Official Title
Effects of Contact Restrictions During the COVID-19 Pandemic on Newborns and Their Parents in Terms of Mother-infant Interaction, Parental Well-being, Expression and Methylation of Candidate Genes of Stress Signaling Pathways
Brief Summary

In the study, the researchers aim to investigate the impact of contact restrictions during the pandemic of coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on newborns and their parents. At the onset of this COVID-19 pandemic, contact restrictions in Germany were introduced on March 16th, 2020. These included, among others, the ban on visits to hospitals. This also applied to visits by fathers of newborn children. In many hospitals, fathers were allowed to accompany the mother in the delivery room for birth, but had to leave the hospital before the mother was being transferred to the ward. Fathers were not allowed to visit their wives and newborns until discharge several days later. The hypothesis of this study is that these contact restrictions have an influence on mother-infant interaction as well as on the psychological well-being of the parents. Furthermore, the investigators postulate that these restrictions additionally have a long-term effect on neonatal stress signaling pathways. For this purpose, children are studied, who were born during the period of strict contact restrictions from March, 16th to April, 30th, 2020. The children will be assessed at about six months of age.

Detailed Description

Due to the COVID-19 pandemic in spring 2020, the German government decided to impose strict
contact restrictions to prevent an exponential increase in SARS-CoV-2-positive individuals.
These included visiting regulations in hospitals from March 16th, 2020. These also applied to
obstetrics departments in Cologne until April 30th, 2020. At the Obstetrics University
Hospital Cologne as well as at the Protestant Hospital Cologne-Weyertal, fathers were allowed
to be present in the delivery room for the birth of their newborns, but had to leave the
hospital again before the mothers were being transferred to the obstetrics ward. The fathers
could not see their newborn again until they were discharged a few days later. The
consequences of these contact restrictions on the newborns and their parents have been little
studied.

In a few hospitals, there were exceptions currently to the strict contact restrictions. These
included the Hospital of the Augustinian Sisters in Cologne, where no visitation bans were
imposed on fathers in the obstetrics department. With general precautions fathers were still
allowed to accompany their newborns and mothers in the obstetric ward. The study of the
newborns of this hospital enables the researchers to see whether the parents were
nevertheless affected by the general changes in the living situation during a pandemic.

The phenomenon of "neonatal programming", which establishes the connection between formative
influences in the neonatal period (e.g. pain or stress by separation of mothers) and
disorders in later life (attention deficits, lack of concentration, learning difficulties)
has received increasing attention in recent years. In particular, the search for molecular
mechanisms that cause such programming has been the focus of scientific projects. In a
delivery-room skin-to-skin study (deisy) conducted by this research group preterm infants
were randomized to skin-to-skin contact or visual contact with their mothers. Significant
differences were found in both mother-infant interaction at six months of age and the
expression of candidate genes of stress signaling pathway.

An important regulatory mechanism for influencing the activity of certain genes in the long
term is the methylation of their promoter region. This epigenetic regulatory mechanism plays
an important role, so that the modulation of DNA methylation by events in the neonatal period
could be responsible for a permanent determination of a certain infant phenotype. This
methylation in candidate genes in the stress signaling pathway is currently investigated by
the research team in healthy mature neonates born before the onset of the pandemic, and
results are pending.

The aim of the present study is to investigate the impact of contact restrictions during the
coronavirus pandemic on newborns and their parents.

Normally in healthy mother-infant-dyads without separation during the first postpartal hours,
the mother has the best conditions to develop a high level of sensitivity. Sensitive maternal
behavior favors the formation of optimal mother-infant interaction and is relevant for infant
neurocognitive development. Due to the stressful situation caused by the separation of the
father for several days, the psychological well-being of the parents as well as the optimal
mother-child interaction could be negatively affected.

Completed
Mother-Child Interaction

Other: no intervention

There will be no intervention.

Eligibility Criteria

Inclusion Criteria:

- birth from March, 16th, 2020 to April, 30th, 2020 with with subsequent stay for at
least 48 hours in the obstetrics wards of the University Hospital of Cologne, the
obstetrics department of the protestant hospital Köln-Weyertal or Hospital of
Augustinian Sister's of Cologne

- mature newborn (38+0 to 41+6 weeks of gestational age)

- first child

- no separation of mother and child after birth

- informed consent

- good german language skills

Exclusion Criteria:

- multiples

- malformations or syndromes in the infant, reanimation after birth

- maternal psychological or severe physical illness

Eligibility Gender
All
Eligibility Age
Minimum: 6 Months ~ Maximum: 9 Months
Countries
Germany
Locations

University hospital of Cologne, Department of Neonatology
Cologne, Northrhine-westfalia, Germany

University of Cologne
NCT Number
Keywords
stress response
neurodevelopment
newborn
SARS-CoV-2
MeSH Terms
COVID-19