Premature InfantNCT03366285
Bonding Quality and Gene Expression in Fullterm Infants Compared to Late Preterm Infants and Preterm Infants With Early Skin to Skin or Visual Contact
An observational study of Premature Infant, run by University of Cologne at 1 site in Germany.
Trial summary
Recent research has identified differences in the quality of mother-child interaction and gene expression of six key molecules involved in stress response and neurobehavioral development in preterm infants (born <32 weeks of gestational age) with early skin to skin contact after birth compared to infants with visual… Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Premature Infant
- What is being tested?
- Attachment story completion taks (ASCT)
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- 1 Apr 2018to Dec 2021
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Study population: Former preterm infants and full-term infants at 6 to 8 years of age
Who may be able to join
- first child, singleton, former participant of "deisy" or "TraDelPP" study for preterm infants, uncomplicated vaginal birth for fullterm infants
Who cannot join
- Maternal mental health problems, resuscitation after birth, malformations or severe underlying disease
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University of Cologne, Medical Faculty
Cologne, 50937
Katrin Mehler, MD, 00492214785998, Katrin.Mehler@uk-koeln.de
About this study
Official title: Bonding Quality and Gene Expression of Key Molecules Involved in Stress Response in Fullterm Infants Compared to Late Preterm Infants and Preterm Infants With Early Skin to Skin Contact or Visual Contact at Age 6 to 8 Years
Recent research has identified differences in the quality of mother-child interaction and gene expression of six key molecules involved in stress response and neurobehavioral development in preterm infants (born <32 weeks of gestational age) with early skin to skin contact after birth compared to infants with visual contact at six months corrected age. We hypothesize that these differences are still identifiable at the age of 6 to 8 years and that quality of bonding in preterm infants born <32 weeks of gestation differs significantly from late preterm infants and full-term infants.
Read the detailed description
Quality of bonding in former preterm infants born 2012 to 2015 who participated in the "delivery room skin to skin study" (deisy), moderate to late preterm infants born 2010 to 2011 who participated in the "trauma and depression in late preterm parents study" (TraDelPP) and full-term infants at 6 to 8 years of age is assessed using the German version of the attachment story completion task (ASCT). Additionally, gene expression of six key molecules involved in stress response and neurobehavioral development (the corticotropin releasing hormone receptor 1 and 2 genes (CRHR1 and CRHR2), arginine vasopressin gene (AVP), the glucocorticoid receptor gene (NR3C1), the serotonin receptor 2A gene (HTR2A), and the serotonin transporter gene (SLC6A4)) are quantified in in mucosal epithelial cells from buccal swabs of children of all four groups. Maternal and infant co-factors such as maternal depression, perceived social support, parental stress, infant health development and behavior are assessed by self-reporting questionnaires.
- Conditions
- Premature Infant
- Being tested
- Attachment story completion taks (ASCT)
- Keywords
- Bonding, Gene expression, Stress response, Neurodevelopment
- Medical subject headings
- Premature Birth, Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Attachment story completion taks (ASCT)Diagnostic test
Also called Gene expression, Self-reporting questionnaires
Bonding quality
| Study group | Role | What they receive |
|---|---|---|
| Fullterm infants | Quality of bonding is assessed at 6 to 8 years of age using the attachment story completion task. Infants are recruited from the local elementary school. Receives: Diagnostic Test: Attachment story completion taks (ASCT) | |
| Moderate to late preterm infants | Bonding quality is assessed at 6 to 8 years of age using the attachment story completion task. Infants are recruited from former participants of the "trauma and depression in late preterm parents study" (TraDelPP) conducted 2010 to 2011. Receives: Diagnostic Test: Attachment story completion taks (ASCT) | |
| Preterm infants with skin to skin contact | Bonding quality is assessed at 6 to 8 years of age using the attachment story completion task. Infants are recruited from former participants of the "delivery room skin to skin study" (deisy) who were randomized into the skin to skin contact group. The study was conducted from 2012 to 2015. Receives: Diagnostic Test: Attachment story completion taks (ASCT) | |
| Preterm infants with visual contact | Bonding quality is assessed at 6 to 8 years of age using the attachment story completion task. Infants are recruited from former participants of the "delivery room skin to skin study" (deisy) who were randomized into the visual contact group. The study was conducted from 2012 to 2015. Receives: Diagnostic Test: Attachment story completion taks (ASCT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bonding quality
Quality of mother infant bonding is assessed with the German version of the Attachment Story Completion Task (Bretherton and Ridgeway 1990)
Measured: 6 to 8 years of age
Gene expression
Quantification of gene expression of six key molecules involved in stress response and neurobehavioural development
Measured: 6 to 8 years of age
Secondary outcomes (5)
Maternal depression
Maternal depression is assessed with the German long form of the Center for Epidemiological Studies Depression Scale (CES-D).
