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

NCT03366285 | Unknown

• 1 other identifier: 17-075
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Infant

Keywords

Bonding; Gene expression; Stress response; Neurodevelopment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Maternal depression

  6 to 8 years of age

• Maternal perceived social support

  6 to 8 years of age

• Maternal parenting stress

  6 to 8 years of age

• Infant health and development

  6 to 8 years of age

• Infant behavior

  6 to 8 years of age

Study Arms (4)

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)

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)

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)

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)

Interventions

Attachment story completion taks (ASCT) DIAGNOSTIC_TEST

Bonding quality

Also known as: Gene expression, Self-reporting questionnaires

Fullterm infants; Moderate to late preterm infants; Preterm infants with skin to skin contact; Preterm infants with visual contact

Eligibility Criteria

• Age: 6 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• first child, singleton, former participant of "deisy" or "TraDelPP" study for preterm infants, uncomplicated vaginal birth for fullterm infants

You may not qualify if:

• Maternal mental health problems, resuscitation after birth, malformations or severe underlying disease

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University of Cologne, Medical Faculty

Cologne, 50937, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 39588126 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral white blood cells

MeSH Terms

Conditions

Premature Birth; Fractures, Stress

Interventions

Gene Expression

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Fractures, Bone; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Genetic Phenomena

Central Study Contacts

Katrin Mehler, MD

CONTACT

00492214785998; Katrin.Mehler@uk-koeln.de

Angela Kribs, MD

CONTACT

004922147885665; Angela.Kribs@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 27, 2017
• First Posted: December 8, 2017
• Study Start: April 1, 2018
• Primary Completion: April 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 20, 2020

Record last verified: 2020-11

Locations

DE (1)