Mother-Child InteractionNCT03926923
Analysis of Mother-child Interaction and Regulation of Candidate Genes of Stress Signaling Pathways in Mature Infants
An observational study of Mother-Child Interaction, run by University of Cologne at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 3 days
- Conditions the study is for
- Mother-Child Interaction
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 18 Jul 2019to 30 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 3 days
- All sexes
- No healthy volunteers
- Child
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).
Who may be able to join
- mature newborn (38 to 41 weeks of gestational age)
- first child
- no separation of mother and child for three hours after birth
- informed consent
Who cannot join
- multiples
- malformations or syndromes in the infant
- maternal psychological or severe physical illness
Trial locations and contacts
1 site in 1 country.
Germany1 site
University hospital of Cologne, Department of Neonatology
Cologne
About this study
Official title: Analysis of Mother-child Interaction as Well as Expression and Methylation of Candidate Genes of Stress Signaling Pathways in Mature Infants
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.
Read the 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).
- Conditions
- Mother-Child Interaction
- Being tested
- no intervention
- Keywords
- stress response, neurodevelopment, newborn
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
There will be no intervention. The blood sample is taken while a routine blood sampling.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: third day of life and age of six months
Maternal depression
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.
Measured: third day of life and age of six months
Social support
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.
Measured: third day of life and age of six months
socio-economic status
There will be a question to the household income per month and the mother's highest school-leaving certificate.
Measured: third day of life and age of six months
parental stress
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.
Measured: third day of life and age of six months
Parental Bonding
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.
Measured: third day of life and age of six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2019
- Study start18 Jul 2019
- Primary completion30 May 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Mother-Child InteractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrin Mehler, University of Cologne
- Investigators
- Katrin Mehler, MD, Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926923
- Sponsor's protocol ID
- 19-1118
- Status last verified
- Jul 2023
- First submitted
- 2 Apr 2019
- Last updated
- 14 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Mother-child Interaction as Well as Expression and Methylation of Candidate Genes of Stress Signaling Pathways in Mature Infants
- ClinicalTrials.gov ID
- NCT03926923
- Acronym / sponsor ID
- 19-1118
- Conditions
- Mother-Child Interaction
- Keywords
- stress response, neurodevelopment, newborn
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 25 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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).
Key inclusion criteria (4 listed)
- mature newborn (38 to 41 weeks of gestational age)
- first child
- no separation of mother and child for three hours after birth
- informed consent
Key exclusion criteria (3 listed)
- multiples
- malformations or syndromes in the infant
- maternal psychological or severe physical illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventionThere will be no intervention. The blood sample is taken while a routine blood sampling. | Other | – |
Primary outcome
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.
6 secondary outcomes
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
Maternal depression
Time frame: third day of life and age of six months
Social support
Time frame: third day of life and age of six months
socio-economic status
Time frame: third day of life and age of six months
parental stress
Time frame: third day of life and age of six months
Parental Bonding
Time frame: third day of life and age of six months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2023.
- BackgroundMehler, 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.
- BackgroundHucklenbruch-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
- deisy study results - improvement of mother-child interactionLink provided by the sponsor.
- deisy study results - effect on stress response gene expressionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrin Mehler, MD principal investigator
University of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mother-Child Interaction, run by University of Cologne at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of the mother-child interaction of mature infants at the age of six months (time frame: at the age of six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03926923, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2023.