Clinical trial Recruiting at 1 site Interventional

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.

More Preterm Birth trials

Quick facts

Study typeInterventional
SexAll
Enrollment60 (estimated)
SponsorUniversity of Cologne
Academic / other
Locations1 site (Cologne, Northrhine-westfalia)
StatusRecruiting
StartedAugust 4, 2023
Main results expectedDecember 31, 2026
Study endsDecember 31, 2028
Registry record updatedFebruary 20, 2026
Trial IDNCT05975203 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

  • University hospital of Cologne, Department of Neonatology
    Cologne, Northrhine-westfalia, Germany
    Recruiting

Study contacts

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.