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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
Sponsor:
Information provided by (Responsible Party):
Katrin Mehler, University of Cologne

Brief Summary:
The first hours after birth are a sensitive period for promotion of optimal mother-child-interaction and secure attachment. Maternal sensitivity and responsivness are high in the first hours after birth due to high oxytocin levels. Developing optimal mother-child-interaction is more difficult for preterm mothers because mother and child are separated after birth and the preterm infant is not able to show strong signs to promote maternal sensitivity. We hypothesize that promoting skin-to-skin contact of VLBW infants and their mothers for 60 minutes within the first hours after birth improves mother-child-interaction at 5 to 6 months corrected age. We also hypothesize that reactivity of HPA axis and molecular patterns of stress signaling pathways differ in preterm infant with or without SSC after birth.

Condition or disease Intervention/treatment Phase
Very Low Birthweight Infants Mother Child Interaction Preterm Infant Procedure: skin-to.skin-contact Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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.
Procedure: skin-to.skin-contact
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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Reactivity of HPA-axis [ Time Frame: 36 to 40 weeks corrected age ]
    Salivary cortisol assessment before and 20 minutes after heel lance

  2. 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



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Ages Eligible for Study:   10 Minutes to 60 Minutes   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Birthweight <1500g, first child, informed consent

Exclusion Criteria:

  • Multiples, malformation

Information from the National Library of Medicine

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


Locations
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Germany
University hospital of Cologne, Department of Neonatology
Cologne, Germany
Sponsors and Collaborators
University of Cologne
Publications:
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Responsible Party: Katrin Mehler, MD, University of Cologne
ClinicalTrials.gov Identifier: NCT01959737    
Other Study ID Numbers: 11-075
First Posted: October 10, 2013    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Keywords provided by Katrin Mehler, University of Cologne:
reactivity of HPA axis
Additional relevant MeSH terms:
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Birth Weight
Body Weight