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

NCT03926923 | Completed

• 1 other identifier: 19-1118
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mother-Child Interaction

Keywords

stress response; neurodevelopment; newborn

Outcome Measures

Primary Outcomes (1)

• Analysis of the mother-child interaction of mature infants at the age of six months

  Mother-child interaction is investigated at the age of six months using Mannheim Rating Scales. Therefore a four-minute-videotape of the mother changing the infant's diapers and playing with the infant is used. Mannheim Rating Scales is a good validated standardized observation instrument. Stimulation and response from the mother as well from the infant are being recorded. Different communication channels can be used by mother and child (vocal, facial or motor). All behaviors are analysed at intervals of five seconds (event coding). Then the values are formed from the sum of the coded events. The scale ranges from 0 to 48. If there is no interaction, the scale is 0. If there is an interaction in each interval (every 5 seconds in a 4 minute videotape), the scale is 48. The mother-child interaction is better if the scale is higher.

  at the age of six months

Secondary Outcomes (6)

• Analysis of expression and methylation of candidate genes of stress signaling pathways from infant blood (on the third day of life) as well as mucosal epithelial cells (buccal swab on the third day of life and at the age of six months)

  third day of life and age of six months

• Maternal depression

  third day of life and age of six months

• Social support

  third day of life and age of six months

• socio-economic status

  third day of life and age of six months

• parental stress

  third day of life and age of six months

Interventions

no intervention OTHER

There will be no intervention. The blood sample is taken while a routine blood sampling.

Eligibility Criteria

• Age: 1 Day - 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

The study population consits of healthy mature newborns who are not seperated from the mothers for three hours after birth. The recruitment will take place in three obstetric hospitals in Cologne (University Hospital of Cologne, Krankenhaus der Augustinnerinnen, evangelisches Krankenhaus Köln-Weyertal).

You may qualify if:

• mature newborn (38 to 41 weeks of gestational age)
• first child
• no separation of mother and child for three hours after birth
• informed consent

You may not qualify if:

• multiples
• malformations or syndromes in the infant
• maternal psychological or severe physical illness

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University hospital of Cologne, Department of Neonatology

Cologne, Germany

Location

Related Publications (2)

• Mehler, K.; Hucklenbruch-Rother, E.; Trautmann-Villalba, P.; Keller, T.; Becker, I.; Kribs, A. (2018): Early skin-to-skin contact in preterm infants is safe and improves quality of mother-child interaction. Abstracts der 44. Jahrestagung der Gesellschaft für Neonatologie und Pädiatrische Intensivmedizin (GNPI) In: Monatsschr Kinderheilkd (166), S. S54.

  BACKGROUND

• Hucklenbruch-Rother, E.; Mehler, K.; Keller, T.; Vohlen, C.; Mehdiani, N.; Kribs, A. (2018): Early skin-to-skin-contact affects stress response gene expression at hospital discharge. Abstracts der 44. Jahrestagung der Gesellschaft für Neonatologie und Pädiatrische Intensivmedizin (GNPI) In: Monatsschr Kinderheilkd (166), S. S54-S55

  BACKGROUND

Related Links

• deisy study results - improvement of mother-child interaction
• deisy study results - effect on stress response gene expression

Biospecimen

Retention: SAMPLES WITH DNA

* 500µl whole blood sample for RNA extraction in peripheral white blood cells * 2 buccal swabs with mucosal epithelial cells for RNA and DNA extraction

MeSH Terms

Conditions

Fractures, Stress

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries

Study Officials

• Katrin Mehler, MD

  University of Cologne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: adjunct professor, medical doctor Katrin Mehler

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 25, 2019
• Study Start: July 18, 2019
• Primary Completion: May 30, 2020
• Study Completion: December 30, 2020
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)