Skin-to-skin contact for preterm infants at birth
Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
NA · University of Cologne · NCT05975203
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Sex | All |
| Sponsor | University of Cologne (other) |
| Locations | 1 site (Cologne, Northrhine-westfalia) |
| Trial ID | NCT05975203 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are preterm infants born between 32 and 36 weeks of gestation via vaginal delivery.
Not a fit: Patients with malformations, those requiring resuscitation, or mothers with severe health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the developmental outcomes and stress tolerance of preterm infants.
How similar studies have performed: Previous studies have shown positive outcomes with skin-to-skin contact in preterm infants, suggesting potential success for this approach.
Eligibility criteria
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 this trial is running
Cologne, Northrhine-westfalia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Preterm Birth, Mother-Infant Interaction, Infant Development, preterm behavioral epigenetics, skin-to-skin contact