. SSC is supervised by the attending neonatologist.
Immediately after initial stabilization/ assessment of the VLBW infant, skin-to-skin contact of mother and infant is initiated and kept up for 60 minutes.
- Maternal sensitivity and responsiveness [ Time Frame: 4 to 6 moinths corrected age ]Maternal sensitivity and responsiveness are assessed with the "Mannheimer Method" for the analysis of mother child interaction. At the infants corrected age of 4 to 6 months a videotape of the mother changing the infants diapers and playing with the infant is used for analysis.
- Reactivity of HPA-axis [ Time Frame: 36 to 40 weeks corrected age ]Salivary cortisol assessment before and 20 minutes after heel lance
- Molecular characterization of stress signaling pathways [ Time Frame: 36 to 40 weeks corrected age ]Genomic expression of the Glucocorticoid receptor (NR3C1), Corticotropin releasing hormon (CRH), Corticotropin releasing hormon receptor 1 (CRHR1), serotonin receptor 1A and 2A, serotonin transporter (slc6a4), vasopressin
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01959737
|University hospital of Cologne, Department of Neonatology|