Delivery room skin-to-skin contact for preterm infants-A randomized clinical trial.
Katrin Mehler, Eva Hucklenbruch-Rother, Patricia Trautmann-Villalba...
https://pubmed.ncbi.nlm.nih.gov/31423649Actively Recruiting
Led by University of Cologne · Updated on 2026-02-20
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
Researchers are investigating the effects of early skin-to-skin contact in moderate and late preterm infants, specifically those born between 32 0/7 and 36 6/7 weeks gestation via vaginal delivery. This study aims to understand how immediate skin-to-skin contact influences gene expression in the stress signaling pathway and whether it improves short- and long-term developmental outcomes compared to immediate separation after birth. The research seeks to explore a possible link between early skin-to-skin contact and lifelong stress tolerance and neurodevelopment. Participants are randomly assigned to one of two groups after birth. One group will have the infant separated from the mother and placed in another room for cardiopulmonary monitoring for at least 20 minutes. The other group will have immediate skin-to-skin contact with the mother for 60 minutes while the infant's cardiopulmonary adaptation is closely monitored by medical staff. This comparison will help assess the effects of the intervention. Throughout the study, researchers will evaluate gene expression related to the stress signaling pathway at 36 to 72 hours after birth, as well as at corrected ages of 6 and 24 months. Additional assessments include mother-child interaction, infant movements, maternal depression, social support, breastfeeding, parental bonding and stress, and hypothalamic-pituitary-adrenal axis reactivity. These measurements will provide insight into the infants' developmental progress and the long-term impact of skin-to-skin contact. Participation involves monitoring during hospitalization and follow-up assessments up to two years of age.
CONDITIONS
Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - At birth and up to 60 minutes after delivery
Participants receive either skin-to-skin contact immediately after delivery or standard care where the infant is separated from the mother and monitored.
1 delivery room visit (in-person)
Duration - Up to 24 months after birth
Participants are monitored with assessments of gene expression and developmental outcomes up to 24 months of age.
Visits at 3 months, 6 months, and 24 months corrected age for assessments
Total: 1 location
1
University hospital of Cologne, Department of Neonatology
Cologne, Northrhine-westfalia, Germany, 50931
Actively Recruiting
K
Katrin Mehler, PD Dr.
A
Angela Kribs, PD Dr.
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Katrin Mehler, Eva Hucklenbruch-Rother, Patricia Trautmann-Villalba...
https://pubmed.ncbi.nlm.nih.gov/31423649Eva Hucklenbruch-Rother, Christina Vohlen, Nava Mehdiani...
https://pubmed.ncbi.nlm.nih.gov/33027708