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Clinical Trials/NCT03366285
NCT03366285
Unknown
Not Applicable

Bonding Quality and Gene Expression of Key Molecules Involved in Stress Response in Fullterm Infants Compared to Late Preterm Infants and Preterm Infants With Early Skin to Skin Contact or Visual Contact at Age 6 to 8 Years

University of Cologne1 site in 1 country80 target enrollmentApril 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Premature Infant
Sponsor
University of Cologne
Enrollment
80
Locations
1
Primary Endpoint
Gene expression
Last Updated
5 years ago

Overview

Brief Summary

Recent research has identified differences in the quality of mother-child interaction and gene expression of six key molecules involved in stress response and neurobehavioral development in preterm infants (born <32 weeks of gestational age) with early skin to skin contact after birth compared to infants with visual contact at six months corrected age. We hypothesize that these differences are still identifiable at the age of 6 to 8 years and that quality of bonding in preterm infants born <32 weeks of gestation differs significantly from late preterm infants and full-term infants.

Detailed Description

Quality of bonding in former preterm infants born 2012 to 2015 who participated in the "delivery room skin to skin study" (deisy), moderate to late preterm infants born 2010 to 2011 who participated in the "trauma and depression in late preterm parents study" (TraDelPP) and full-term infants at 6 to 8 years of age is assessed using the German version of the attachment story completion task (ASCT). Additionally, gene expression of six key molecules involved in stress response and neurobehavioral development (the corticotropin releasing hormone receptor 1 and 2 genes (CRHR1 and CRHR2), arginine vasopressin gene (AVP), the glucocorticoid receptor gene (NR3C1), the serotonin receptor 2A gene (HTR2A), and the serotonin transporter gene (SLC6A4)) are quantified in in mucosal epithelial cells from buccal swabs of children of all four groups. Maternal and infant co-factors such as maternal depression, perceived social support, parental stress, infant health development and behavior are assessed by self-reporting questionnaires.

Registry
clinicaltrials.gov
Start Date
April 1, 2018
End Date
December 2021
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Katrin Mehler

MD

University of Cologne

Eligibility Criteria

Inclusion Criteria

  • first child, singleton, former participant of "deisy" or "TraDelPP" study for preterm infants, uncomplicated vaginal birth for fullterm infants

Exclusion Criteria

  • Maternal mental health problems, resuscitation after birth, malformations or severe underlying disease

Outcomes

Primary Outcomes

Gene expression

Time Frame: 6 to 8 years of age

Quantification of gene expression of six key molecules involved in stress response and neurobehavioural development

Bonding quality

Time Frame: 6 to 8 years of age

Quality of mother infant bonding is assessed with the German version of the Attachment Story Completion Task (Bretherton and Ridgeway 1990)

Secondary Outcomes

  • Maternal parenting stress(6 to 8 years of age)
  • Maternal depression(6 to 8 years of age)
  • Maternal perceived social support(6 to 8 years of age)
  • Infant health and development(6 to 8 years of age)
  • Infant behavior(6 to 8 years of age)

Study Sites (1)

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