Preterm BirthCOSYNCT05975203
Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
A study testing skin-to-skin contact in people with Preterm Birth and Mother-Infant Interaction, run by University of Cologne at 1 site in Germany.
Trial summary
The goal of this randomized controlled trial is to compare the effect of direct skin-to-skin contact in moderate and late preterm infants. The main questions it aims to answer are: does skin-to-skin contact in moderate and late preterm infants influence gene expression in the stress signaling pathway? does… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm Birth, Mother-Infant Interaction, Infant Development
- What is being tested?
- skin-to-skin contact
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 4 Aug 2023to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- preterm birth between gestational age of 32 0/7 and 36 6/7 weeks
- vaginal delivery
- singleton
- informed consent before birth
Who cannot join
- malformations or syndromes of the infant
- resuscitation of the infant
- maternal psychological or severe physical illness
- lack of German language skills
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
University hospital of Cologne, Department of Neonatology
Cologne, Northrhine-westfalia, 50931
Katrin Mehler, MD, 004922147885663, katrin.mehler@uk-koeln.de
Angela Kribs, MD, 004922147885663, angela.kribs@uk-koeln.de
About this study
The goal of this randomized controlled trial is to compare the effect of direct skin-to-skin contact in moderate and late preterm infants. The main questions it aims to answer are:
- does skin-to-skin contact in moderate and late preterm infants influence gene expression in the stress signaling pathway?
- does skin-to-skin contact in moderate and late preterm infants improve the short- and long-term outcome?
Participants will either get immediate separation after vaginal birth or receive immediate skin-to-skin contact. Researchers will compare these two groups to answer the proposed questions.
Read the detailed description
The planned study investigates prospectively the effect of early intervention (skin-to-skin contact in the delivery room) in moderate and late preterm infants on neonatal programming by determining gene expression in the stress signaling pathway. The working hypothesis of our project is that the intervention will affect gene expression in a way that subsequently leads to better long-term psycho-social and neurological development of these preterm infants. The study aims to improve the understanding of the correlation of behavioral and epigenetic parameters and prove the underlying hypothesis of a novel mechanistic link between immediate skin-to-skin contact in the delivery room and life-long stress tolerance.
- Conditions
- Preterm Birth, Mother-Infant Interaction, Infant Development
- Being tested
- skin-to-skin contact
- Keywords
- preterm behavioral epigenetics, skin-to-skin contact
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin-to-skin contactProcedure or surgery
Immediately after delivery the infant will receive skin-to-skin contact with the mother.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | After delivery the infant will be separated from the mother and placed on a primary care unit in another room to monitor the cardiopulmonary adaption for at least 20 minutes. |
| skin-to-skin contact | Experimental | After delivery the infant will be put skin-to-skin on the mother's breast in comfort position for 60 minutes. The cardiopulmonary adaption will be monitored and supervised by the attending neonatologist and nurse. Receives: Procedure: skin-to-skin contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
gene expression in candidate genes of the stress signalling pathway
DNA will be extracted from peripheral white blood cells and mucosal epithelial cells. The expression 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 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.
Measured: 36 to 72 hours after birth
gene expression in candidate genes of the stress signalling pathway
DNA and RNA will be extracted from mucosal epithelial cells. The expression 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 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor. Furthermore a whole-genome methylation will be analysed.
Measured: corrected 6 months of age
gene expression in candidate genes of the stress signalling pathway
DNA will be extracted from mucosal epithelial cells. The expression 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 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.
Measured: corrected 24 months of age
Secondary outcomes (10)
mother-child-interaction
Mother-child-interaction is investigated 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.
Measured: corrected 6 months of age
General Movements
The early infant development will be analyzed by general movements assessment by Prechtl. It is a validated diagnostic tool for the functional assessment of the young nervous system.
Measured: corrected 3 months of age
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: at inpatient discharge (assessed from 3 to 60 days of life), corrected 6 and 24 months of age
social support
Social support is assessed with the short version of the German questionnaire for social support (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: at inpatient discharge (assessed from 3 to 60 days of life), corrected 24 months of age
socio-economic status
There will be a question to the household income per month and the parents' highest school-leaving certificate as well as the housing situation.
Measured: at inpatient discharge (assessed from 3 to 60 days of life)
breastfeeding
There will be a question about breastfeeding.
Measured: at inpatient discharge (assessed from 3 to 60 days of life) and corrected six months of age
impact of event scale
Symptoms for post-traumatic stress is assessed with the impact of event scale - revised (IES-R). It is a self-report questionnaire and consists of 22 questions. For each question the response choice are assigned point values (how often a symptom occurred during the last week). The sub-scale values are summed by the corresponding sub-scale items. The three sub-scales are: intrusion, avoidance and hyperarousal. The overall result is calculated by a formula. The score ranges from -4,36 to 2,99. A result above 0 is interpreted to indicate a risk of post-traumatic stress disorder.
Measured: corrected 6 months of age
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 sub-scales and the point values of each sub-scale are summed to a total measure score. The four sub-scales 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 sub-scale.
