Very Low Birthweight InfantsdeisyNCT01959737
Delivery Room Skin-to-skin Study
A study testing skin-to.skin-contact in people with Very Low Birthweight Infants and Mother Child Interaction, run by University of Cologne at 1 site in Germany.
Trial summary
The first hours after birth are a sensitive period for promotion of optimal mother-child-interaction and secure attachment. Maternal sensitivity and responsivness are high in the first hours after birth due to high oxytocin levels. Read more about this study
- Who is it for?
- Ages 10 to 60 minutes
- Conditions the study is for
- Very Low Birthweight Infants, Mother Child Interaction, Preterm Infant
- 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
- 88 participants
- Where
- 1 siteGermany
- Study dates
- Oct 2013to Jan 2016
- Phase
- Interventional
- 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 10 to 60 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Birthweight <1500g, first child, informed consent
Who cannot join
- Multiples, malformation
Trial locations and contacts
1 site in 1 country.
Germany1 site
University hospital of Cologne, Department of Neonatology
Cologne
About this study
Official title: Influence of Early SSC of Mothers and Their VLBW Infants on Maternal Sensitivity and Responsiveness, Attachment Patterns and Reactivity of HPA Axis. Molecular Characterization of SSC Influence on Stress Signaling Pathways.
The first hours after birth are a sensitive period for promotion of optimal mother-child-interaction and secure attachment. Maternal sensitivity and responsivness are high in the first hours after birth due to high oxytocin levels. Developing optimal mother-child-interaction is more difficult for preterm mothers because mother and child are separated after birth and the preterm infant is not able to show strong signs to promote maternal sensitivity. We hypothesize that promoting skin-to-skin contact of VLBW infants and their mothers for 60 minutes within the first hours after birth improves mother-child-interaction at 5 to 6 months corrected age. We also hypothesize that reactivity of HPA axis and molecular patterns of stress signaling pathways differ in preterm infant with or without SSC after birth.
- Being tested
- skin-to.skin-contact
- Keywords
- reactivity of HPA axis
- 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 initial stabilization/ assessment of the VLBW infant, skin-to-skin contact of mother and infant is initiated and kept up for 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| visual contact | No intervention | After initial assessment/stabilization of the VLBW infant, visual contact of mother and infant is permitted for 5 minutes. |
| skin-to-skin contact | Experimental | After initial stabilization mother and preterm infant are cared for skin-to-skin for 60 minuter. SSC is supervised by the attending neonatologist. Receives: Procedure: skin-to.skin-contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal sensitivity and responsiveness
Maternal sensitivity and responsiveness are assessed with the "Mannheimer Method" for the analysis of mother child interaction. At the infants corrected age of 4 to 6 months a videotape of the mother changing the infants diapers and playing with the infant is used for analysis.
Measured: 4 to 6 moinths corrected age
Secondary outcomes (2)
Reactivity of HPA-axis
Salivary cortisol assessment before and 20 minutes after heel lance
Measured: 36 to 40 weeks corrected age
Molecular characterization of stress signaling pathways
Genomic expression of the Glucocorticoid receptor (NR3C1), Corticotropin releasing hormon (CRH), Corticotropin releasing hormon receptor 1 (CRHR1), serotonin receptor 1A and 2A, serotonin transporter (slc6a4), vasopressin
Measured: 36 to 40 weeks corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionJul 2015
- Study completionJan 2016
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 Very Low Birthweight InfantsStudies 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
- None (open label)
- Enrolment
- 88 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
- NCT01959737
- Sponsor's protocol ID
- 11-075
- Acronym
- deisy
- Status last verified
- Jun 2018
- First submitted
- 7 Oct 2013
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mehler K, Wendrich D, Kissgen R, Roth B, Oberthuer A, Pillekamp F, Kribs A. Mothers seeing their VLBW infants within 3 h after birth are more likely to establish a secure attachment behavior: evidence of a sensitive period with preterm infants? J Perinatol. 2011 Jun;31(6):404-10. doi: 10.1038/jp.2010.139. Epub 2010 Dec 9.
PubMed 21151007Trautmann-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 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Early SSC of Mothers and Their VLBW Infants on Maternal Sensitivity and Responsiveness, Attachment Patterns and Reactivity of HPA Axis. Molecular Characterization of SSC Influence on Stress Signaling Pathways.
- ClinicalTrials.gov ID
- NCT01959737
- Acronym / sponsor ID
- deisy / 11-075
- Keywords
- reactivity of HPA axis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Study start
- Oct 2013 (actual)
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 10 Oct 2013 (estimated)
- 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 first hours after birth are a sensitive period for promotion of optimal mother-child-interaction and secure attachment. Maternal sensitivity and responsivness are high in the first hours after birth due to high oxytocin levels. Developing optimal mother-child-interaction is more difficult for preterm mothers because mother and child are separated after birth and the preterm infant is not able to show strong signs to promote maternal sensitivity. We hypothesize that promoting skin-to-skin contact of VLBW infants and their mothers for 60 minutes within the first hours after birth improves mother-child-interaction at 5 to 6 months corrected age. We also hypothesize that reactivity of HPA axis and molecular patterns of stress signaling pathways differ in preterm infant with or without SSC after birth.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| visual contact | No intervention | –After initial assessment/stabilization of the VLBW infant, visual contact of mother and infant is permitted for 5 minutes. |
| skin-to-skin contact | Experimental | Procedure: skin-to.skin-contactAfter initial stabilization mother and preterm infant are cared for skin-to-skin for 60 minuter. SSC is supervised by the attending neonatologist. |
Who may qualify
- Ages
- 10 to 60 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Birthweight <1500g, first child, informed consent
Key exclusion criteria (1 listed)
- Multiples, malformation
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 initial stabilization/ assessment of the VLBW infant, skin-to-skin contact of mother and infant is initiated and kept up for 60 minutes. | Procedure or surgery | skin-to-skin contact |
Primary outcome
Maternal sensitivity and responsiveness
Time frame: 4 to 6 moinths corrected age
Maternal sensitivity and responsiveness are assessed with the "Mannheimer Method" for the analysis of mother child interaction. At the infants corrected age of 4 to 6 months a videotape of the mother changing the infants diapers and playing with the infant is used for analysis.
2 secondary outcomes
Reactivity of HPA-axis
Time frame: 36 to 40 weeks corrected age
Molecular characterization of stress signaling pathways
Time frame: 36 to 40 weeks corrected age
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 26 Jun 2018.
- Background: PubMed 21151007Mehler K, Wendrich D, Kissgen R, Roth B, Oberthuer A, Pillekamp F, Kribs A. Mothers seeing their VLBW infants within 3 h after birth are more likely to establish a secure attachment behavior: evidence of a sensitive period with preterm infants? J Perinatol. 2011 Jun;31(6):404-10. doi: 10.1038/jp.2010.139. Epub 2010 Dec 9.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Very Low Birthweight Infants and 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 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: finished, as of the sponsor's last update on 26 Jun 2018. 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?
Maternal sensitivity and responsiveness (time frame: 4 to 6 moinths corrected age). 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 NCT01959737, 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 26 Jun 2018.