Delivery Room Skin-to-skin Study (deisy)

• ClinicalTrials.gov Identifier: NCT01959737
• Recruitment Status: Completed
• First Posted: October 10, 2013
• Last Update Posted: June 26, 2018
• Sponsor: University of Cologne
• Information provided by (Responsible Party): Katrin Mehler, University of Cologne

Study Description

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

Germany

University hospital of Cologne, Department of Neonatology

Cologne, Germany

Sponsors and Collaborators

University of Cologne

More Information

Publications:

Mehler K, Wendrich D, Kissgen R, Roth B, Oberthuer A, Pillekamp F, Kribs A. Mothers seeing their VLBW infants within 3 h after birth are more likely to establish a secure attachment behavior: evidence of a sensitive period with preterm infants? J Perinatol. 2011 Jun;31(6):404-10. doi: 10.1038/jp.2010.139. Epub 2010 Dec 9.

• Responsible Party: Katrin Mehler, MD, University of Cologne
• ClinicalTrials.gov Identifier: NCT01959737
• Other Study ID Numbers: 11-075
• First Posted: October 10, 2013
• 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:

Birth Weight; Body Weight