Delivery Room Skin-to-skin Study

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Very Low Birthweight Infants, Mother Child Interaction, Preterm Infant

Intervention / Treatment
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* Procedure: skin-to.skin-contact


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Birthweight <1500g, first child, informed consent Exclusion Criteria: Multiples, malformation

Ages Eligible for Study
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Minimum Age: 10 Minutes
Maximum Age: 60 Minutes

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: visual contact<br>After initial assessment/stabilization of the VLBW infant, visual contact of mother and infant is permitted for 5 minutes. | |
| Experimental: skin-to-skin contact<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reactivity of HPA-axis | Salivary cortisol assessment before and 20 minutes after heel lance | 36 to 40 weeks corrected age | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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reactivity of HPA axis