Skin-to-skin contact for preterm infants at birth
Official title: Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
Run by University of Cologne · NCT05975203 · Data updated 2026-11-12
This study is testing whether immediate skin-to-skin contact after birth can help moderate and late preterm infants develop better and cope with stress.
Quick facts
| Study type | Interventional |
|---|---|
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | University of Cologne Academic / other |
| Locations | 1 site (Cologne, Northrhine-westfalia) |
| Status | Recruiting |
| Started | August 4, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2028 |
| Registry record updated | February 20, 2026 |
| Trial ID | NCT05975203 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are preterm infants born between 32 and 36 weeks of gestation via vaginal delivery.
✕Probably not a fit
Patients with malformations, those requiring resuscitation, or mothers with severe health issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial investigates the effects of immediate skin-to-skin contact on moderate and late preterm infants born vaginally. Participants will either be separated from their mothers after birth or receive skin-to-skin contact, allowing researchers to compare outcomes related to gene expression in stress signaling pathways and overall infant development. The study aims to establish a link between early skin-to-skin contact and improved long-term psychosocial and neurological outcomes for these infants.
Why it matters
Potential benefit: If successful, this approach could enhance the developmental outcomes and stress tolerance of preterm infants.
How similar studies have gone: Previous studies have shown positive outcomes with skin-to-skin contact in preterm infants, suggesting potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * preterm birth between gestational age of 32 0/7 and 36 6/7 weeks * vaginal delivery * singleton * informed consent before birth Exclusion Criteria: * malformations or syndromes of the infant * resuscitation of the infant * maternal psychological or severe physical illness * lack of German language skills
Where it's running
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University hospital of Cologne, Department of Neonatology
Cologne, Northrhine-westfalia, Germany Recruiting
Study contacts
- Principal investigator: Katrin Mehler, PD Dr. — University of Cologne
- Study coordinator: Katrin Mehler, PD Dr.
- Email: katrin.mehler@uk-koeln.de
- Phone: 004922147885663
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.