Delivery Room Skin-to-skin Study

Not Applicable

Completed

• Conditions: Very Low Birthweight Infants; Mother Child Interaction; Preterm Infant
• Interventions: Procedure: skin-to.skin-contact

• Registration Number: NCT01959737
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-07
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-10
• Primary Completion: 2015-07
• Study Completion: 2016-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-24
• Last Update Posted: 2018-06-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• Birthweight <1500g, first child, informed consent

Exclusion Criteria

• Multiples, malformation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
skin-to-skin contact	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.

Primary Outcome Measures

Name	Time	Method
Maternal sensitivity and responsiveness	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

Name	Time	Method
Reactivity of HPA-axis	36 to 40 weeks corrected age	Salivary cortisol assessment before and 20 minutes after heel lance
Molecular characterization of stress signaling pathways	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

Trial Locations

Locations (1)

University hospital of Cologne, Department of Neonatology; 🇩🇪 Cologne, Germany