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

• Conditions: Premature Infant
• Interventions: Diagnostic Test: Attachment story completion taks (ASCT)

• Registration Number: NCT03366285
• Lead Sponsor: University of Cologne

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.

Study Timeline

• Study First Submitted: 2017-11-27
• Study First Submitted QC: 2017-12-07
• Study First Posted: 2017-12-08
• Study Start: 2018-04-01
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-19
• Last Update Posted: 2020-11-20
• Primary Completion: 2021-04
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Moderate to late preterm infants	Attachment story completion taks (ASCT)	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.
Preterm infants with skin to skin contact	Attachment story completion taks (ASCT)	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.
Preterm infants with visual contact	Attachment story completion taks (ASCT)	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.
Fullterm infants	Attachment story completion taks (ASCT)	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.

Primary Outcome Measures

Name	Time	Method
Gene expression	6 to 8 years of age	Quantification of gene expression of six key molecules involved in stress response and neurobehavioural development
Bonding quality	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 Outcome Measures

Name	Time	Method
Maternal parenting stress	6 to 8 years of age	For the assessment of parenting stress the German version of the Parenting Stress Index (PSI) is used
Maternal depression	6 to 8 years of age	Maternal depression is assessed with the German long form of the Center for Epidemiological Studies Depression Scale (CES-D).
Maternal perceived social support	6 to 8 years of age	Perceived social support is assessed with the short version of the F-SozU scale (F-SozU K-22).
Infant health and development	6 to 8 years of age	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)
Infant behavior	6 to 8 years of age	For assessment of infant behavior the German version of the Child Behavior Checklist (CBCL) is used.

Trial Locations

Locations (1)

University of Cologne, Medical Faculty; 🇩🇪 Cologne, Germany