Effect of Skin to Skin Care in Preterm NeonateseSCCNCT06794164
Immediate Skin-To-Skin Care For Preterm Infants After Birth
A study testing skin to skin care in people with Effect of Skin to Skin Care in Preterm Neonates and Skin to Skin Care, run by Medical University of Graz at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 30 minutes
- Conditions the study is for
- Effect of Skin to Skin Care in Preterm Neonates, Skin to Skin Care
- What is being tested?
- skin to skin care
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 3 Feb 2025to 3 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 30 minutes
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age between 26+0 and 32+0 weeks
- Written parental informed consent
Who cannot join
- No intention of full life support
- Severe congenital malformation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz, Styria, 8036
About this study
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.
- Being tested
- skin to skin care, Standard Care (in control arm)
- Keywords
- skin to skin care, preterm neonates
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin to skin careProcedure or surgery
skin to skin care of preterm infants with their parents immediately after birth
Standard Care (in control arm)Procedure or surgery
skin to skin care within 24 hours after birth
| Study group | Role | What they receive |
|---|---|---|
| Early skin-to-skin care | Experimental | Intervention group Receives: Procedure: skin to skin care |
| Standard care group | Active comparator | Control group Receives: Procedure: Standard Care (in control arm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
vital parameter: Heart rate
Measured: during the first 2 hours after birth
vital parameter: Oxygen saturation
in percent
Measured: during the first 2 hours after birth
vital parameter: blood pressure
systolic, diastolic and mean blood pressure
Measured: during the first 2 hours after birth
vital parameter: Temperature
Measured: during the first 2 hours after birth
Secondary outcomes (2)
blood sugar
capillary blood sugar measured 1 hour after birth
Measured: 1 hour after birth
FiO2 (Fraction of inspired oxygen)
Need of oxygen
Measured: during first 2 hours after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start3 Feb 2025
- Primary completion3 Feb 2027 (estimated)
- Study completion3 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effect of Skin to Skin Care in Preterm NeonatesStudies of the same condition, open and under way.
- More trials run by Medical University of GrazThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06794164
- Sponsor's protocol ID
- 1309/2024
- Acronym
- eSCC
- Status last verified
- Oct 2026
- First submitted
- 20 Jan 2025
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: It is single center study
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Skin-To-Skin Care For Preterm Infants After Birth
- ClinicalTrials.gov ID
- NCT06794164
- Acronym / sponsor ID
- eSCC / 1309/2024
- Keywords
- skin to skin care, preterm neonates
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 3 Feb 2027 (estimated)
- Study completion
- 3 Feb 2027 (estimated)
- First posted
- 27 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early skin-to-skin care | Experimental | Procedure: skin to skin careIntervention group |
| Standard care group | Active comparator | Procedure: Standard Care (in control arm)Control group |
Who may qualify
- Ages
- 0 to 30 minutes
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Gestational age between 26+0 and 32+0 weeks
- Written parental informed consent
Key exclusion criteria (2 listed)
- No intention of full life support
- Severe congenital malformation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| skin to skin careskin to skin care of preterm infants with their parents immediately after birth | Procedure or surgery | Early skin-to-skin care |
| Standard Care (in control arm)skin to skin care within 24 hours after birth | Procedure or surgery | Standard care group |
Primary outcome
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
in percent
vital parameter: blood pressure
Time frame: during the first 2 hours after birth
systolic, diastolic and mean blood pressure
vital parameter: Temperature
Time frame: during the first 2 hours after birth
2 secondary outcomes
blood sugar
Time frame: 1 hour after birth
FiO2 (Fraction of inspired oxygen)
Time frame: during first 2 hours after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. It is single center study
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing skin to skin care in people with Effect of Skin to Skin Care in Preterm Neonates and Skin to Skin Care, run by Medical University of Graz at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nariae Baik-Schneditz, MD, PhD (+4331638582677, nariae.baik@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
vital parameter: Heart rate (time frame: during the first 2 hours after birth). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.