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NCT03926923

Analysis of Mother-child Interaction and Regulation of Candidate Genes of Stress Signaling Pathways in Mature Infants

Completed Last updated 14 July 2023
What this trial tests

trial testing no intervention in Mother-Child Interaction in 100 participants. Completed in 30 December 2020.

Timeline
18 July 2019
Primary endpoint
30 May 2020
30 December 2020

Quick facts

Lead sponsorUniversity of Cologne
StatusCompleted
Study typeOBSERVATIONAL
Enrollment100
Start date18 July 2019
Primary completion30 May 2020
Estimated completion30 December 2020
Sites1 location across Germany

Drugs / interventions tested

Conditions studied

Sponsor

University of Cologne

Who can join

Adults 1 Day to 3 Days, any sex, with Mother-Child Interaction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The planned study will investigate the quality of mother-child interaction at the age of 6 months as well as the expression and methylation of candidate genes of stress signaling pathway in mature infants. At best, mother and the healthy, term newborn are undisturbed after birth. This creates optimal conditions for the development of a good mother-child interaction. The results of the mother-child interaction and the molecular genetic investigations will be compared to the results of the randomized controlled delivery room skin-to-skin study (deisy, clinicaltrial.gov identifier: NCT 01959737). This study showed a significant difference in the mother-child interaction and expression of candidate genes in preterm infants with or without skin-to-skin contact after birth. The investigators hypothesize that the quality of mother-child interaction at the age of six months will be better in term newborns without postpartal separation of mother and child than in preterm infants with or without skin contact after birth. The second hypothesis is that there will be a difference in the expression and methylation of candidate genes of stress signaling pathway in these infants.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Does early skin-to-skin contact have a long-term effect on the emotional and behavioral development of very preterm infants?
    Trautmann-Villalba P, Heine E, Kribs A, Mehler K. · · 2024 · PMID 39588126 · DOI 10.3389/fpsyg.2024.1484419

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