Measured: corrected 6 and 24 months of age
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: corrected 6 and 24 months of age
reactivity of hypothalamic-pituitary-adrenal-axis
Salivary cortisol is measured before and 20 minutes after heel lance, respectively after a stressful testing. The saliva is collected by a small cotton roll, which is placed in the infants' mouth. The cortisol is assayed in duplicate using an immunoassay, which is a validated test.
Measured: 36 to 72 hours after birth and corrected 24 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2023
- Study start4 Aug 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
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 Preterm BirthStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 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
- Investigators
- Katrin Mehler, PD Dr., Principal investigator, University of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05975203
- Sponsor's protocol ID
- 22-1419
- Acronym
- COSY
- Status last verified
- Oct 2025
- First submitted
- 13 Jul 2023
- Last updated
- 20 Feb 2026
- 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, 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.
PubMed 31423649Hucklenbruch-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.
PubMed 33027708
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
- ClinicalTrials.gov ID
- NCT05975203
- Acronym / sponsor ID
- COSY / 22-1419
- Conditions
- Preterm Birth, Mother-Infant Interaction, Infant Development
- Keywords
- preterm behavioral epigenetics, skin-to-skin contact
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- 4 Aug 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 3 Aug 2023 (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 goal of this randomized controlled trial is to compare the effect of direct skin-to-skin contact in moderate and late preterm infants. The main questions it aims to answer are:
- does skin-to-skin contact in moderate and late preterm infants influence gene expression in the stress signaling pathway?
- does skin-to-skin contact in moderate and late preterm infants improve the short- and long-term outcome?
Participants will either get immediate separation after vaginal birth or receive immediate skin-to-skin contact. Researchers will compare these two groups to answer the proposed questions.
Detailed description
The planned study investigates prospectively the effect of early intervention (skin-to-skin contact in the delivery room) in moderate and late preterm infants on neonatal programming by determining gene expression in the stress signaling pathway. The working hypothesis of our project is that the intervention will affect gene expression in a way that subsequently leads to better long-term psycho-social and neurological development of these preterm infants. The study aims to improve the understanding of the correlation of behavioral and epigenetic parameters and prove the underlying hypothesis of a novel mechanistic link between immediate skin-to-skin contact in the delivery room and life-long stress tolerance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –After delivery the infant will be separated from the mother and placed on a primary care unit in another room to monitor the cardiopulmonary adaption for at least 20 minutes. |
| skin-to-skin contact | Experimental | Procedure: skin-to-skin contactAfter delivery the infant will be put skin-to-skin on the mother's breast in comfort position for 60 minutes. The cardiopulmonary adaption will be monitored and supervised by the attending neonatologist and nurse. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- preterm birth between gestational age of 32 0/7 and 36 6/7 weeks
- vaginal delivery
- singleton
- informed consent before birth
Key exclusion criteria (4 listed)
- malformations or syndromes of the infant
- resuscitation of the infant
- maternal psychological or severe physical illness
- lack of German language skills
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 |
|---|---|---|
| skin-to-skin contactImmediately after delivery the infant will receive skin-to-skin contact with the mother. | Procedure or surgery | skin-to-skin contact |
Primary outcome
gene expression in candidate genes of the stress signalling pathway
Time frame: 36 to 72 hours after birth
DNA will be extracted from peripheral white blood cells and mucosal epithelial cells. The expression 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 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.
gene expression in candidate genes of the stress signalling pathway
Time frame: corrected 6 months of age
DNA and RNA will be extracted from mucosal epithelial cells. The expression 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 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor. Furthermore a whole-genome methylation will be analysed.
gene expression in candidate genes of the stress signalling pathway
Time frame: corrected 24 months of age
DNA will be extracted from mucosal epithelial cells. The expression 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 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.
10 secondary outcomes
mother-child-interaction
Time frame: corrected 6 months of age
General Movements
Time frame: corrected 3 months of age
maternal depression
Time frame: at inpatient discharge (assessed from 3 to 60 days of life), corrected 6 and 24 months of age
social support
Time frame: at inpatient discharge (assessed from 3 to 60 days of life), corrected 24 months of age
socio-economic status
Time frame: at inpatient discharge (assessed from 3 to 60 days of life)
breastfeeding
Time frame: at inpatient discharge (assessed from 3 to 60 days of life) and corrected six months of age
impact of event scale
Time frame: corrected 6 months of age
Parental Bonding
Time frame: corrected 6 and 24 months of age
Parental Stress
Time frame: corrected 6 and 24 months of age
reactivity of hypothalamic-pituitary-adrenal-axis
Time frame: 36 to 72 hours after birth and corrected 24 months of age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2026.
- Background: PubMed 31423649Mehler 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.
- Background: PubMed 33027708Hucklenbruch-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.
- 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.
Katrin Mehler, PD Dr. 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?
A study testing skin-to-skin contact in people with Preterm Birth and Mother-Infant 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 4 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: looking for participants now, as of the sponsor's last update on 20 Feb 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katrin Mehler, PD Dr. (004922147885663, 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?
gene expression in candidate genes of the stress signalling pathway (time frame: 36 to 72 hours after birth). The study lists 3 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 NCT05975203, 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 20 Feb 2026.