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

Sponsor
University of Cologne (Other)
Overall Status
Recruiting
CT.gov ID
NCT03366285
Collaborator
(none)
80
1
44
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Apr 1, 2018
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Dec 1, 2021

Arms and Interventions

Arm 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
  • Outcome Measures

    Primary Outcome Measures

    1. 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)

    2. Gene expression [6 to 8 years of age]

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

    Secondary Outcome Measures

    1. 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).

    2. 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).

    3. 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

    4. 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 infantĀ“s health)

    5. Infant behavior [6 to 8 years of age]

      For assessment of infant behavior the German version of the Child Behavior Checklist (CBCL) is used.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 9 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Cologne, Medical Faculty Cologne Germany 50937

    Sponsors and Collaborators

    • University of Cologne

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Katrin Mehler, MD, University of Cologne
    ClinicalTrials.gov Identifier:
    NCT03366285
    Other Study ID Numbers:
    • 17-075
    First Posted:
    Dec 8, 2017
    Last Update Posted:
    Nov 20, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Katrin Mehler, MD, University of Cologne
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 20, 2020