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

University of Cologne

Status: Enrolling

Conditions: Mother-Infant Interaction; Infant Development; Preterm Birth

Treatments: Procedure: skin-to-skin contact

Study type: Interventional

Funder types: Other

Identifiers

NCT05975203

22-1419

Details and patient eligibility

About

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.

Full description

The planned study investigates prospectively the effect of early intervention (skin-to-skin contact in the delivery room) in moderate and late preterm infants on neonatal programming by determining gene expression in the stress signaling pathway. The working hypothesis of our project is that the intervention will affect gene expression in a way that subsequently leads to better long-term psycho-social and neurological development of these preterm infants. The study aims to improve the understanding of the correlation of behavioral and epigenetic parameters and prove the underlying hypothesis of a novel mechanistic link between immediate skin-to-skin contact in the delivery room and life-long stress tolerance.

Enrollment: 60 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Standard care

No Intervention group

Description:

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 group

Description:

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.

Treatment:

Procedure: skin-to-skin contact