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

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

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.

Study Overview

• Status: Unknown
• Conditions: Premature Infant
• Intervention / Treatment: Diagnostic test: Attachment story completion taks (ASCT)

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.

• Study Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: Katrin Mehler, MD; Phone Number: 00492214785998; Email: Katrin.Mehler@uk-koeln.de
• Study Contact Backup: Name: Angela Kribs, MD; Phone Number: 004922147885665; Email: Angela.Kribs@uk-koeln.de

Study Locations

• Germany
  • Cologne, Germany, 50937
    • Recruiting
    • University of Cologne, Medical Faculty
    • Contact: Katrin Mehler, MD; Phone Number: 00492214785998; Email: Katrin.Mehler@uk-koeln.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 9 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Former preterm infants and full-term infants at 6 to 8 years of age

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Fullterm infants; Quality of bonding is assessed at 6 to 8 years of age using the attachment story completion task. Infants are recruited from the local elementary school.	Diagnostic test: Attachment story completion taks (ASCT); Bonding quality; Other Names: Gene expression; Self-reporting questionnaires
Moderate to late preterm infants; Bonding quality is assessed at 6 to 8 years of age using the attachment story completion task. Infants are recruited from former participants of the "trauma and depression in late preterm parents study" (TraDelPP) conducted 2010 to 2011.	Diagnostic test: Attachment story completion taks (ASCT); Bonding quality; Other Names: Gene expression; Self-reporting questionnaires
Preterm infants with skin to skin contact; Bonding quality is assessed at 6 to 8 years of age using the attachment story completion task. Infants are recruited from former participants of the "delivery room skin to skin study" (deisy) who were randomized into the skin to skin contact group. The study was conducted from 2012 to 2015.	Diagnostic test: Attachment story completion taks (ASCT); Bonding quality; Other Names: Gene expression; Self-reporting questionnaires
Preterm infants with visual contact; Bonding quality is assessed at 6 to 8 years of age using the attachment story completion task. Infants are recruited from former participants of the "delivery room skin to skin study" (deisy) who were randomized into the visual contact group. The study was conducted from 2012 to 2015.	Diagnostic test: Attachment story completion taks (ASCT); Bonding quality; Other Names: Gene expression; Self-reporting questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Gene expression	Quantification of gene expression of six key molecules involved in stress response and neurobehavioural development	6 to 8 years of age

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Infant behavior	For assessment of infant behavior the German version of the Child Behavior Checklist (CBCL) is used.	6 to 8 years of age

Collaborators and Investigators

• Sponsor: University of Cologne

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2018
• Primary Completion (Anticipated): April 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: November 27, 2017
• First Submitted That Met QC Criteria: December 7, 2017
• First Posted (Actual): December 8, 2017

Study Record Updates

• Last Update Posted (Actual): November 20, 2020
• Last Update Submitted That Met QC Criteria: November 19, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Neurodevelopment; Gene expression; Bonding; Stress response
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: 17-075

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No