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

NCT ID: NCT03366285

Last Updated: 2020-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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.

Conditions

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Premature Infant

Keywords

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Bonding Gene expression Stress response Neurodevelopment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Attachment story completion taks (ASCT)

Intervention Type DIAGNOSTIC_TEST

Bonding quality

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.

Attachment story completion taks (ASCT)

Intervention Type DIAGNOSTIC_TEST

Bonding quality

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.

Attachment story completion taks (ASCT)

Intervention Type DIAGNOSTIC_TEST

Bonding quality

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.

Attachment story completion taks (ASCT)

Intervention Type DIAGNOSTIC_TEST

Bonding quality

Interventions

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Attachment story completion taks (ASCT)

Bonding quality

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Gene expression Self-reporting questionnaires

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Katrin Mehler

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Cologne, Medical Faculty

Cologne, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Katrin Mehler, MD

Role: CONTACT

Phone: 00492214785998

Email: [email protected]

Angela Kribs, MD

Role: CONTACT

Phone: 004922147885665

Email: [email protected]

Facility Contacts

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Katrin Mehler, MD

Role: primary

References

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Trautmann-Villalba P, Heine E, Kribs A, Mehler K. Does early skin-to-skin contact have a long-term effect on the emotional and behavioral development of very preterm infants? Front Psychol. 2024 Nov 11;15:1484419. doi: 10.3389/fpsyg.2024.1484419. eCollection 2024.

Reference Type DERIVED
PMID: 39588126 (View on PubMed)

Other Identifiers

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17-075

Identifier Type: -

Identifier Source: org_study_id