Bonding Quality and Gene Expression in Fullterm Infants Compared to Late Preterm Infants and Preterm Infants With Early Skin to Skin or Visual Contact

Premature Infant Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03366285
• Other study ID #: 17-075
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: December 2021

Study information

• Verified date: November 2020
• Source: University of Cologne
• Contact: Katrin Mehler, MD
• Phone: 00492214785998
• Email: Katrin.Mehler[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2021
• Est. primary completion date: April 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 9 Years

Eligibility

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

Related Conditions & MeSH terms

• Premature Birth
• Premature Infant

Intervention

Diagnostic Test:
• Attachment story completion taks (ASCT)
Bonding quality

Locations

Country	Name	City	State
Germany	University of Cologne, Medical Faculty	Cologne

Sponsors (1)

Lead Sponsor	Collaborator
University of Cologne

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bonding quality	Quality of mother infant bonding is assessed with the German version of the Attachment Story Completion Task (Bretherton and Ridgeway 1990)	6 to 8 years of age
Primary	Gene expression	Quantification of gene expression of six key molecules involved in stress response and neurobehavioural development	6 to 8 years of age
Secondary	Maternal depression	Maternal depression is assessed with the German long form of the Center for Epidemiological Studies Depression Scale (CES-D).	6 to 8 years of age
Secondary	Maternal perceived social support	Perceived social support is assessed with the short version of the F-SozU scale (F-SozU K-22).	6 to 8 years of age
Secondary	Maternal parenting stress	For the assessment of parenting stress the German version of the Parenting Stress Index (PSI) is used	6 to 8 years of age
Secondary	Infant health and development	Infant health and development are assessed by a self-reporting questionnaire and the results from compulsory pediatric medical checkups. The questionnaire for assessment of infant health and development was designed for the KIGGS study (a large German cohort study on infant´s health)	6 to 8 years of age
Secondary	Infant behavior	For assessment of infant behavior the German version of the Child Behavior Checklist (CBCL) is used.	6 to 8 years of age