Immediate Skin-To-Skin Care For Preterm Infants After Birth
eSCC
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 20, 2025
CompletedFirst Posted
Study publicly available on registry
January 27, 2025
CompletedStudy Start
First participant enrolled
February 3, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 3, 2027
May 18, 2025
March 1, 2025
2 years
January 20, 2025
May 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
vital parameter: Heart rate
during the first 2 hours after birth
vital parameter: Oxygen saturation
in percent
during the first 2 hours after birth
vital parameter: blood pressure
systolic, diastolic and mean blood pressure
during the first 2 hours after birth
vital parameter: Temperature
during the first 2 hours after birth
Secondary Outcomes (2)
blood sugar
1 hour after birth
FiO2 (Fraction of inspired oxygen)
during first 2 hours after birth
Study Arms (2)
Early skin-to-skin care
EXPERIMENTALIntervention group
Standard care group
ACTIVE COMPARATORControl group
Interventions
skin to skin care of preterm infants with their parents immediately after birth
skin to skin care within 24 hours after birth
Eligibility Criteria
You may qualify if:
- Gestational age between 26+0 and 32+0 weeks
- Written parental informed consent
You may not qualify if:
- No intention of full life support
- Severe congenital malformation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical University of Graz
Graz, Styria, 8036, Austria
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2025
First Posted
January 27, 2025
Study Start
February 3, 2025
Primary Completion (Estimated)
February 3, 2027
Study Completion (Estimated)
February 3, 2027
Last Updated
May 18, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share
It is single center study