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Delivery Room Skin-to-skin Study (deisy)

Primary Purpose

Very Low Birthweight Infants, Mother Child Interaction, Preterm Infant

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
skin-to.skin-contact
Sponsored by
University of Cologne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Very Low Birthweight Infants focused on measuring reactivity of HPA axis

Eligibility Criteria

10 Minutes - 60 Minutes (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Birthweight <1500g, first child, informed consent

Exclusion Criteria:

  • Multiples, malformation

Sites / Locations

  • University hospital of Cologne, Department of Neonatology

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

visual contact

skin-to-skin contact

Arm Description

After initial assessment/stabilization of the VLBW infant, visual contact of mother and infant is permitted for 5 minutes.

After initial stabilization mother and preterm infant are cared for skin-to-skin for 60 minuter. SSC is supervised by the attending neonatologist.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Reactivity of HPA-axis
Salivary cortisol assessment before and 20 minutes after heel lance
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

Full Information

First Posted
October 7, 2013
Last Updated
June 24, 2018
Sponsor
University of Cologne
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1. Study Identification

Unique Protocol Identification Number
NCT01959737
Brief Title
Delivery Room Skin-to-skin Study
Acronym
deisy
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.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Cologne

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Very Low Birthweight Infants, Mother Child Interaction, Preterm Infant
Keywords
reactivity of HPA axis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
visual contact
Arm Type
No Intervention
Arm Description
After initial assessment/stabilization of the VLBW infant, visual contact of mother and infant is permitted for 5 minutes.
Arm Title
skin-to-skin contact
Arm Type
Experimental
Arm Description
After initial stabilization mother and preterm infant are cared for skin-to-skin for 60 minuter. SSC is supervised by the attending neonatologist.
Intervention Type
Procedure
Intervention Name(s)
skin-to.skin-contact
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maternal sensitivity and responsiveness
Description
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.
Time Frame
4 to 6 moinths corrected age
Secondary Outcome Measure Information:
Title
Reactivity of HPA-axis
Description
Salivary cortisol assessment before and 20 minutes after heel lance
Time Frame
36 to 40 weeks corrected age
Title
Molecular characterization of stress signaling pathways
Description
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
Time Frame
36 to 40 weeks corrected age

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Minutes
Maximum Age & Unit of Time
60 Minutes
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Birthweight <1500g, first child, informed consent Exclusion Criteria: Multiples, malformation
Facility Information:
Facility Name
University hospital of Cologne, Department of Neonatology
City
Cologne
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
21151007
Citation
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.
Results Reference
background

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Delivery Room Skin-to-skin Study

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