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

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ClinicalTrials.gov Identifier: NCT03366285
Recruitment Status : Not yet recruiting
First Posted : December 8, 2017
Last Update Posted : December 8, 2017
Sponsor:
Information provided by (Responsible Party):
Katrin Mehler, 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.

Condition or disease Intervention/treatment
Premature Infant 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.

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Study Type : Observational
Estimated 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
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Bonding quality [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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)

  5. Infant behavior [ Time Frame: 6 to 8 years of age ]
    For assessment of infant behavior the German version of the Child Behavior Checklist (CBCL) is used.


Biospecimen Retention:   Samples With DNA
Peripheral white blood cells


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Former preterm infants and full-term infants at 6 to 8 years of age
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03366285


Contacts
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Contact: Katrin Mehler, MD 00492214785998 Katrin.Mehler@uk-koeln.de
Contact: Angela Kribs, MD 004922147885665 Angela.Kribs@uk-koeln.de

Sponsors and Collaborators
University of Cologne

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Responsible Party: Katrin Mehler, MD, University of Cologne
ClinicalTrials.gov Identifier: NCT03366285     History of Changes
Other Study ID Numbers: 17-075
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: December 8, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Katrin Mehler, University of Cologne:
Bonding
Gene expression
Stress response
Neurodevelopment