NCT07109076 (HRV-SCENE) is a NA clinical trial of skin-to-skin contact in Neonatal Adaptation, sponsored by University Medical Centre Ljubljana.

Who is sponsoring NCT07109076?

NCT07109076 is sponsored by University Medical Centre Ljubljana.

What drugs are being tested in NCT07109076?

Interventions in NCT07109076: skin-to-skin contact, routine care.

What condition does NCT07109076 study?

NCT07109076 studies Neonatal Adaptation.

Is NCT07109076 still recruiting?

NCT07109076 is currently recruiting now. Last updated 27 March 2026.

Last reviewed 2026-03-27 · How we verify

NCT07109076: HRV-SCENE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Immediate Skin-to-Skin Contact on Neonatal Heart Rate Variability After Cesarean Secton

Recruiting now NA Last updated 27 March 2026

What this trial tests

NA trial testing skin-to-skin contact in Neonatal Adaptation in 80 participants. Currently enrolling.

Timeline

1 March 2026

Primary endpoint
1 December 2026

2 December 2026

Quick facts

Lead sponsor	University Medical Centre Ljubljana
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	80
Start date	1 March 2026
Primary completion	1 December 2026
Estimated completion	2 December 2026
Sites	1 location across Slovenia

Drugs / interventions tested

skin-to-skin contact
routine care

Conditions studied

Neonatal Adaptation — all drugs for Neonatal Adaptation →

Sponsor

University Medical Centre Ljubljana

Who can join

0 and older, any sex, with Neonatal Adaptation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

At birth, both the newborn and the mother experience adaptive stress, which can be measured using objective physiological methods. One of the possible methods is monitoring heart rate variability, which is an indirect indicator of the balance between the sympathetic and parasympathetic branches of the autonomic nervous system. The proposed study will monitor the effect of early skin-to-skin contact on heart rate variability in newborns delivered by cesarean section and their mothers. The researchers hypothesize that newborns and mothers who are provided with immediate direct skin-to-skin contact, compared to the control group receiving standard care, will exhibit higher heart beat-to-beat interval variability in the first hours after birth. This is expected to result from reduced stress and activation of the parasympathetic nervous system. The study will include 80 newborn-mother pairs with a gestational age of 39 weeks or more, delivered via planned cesarean section. Participants will be randomly assigned to a study group (skin-to-skin contact lasting at least 15 minutes after cesarean birth) and a control group (standard care), with 40 newborns in each group. Maternal and neonatal ECG will be monitored for 15 minutes following cesarean birth in both groups. In addition, neonatal ECG will be monitored at 6, 12 and 24 hours postpartum. Time-domain analyses of hearth rate variability will be performed.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of skin-to-skin contact

Trials testing the same drug.

NCT05975203 — Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants · NA · recruiting
NCT04380051 — Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Prem · NA · recruiting
NCT05802147 — Analyse Of Early Skın To Skın Contact's Impact Upon Maternal-Infant Bondıng And Perceptıon Of Traumatıc Bırth · NA · completed

Other recruiting trials for Neonatal Adaptation

Currently open trials in the same condition.

NCT07453264 — Effect of Thermoregulation Bundle Applied at Birth on Neonatal Physiological Parameters and Breastfeeding · NA · recruiting

Other University Medical Centre Ljubljana trials

Trials by the same sponsor.

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NCT07446244 — Catheter Ablation of Advanced Forms of Atrial Fibrillation · NA · enrolling by invitation
NCT07354880 — Effect of Tirzepatide on Cardiovascular and Metabolic Parameters in Obese Adult Patients With Congenital Heart Disease · Phase 4 · not yet recruiting
NCT07496736 — Post-exposure Influenza Prophylaxis in a Hospital Setting · Phase 3 · active not recruiting
NCT07292506 — The Impact of Acupuncture on Biomarkers of Brain Injury and Inflammatory Response in Migraine · NA · active not recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT07109076 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University Medical Centre Ljubljana
Last refreshed: 27 March 2026

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07109076.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing