Immediate Skin-To-Skin Care For Preterm Infants After Birth (eSCC)

May 14, 2025 updated by: Medical University of Graz
The standard procedure in our centre for preterm neonates is to enable skin-to-skin (SSC) contact within 24 hours after birth. As early SSC immediately after birth might provide numerous positive effects for mothers and their preterm neonates, the objective of this study is to evaluate the feasibility, the safety and the effect of skin-to-skin contact immediately after birth in preterm neonates born with gestational age between 26+0 and 32+0 weeks.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
    • Styria
      • Graz, Styria, Austria, 8036
        • Recruiting
        • Medical University of Graz

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Gestational age between 26+0 and 32+0 weeks
  • Written parental informed consent

Exclusion Criteria:

  • No intention of full life support
  • Severe congenital malformation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early skin-to-skin care
Intervention group
Procedure: skin to skin care
skin to skin care of preterm infants with their parents immediately after birth
Active Comparator: Standard care group
Control group
Procedure: Standard Care (in control arm)
skin to skin care within 24 hours after birth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
vital parameter: Heart rate
Time Frame: during the first 2 hours after birth
during the first 2 hours after birth
vital parameter: Oxygen saturation
Time Frame: during the first 2 hours after birth
in percent
during the first 2 hours after birth
vital parameter: Temperature
Time Frame: during the first 2 hours after birth
during the first 2 hours after birth
vital parameter: blood pressure
Time Frame: during the first 2 hours after birth
systolic, diastolic and mean blood pressure
during the first 2 hours after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood sugar
Time Frame: 1 hour after birth
capillary blood sugar measured 1 hour after birth
1 hour after birth
FiO2 (Fraction of inspired oxygen)
Time Frame: during first 2 hours after birth
Need of oxygen
during first 2 hours after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Graz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 3, 2025

Primary Completion (Estimated)

February 3, 2027

Study Completion (Estimated)

February 3, 2027

Study Registration Dates

First Submitted

January 20, 2025

First Submitted That Met QC Criteria

January 20, 2025

First Posted (Actual)

January 27, 2025

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1309/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

It is single center study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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