Measured: 6 to 8 years of age
Maternal perceived social support
Perceived social support is assessed with the short version of the F-SozU scale (F-SozU K-22).
Measured: 6 to 8 years of age
Maternal parenting stress
For the assessment of parenting stress the German version of the Parenting Stress Index (PSI) is used
Measured: 6 to 8 years of age
Infant health and development
Infant health and development are assessed by a self-reporting questionnaire and the results from compulsory pediatric medical checkups. The questionnaire for assessment of infant health and development was designed for the KIGGS study (a large German cohort study on infant´s health)
Measured: 6 to 8 years of age
Infant behavior
For assessment of infant behavior the German version of the Child Behavior Checklist (CBCL) is used.
Measured: 6 to 8 years of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2017
- Study start1 Apr 2018
- Primary completionApr 2021 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premature InfantStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrin Mehler, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03366285
- Sponsor's protocol ID
- 17-075
- Status last verified
- Nov 2020
- First submitted
- 27 Nov 2017
- Last updated
- 20 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Trautmann-Villalba P, Heine E, Kribs A, Mehler K. Does early skin-to-skin contact have a long-term effect on the emotional and behavioral development of very preterm infants? Front Psychol. 2024 Nov 11;15:1484419. doi: 10.3389/fpsyg.2024.1484419. eCollection 2024.
PubMed 39588126
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bonding Quality and Gene Expression of Key Molecules Involved in Stress Response in Fullterm Infants Compared to Late Preterm Infants and Preterm Infants With Early Skin to Skin Contact or Visual Contact at Age 6 to 8 Years
- ClinicalTrials.gov ID
- NCT03366285
- Acronym / sponsor ID
- 17-075
- Conditions
- Premature Infant
- Keywords
- Bonding, Gene expression, Stress response, Neurodevelopment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Apr 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 8 Dec 2017 (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.
Recent research has identified differences in the quality of mother-child interaction and gene expression of six key molecules involved in stress response and neurobehavioral development in preterm infants (born <32 weeks of gestational age) with early skin to skin contact after birth compared to infants with visual contact at six months corrected age. We hypothesize that these differences are still identifiable at the age of 6 to 8 years and that quality of bonding in preterm infants born <32 weeks of gestation differs significantly from late preterm infants and full-term infants.
