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Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants

Study acronym: COSY
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 31, 2025 to Dec 31, 2026
    • Study completion date: Dec 31, 2026 to Dec 31, 2028
    v4
  2. Eligibility criteria shortened, about 2 wordsv3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05975203
Lead Sponsor University of Cologne
Conditions
(from sponsor)		 Preterm Birth, Mother-Infant Interaction, Infant Development
Related terms Premature Birth
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov