Clinical trial NCT03926923: Analysis of Mother-child Interaction and Regulation of Candidate Genes of Stress Signaling Pathways in Mature Infants
Official title: Analysis of Mother-child Interaction as Well as Expression and Methylation of Candidate Genes of Stress Signaling Pathways in Mature Infants
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mother-Child Interaction
Keywords: stress response
neurodevelopment
newborn
Lead sponsor: University of Cologne
Sponsor class: OTHER
First posted: 2019-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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).

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.

Detailed description: A separation of mother and child after birth can influence the quality of mother-child interaction and the regulation of stress signaling pathways. Maternal depression, parental stress and socioeconomic status can also affect the quality of mother-child interaction.

A former controlled randomized delivery room skin-to-skin study (deisy) showed, that skin contact of preterm infants and their mothers after birth improves the mother-child interaction. It also leads to a differential expression of candidate genes of the stress signaling pathways, which suggests a long term effect on mechanisms in stress response. The study group should now be compared to a group of mature infants with a normal, uninterrupted postnatal course.

The hypothesis is that the intervention in the deisy study (early skin-to-skin contact of preterm infants and their mothers) improves the mother-child interaction so that it is nearly comparable to mature infants with uninterrupted mother-child contact after birth. Furthermore it is assumed that the expression and methylation of candidate genes of the stress signaling pathways will be influenced by the intervention in the same way.

The mother-child interaction will be evaluated at the age of six months with a standardized method (Mannheim Rating Scales). Questionnaires about maternal depression, social support, socio-economic status, parental stress and mother-child relationship disorders as well as samples for the molecular genetic testing will be collected on the third day of life and at the age of six months. For the molecular genetic testing one blood sample and buccal swabs will be taken. The blood sample will not be done additionally but with a routine blood sampling on the third day of life (screening of inborn errors of metabolism).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Analysis of the mother-child interaction of mature infants at the age of six months
timeFrame: at the age of six months
Secondary outcomes:
measure: 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)
timeFrame: third day of life and age of six months
measure: Maternal depression
timeFrame: third day of life and age of six months
measure: Social support
timeFrame: third day of life and age of six months
measure: socio-economic status
timeFrame: third day of life and age of six months
measure: parental stress
timeFrame: third day of life and age of six months
measure: Parental Bonding
timeFrame: third day of life and age of six months
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University hospital of Cologne, Department of Neonatology
Study officials:
affiliation: University of Cologne
name: Katrin Mehler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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