Delivery Room Skin-to-skin Study

Preterm Infant Clinical Trial

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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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01959737
• Other study ID #: 11-075
• Status: Completed
• Phase: N/A
• Start date: October 2013
• Est. completion date: January 2016

Study information

• Verified date: June 2018
• Source: University of Cologne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: January 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 60 Minutes

Eligibility

Inclusion Criteria:

• Birthweight <1500g, first child, informed consent

Exclusion Criteria:

• Multiples, malformation

Related Conditions & MeSH terms

• Birth Weight
• Mother Child Interaction
• Preterm Infant
• Very Low Birthweight Infants

Intervention

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.

Locations

Country	Name	City	State
Germany	University hospital of Cologne, Department of Neonatology	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal sensitivity and responsiveness	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.	4 to 6 moinths corrected age
Secondary	Reactivity of HPA-axis	Salivary cortisol assessment before and 20 minutes after heel lance	36 to 40 weeks corrected age
Secondary	Molecular characterization of stress signaling pathways	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	36 to 40 weeks corrected age