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

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ClinicalTrials.gov Identifier: NCT03926923
Recruitment Status : Active, not recruiting
First Posted : April 25, 2019
Last Update Posted : August 31, 2020
Sponsor:
Information provided by (Responsible Party):
Katrin Mehler, University of Cologne

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.


Condition or disease Intervention/treatment
Mother-Child Interaction Other: no intervention

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).

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Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Analysis of Mother-child Interaction as Well as Expression and Methylation of Candidate Genes of Stress Signaling Pathways in Mature Infants
Actual Study Start Date : July 18, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Other: no intervention
    There will be no intervention. The blood sample is taken while a routine blood sampling.


Primary Outcome Measures :
  1. Analysis of the mother-child interaction of mature infants at the age of six months [ Time Frame: 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.



Secondary Outcome Measures :
  1. 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) [ Time Frame: third day of life and age of six months ]
    RNA and DNA will be extracted from peripheral white blood cells and mucosal epithelial cells. The expression and methylation of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 (CRHR1), serotonin receptors (1A and 2A), serotonin transporter (slc6a4) and vasopressin.

  2. Maternal depression [ Time Frame: third day of life and age of six months ]
    Maternal depression is assessed with the German long form of the Center for Epidemiological Studies Depression Scale (CES-D). It is a self-report questionnaire to measure depressive symptoms and it consists of 20 questions. For each question the response choice are assigned point values (how often a symptom occurred during the last week). The point values are summed to a total measure score. The score ranges from 0 to 60. Zero points represents no symptoms of depression, a score of 15 or higher is interpreted to indicate a risk of depression.

  3. Social support [ Time Frame: third day of life and age of six months ]

    Social support is assessed with the short version of the F-SozU (Fragebogen zur sozialen Unterstützung, questionnaire on social support) scale (F-SozU K-22).

    The questionnaire records the subjectively perceived or anticipated support from the social environment. There are 22 items and the test person can indicate the degree of agreement on a five-level Likert scale (from 1 = does not apply to 5 = applies completely). The scale ranges from a minimum of 22 points to a maximum of 110 points. The higher the score, the better the subjectively perceived or anticipated support.


  4. socio-economic status [ Time Frame: third day of life and age of six months ]
    There will be a question to the household income per month and the mother's highest school-leaving certificate.

  5. parental stress [ Time Frame: third day of life and age of six months ]

    Parental stress is assessed with the German form of the parenting stress index (PSI).

    It consists of 48 items. The test person can indicate the degree of agreement on a five-level Likert scale (from 1 = does not apply to 5 = applies completely). There are 12 subscales, each consisting of 4 items and the points on the Likert scale are added. In each subscale there can be a minimum of 4 and a maximum of 20 points. The higher the score, the higher the parental stress.


  6. Parental Bonding [ Time Frame: third day of life and age of six months ]
    Parental Bonding is assessed with the parental bonding questionnaire (PBQ). It consists of 25 items and each item is rated on a scale from 0 to 3 points (response range from "very like" to "very unlike"). There are four subscales and the point values of each subscale are summed to a total measure score. The four subscales are: impaired bonding, rejection and anger, anxiety about care, risk of abuse. The higher the score, the higher the risk of a disorder in each area of the subscale.


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


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926923


Locations
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Germany
University hospital of Cologne, Department of Neonatology
Cologne, Germany
Sponsors and Collaborators
University of Cologne
Investigators
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Principal Investigator: Katrin Mehler, MD University of Cologne
Additional Information:
Publications:
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.
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

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Responsible Party: Katrin Mehler, adjunct professor, medical doctor Katrin Mehler, University of Cologne
ClinicalTrials.gov Identifier: NCT03926923    
Other Study ID Numbers: 19-1118
First Posted: April 25, 2019    Key Record Dates
Last Update Posted: August 31, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katrin Mehler, University of Cologne:
stress response
neurodevelopment
newborn