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Delivery Room Skin-to-skin Study

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.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01959737
Acronym
deisy
Enrollment
88
Registered
2013-10-10
Start date
2013-10-31
Completion date
2016-01-31
Last updated
2018-06-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mother Child Interaction, Preterm Infant, Very Low Birthweight Infants

Keywords

reactivity of HPA axis

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.

Interventions

PROCEDUREskin-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.

Sponsors

University of Cologne
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
10 Minutes to 60 Minutes
Healthy volunteers
No

Inclusion criteria

* Birthweight \<1500g, first child, informed consent

Exclusion criteria

* Multiples, malformation

Design outcomes

Primary

MeasureTime frameDescription
Maternal sensitivity and responsiveness4 to 6 moinths corrected ageMaternal 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

MeasureTime frameDescription
Reactivity of HPA-axis36 to 40 weeks corrected ageSalivary cortisol assessment before and 20 minutes after heel lance
Molecular characterization of stress signaling pathways36 to 40 weeks corrected ageGenomic 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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026