Effects of Contact Restrictions During the COVID-19 Pandemic on Newborns and Their Parents

NCT04732702 | Completed

• 1 other identifier: 20-1440
• Study Type: observational
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Mother-Child Interaction

Keywords

stress response; neurodevelopment; newborn; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• Analysis of the mother-child-interaction

  Mother-child interaction is investigated at the age of about six months using Mannheim Rating Scales. Therefore a five-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 60. If there is no interaction, the scale is 0. If there is an interaction in each interval (every 5 seconds in a 5 minute videotape), the scale is 60. The mother-child interaction is better if the scale is higher.

  at the age of six to nine months

Secondary Outcomes (7)

• Analysis of expression and methylation of candidate genes of stress signaling pathways from mucosal epithelial cells (buccal swab)

  at the age of six to nine months

• parental depression

  at the infant's age of six to nine months

• parental subjective distress caused by traumatic events

  at the infant's age of six to nine months

• Social support

  at the infant's age of six to nine months

• parental stress

  at the infant's age of six to nine months

Interventions

no intervention OTHER

There will be no intervention.

Eligibility Criteria

• Age: 6 Months - 9 Months
• 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 were born during the time of strict contact restrictions from March, 16th to April, 30th, 2020. 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:

• 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

You may not qualify if:

• multiples
• malformations or syndromes in the infant, reanimation after birth
• maternal psychological or severe physical illness

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University hospital of Cologne, Department of Neonatology

Cologne, Northrhine-westfalia, 50931, Germany

Location

Related Publications (2)

• Mehler K, Hucklenbruch-Rother E, Trautmann-Villalba P, Becker I, Roth B, Kribs A. Delivery room skin-to-skin contact for preterm infants-A randomized clinical trial. Acta Paediatr. 2020 Mar;109(3):518-526. doi: 10.1111/apa.14975. Epub 2019 Sep 16.

  PMID: 31423649 BACKGROUND

• Hucklenbruch-Rother E, Vohlen C, Mehdiani N, Keller T, Roth B, Kribs A, Mehler K. Delivery room skin-to-skin contact in preterm infants affects long-term expression of stress response genes. Psychoneuroendocrinology. 2020 Dec;122:104883. doi: 10.1016/j.psyneuen.2020.104883. Epub 2020 Sep 24.

  PMID: 33027708 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

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 Design

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

Study Record Dates

• First Submitted: January 28, 2021
• First Posted: February 1, 2021
• Study Start: October 29, 2020
• Primary Completion: January 31, 2021
• Study Completion: April 30, 2021
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)