Detailed description
Quality of bonding in former preterm infants born 2012 to 2015 who participated in the "delivery room skin to skin study" (deisy), moderate to late preterm infants born 2010 to 2011 who participated in the "trauma and depression in late preterm parents study" (TraDelPP) and full-term infants at 6 to 8 years of age is assessed using the German version of the attachment story completion task (ASCT). Additionally, gene expression of six key molecules involved in stress response and neurobehavioral development (the corticotropin releasing hormone receptor 1 and 2 genes (CRHR1 and CRHR2), arginine vasopressin gene (AVP), the glucocorticoid receptor gene (NR3C1), the serotonin receptor 2A gene (HTR2A), and the serotonin transporter gene (SLC6A4)) are quantified in in mucosal epithelial cells from buccal swabs of children of all four groups. Maternal and infant co-factors such as maternal depression, perceived social support, parental stress, infant health development and behavior are assessed by self-reporting questionnaires.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Fullterm infants | – | Diagnostic Test: Attachment story completion taks (ASCT)Quality of bonding is assessed at 6 to 8 years of age using the attachment story completion task. Infants are recruited from the local elementary school. |
| Moderate to late preterm infants | – | Diagnostic Test: Attachment story completion taks (ASCT)Bonding quality is assessed at 6 to 8 years of age using the attachment story completion task. Infants are recruited from former participants of the "trauma and depression in late preterm parents study" (TraDelPP) conducted 2010 to 2011. |
| Preterm infants with skin to skin contact | – | Diagnostic Test: Attachment story completion taks (ASCT)Bonding quality is assessed at 6 to 8 years of age using the attachment story completion task. Infants are recruited from former participants of the "delivery room skin to skin study" (deisy) who were randomized into the skin to skin contact group. The study was conducted from 2012 to 2015. |
| Preterm infants with visual contact | – | Diagnostic Test: Attachment story completion taks (ASCT)Bonding quality is assessed at 6 to 8 years of age using the attachment story completion task. Infants are recruited from former participants of the "delivery room skin to skin study" (deisy) who were randomized into the visual contact group. The study was conducted from 2012 to 2015. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Former preterm infants and full-term infants at 6 to 8 years of age
Key inclusion criteria (1 listed)
- first child, singleton, former participant of "deisy" or "TraDelPP" study for preterm infants, uncomplicated vaginal birth for fullterm infants
Key exclusion criteria (1 listed)
- Maternal mental health problems, resuscitation after birth, malformations or severe underlying disease
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 |
|---|---|---|
| Attachment story completion taks (ASCT)Also: Gene expression, Self-reporting questionnairesBonding quality | Diagnostic test | Fullterm infants, Moderate to late preterm infants, Preterm infants with skin to skin contact, Preterm infants with visual contact |
Primary outcome
Bonding quality
Time frame: 6 to 8 years of age
Quality of mother infant bonding is assessed with the German version of the Attachment Story Completion Task (Bretherton and Ridgeway 1990)
Gene expression
Time frame: 6 to 8 years of age
Quantification of gene expression of six key molecules involved in stress response and neurobehavioural development
5 secondary outcomes
Maternal depression
Time frame: 6 to 8 years of age
Maternal perceived social support
Time frame: 6 to 8 years of age
Maternal parenting stress
Time frame: 6 to 8 years of age
Infant health and development
Time frame: 6 to 8 years of age
Infant behavior
Time frame: 6 to 8 years of age
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2020.
- Derived from this study: PubMed 39588126Trautmann-Villalba P, Heine E, Kribs A, Mehler K. Does early skin-to-skin contact have a long-term effect on the emotional and behavioral development of very preterm infants? Front Psychol. 2024 Nov 11;15:1484419. doi: 10.3389/fpsyg.2024.1484419. eCollection 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Premature Infant
Not yet recruiting
Effects of a Multisensory Intervention Program on the Term Behavior of the Very Premature Baby
Very Premature Baby
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Not yet recruiting
The Hemodynamic Impact of High-frequency Oscillatory Ventilation and Periodic Sighs in Preterm Infants
Preterm, Respiratory Distress Syndrome in Premature Infant
Not yet recruiting
Strap To Reduce Apnea in Preterm Infants: A Randomized Crossover Trial
Apnea of Prematurity, Intermittent Hypoxemia
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.
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 Premature Infant, 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 20 Nov 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katrin Mehler, MD (00492214785998, Katrin.Mehler@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bonding quality (time frame: 6 to 8 years of age). The study lists 2 primary outcomes in all. 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 NCT03366285, which also lists 1 linked publication.
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 20 Nov 2020.