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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-04

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Preterm Birth Mother-Infant Interaction Infant Development

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Study Groups

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Standard care

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

skin-to-skin contact

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.

Group Type EXPERIMENTAL

skin-to-skin contact

Intervention Type PROCEDURE

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

Interventions

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skin-to-skin contact

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No