Clinical trial NCT03366285: Bonding Quality and Gene Expression in Fullterm Infants Compared to Late Preterm Infants and Preterm Infants With Early Skin to Skin or Visual Contact
Official title: 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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Premature Infant
Keywords: Bonding
Gene expression
Stress response
Neurodevelopment
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2017-12-08
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Former preterm infants and full-term infants at 6 to 8 years of age

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.

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

Primary outcomes:
measure: Bonding quality
timeFrame: 6 to 8 years of age
measure: Gene expression
timeFrame: 6 to 8 years of age
Secondary outcomes:
measure: Maternal depression
timeFrame: 6 to 8 years of age
measure: Maternal perceived social support
timeFrame: 6 to 8 years of age
measure: Maternal parenting stress
timeFrame: 6 to 8 years of age
measure: Infant health and development
timeFrame: 6 to 8 years of age
measure: Infant behavior
timeFrame: 6 to 8 years of age
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University of Cologne, Medical Faculty
Study officials:
References: