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Recruiting NCT06794164

Immediate Skin-To-Skin Care For Preterm Infants After Birth

No phase Interventional Effect of Skin to Skin Care in Preterm Neonates Skin to Skin Care

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: skin to skin care, Standard Care (in control arm).
Who it may be relevant to
Registry conditions: Effect of Skin to Skin Care in Preterm Neonates, Skin to Skin Care. Basic parameters: 0 Minutes — 30 Minutes · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure skin to skin care
    skin to skin care of preterm infants with their parents immediately after birth
  • Procedure Standard Care (in control arm)
    skin to skin care within 24 hours after birth

Primary outcome measures

  • vital parameter: Heart rate [Time frame: during the first 2 hours after birth]
  • vital parameter: Oxygen saturation [Time frame: during the first 2 hours after birth]
  • vital parameter: blood pressure [Time frame: during the first 2 hours after birth]
  • vital parameter: Temperature [Time frame: during the first 2 hours after birth]
Secondary outcome measures (2)
  • blood sugar [Time frame: 1 hour after birth]
  • FiO2 (Fraction of inspired oxygen) [Time frame: during first 2 hours after birth]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Austria · 1 center
  • Medical University of Graz — Graz

Identifiers

NCT: NCT06794164 · 1309/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