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

NCT05975203 | Recruiting

• 1 other identifier: 22-1419
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mother-Infant Interaction; Infant Development; Preterm Birth

Keywords

preterm behavioral epigenetics; skin-to-skin contact

Outcome Measures

Primary Outcomes (3)

• gene expression in candidate genes of the stress signalling pathway

  DNA will be extracted from peripheral white blood cells and mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.

  36 to 72 hours after birth

• gene expression in candidate genes of the stress signalling pathway

  DNA and RNA will be extracted from mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor. Furthermore a whole-genome methylation will be analysed.

  corrected 6 months of age

• gene expression in candidate genes of the stress signalling pathway

  DNA will be extracted from mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.

  corrected 24 months of age

Secondary Outcomes (10)

• mother-child-interaction

  corrected 6 months of age

• General Movements

  corrected 3 months of age

• maternal depression

  at inpatient discharge (assessed from 3 to 60 days of life), corrected 6 and 24 months of age

• social support

  at inpatient discharge (assessed from 3 to 60 days of life), corrected 24 months of age

• socio-economic status

  at inpatient discharge (assessed from 3 to 60 days of life)

Study Arms (2)

Standard care

NO INTERVENTION

After delivery the infant will be separated from the mother and placed on a primary care unit in another room to monitor the cardiopulmonary adaption for at least 20 minutes.

skin-to-skin contact

EXPERIMENTAL

After delivery the infant will be put skin-to-skin on the mother's breast in comfort position for 60 minutes. The cardiopulmonary adaption will be monitored and supervised by the attending neonatologist and nurse.

Procedure: skin-to-skin contact

Interventions

skin-to-skin contact PROCEDURE

Immediately after delivery the infant will receive skin-to-skin contact with the mother.

skin-to-skin contact

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• preterm birth between gestational age of 32 0/7 and 36 6/7 weeks
• vaginal delivery
• singleton
• informed consent before birth

You may not qualify if:

• malformations or syndromes of the infant
• resuscitation of the infant
• maternal psychological or severe physical illness
• lack of German language skills

Sponsors & Collaborators

• University of Cologne: lead

Study Sites (1)

University hospital of Cologne, Department of Neonatology

Cologne, Northrhine-westfalia, 50931, Germany

RECRUITING

Related Publications (2)

• Mehler K, Hucklenbruch-Rother E, Trautmann-Villalba P, Becker I, Roth B, Kribs A. Delivery room skin-to-skin contact for preterm infants-A randomized clinical trial. Acta Paediatr. 2020 Mar;109(3):518-526. doi: 10.1111/apa.14975. Epub 2019 Sep 16.

  PMID: 31423649 BACKGROUND

• Hucklenbruch-Rother E, Vohlen C, Mehdiani N, Keller T, Roth B, Kribs A, Mehler K. Delivery room skin-to-skin contact in preterm infants affects long-term expression of stress response genes. Psychoneuroendocrinology. 2020 Dec;122:104883. doi: 10.1016/j.psyneuen.2020.104883. Epub 2020 Sep 24.

  PMID: 33027708 BACKGROUND

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Katrin Mehler, PD Dr.

  University of Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Katrin Mehler, PD Dr.

CONTACT

004922147885663; katrin.mehler@uk-koeln.de

Angela Kribs, PD Dr.

CONTACT

004922147885663; angela.kribs@uk-koeln.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention blinding of participant and care provider is not possible. The investigators are part of the care providing team.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 13, 2023
• First Posted: August 3, 2023
• Study Start: August 4, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: February 20, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)