Actively Recruiting

Phase Not Applicable
All Genders
ID05975203

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

Led by University of Cologne · Updated on 2026-02-20

60

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm birth between gestational age of 32 0/7 and 36 6/7 weeks
  • Vaginal delivery
  • Singleton pregnancy
  • Informed consent given before birth
Not Eligible

You will not qualify if you...

  • Infant has malformations or syndromes
  • Infant required resuscitation at birth
  • Mother has psychological or severe physical illness
  • Lack of German language skills

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

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)

Follow-up

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

Trial Site Locations

Total: 1 location

1

University hospital of Cologne, Department of Neonatology

Cologne, Northrhine-westfalia, Germany, 50931

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Research Team

K

Katrin Mehler, PD Dr.

A

Angela Kribs, PD Dr.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Delivery room skin-to-skin contact in preterm infants affects long-term expression of stress response genes.

Eva Hucklenbruch-Rother, Christina Vohlen, Nava Mehdiani...

https://pubmed.ncbi.nlm.nih.gov/33027708