Neonatal AdaptationHRV-SCENENCT07109076
Effect of Immediate Skin-to-Skin Contact on Neonatal Heart Rate Variability After Cesarean Secton
A study testing skin-to-skin contact and routine care in people with Neonatal Adaptation, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 years and older
- Conditions the study is for
- Neonatal Adaptation
- What is being tested?
- skin-to-skin contact and routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSlovenia
- Study dates
- 1 Mar 2026to 2 Dec 2026
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- planned cesarean section
- gestational age 39 weeks 0/7 or more
Who cannot join
- Pregnancy complications (e.g. hypertensive disorders in pregnancy, fetal growth restriction, etc.)
- neonatal resuscitation at birth
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Center Ljubljana
Ljubljana, Ljubljana, 1000
Miha Lucovnik, MD, PhD, +38615229530, miha.lucovnik@kclj.si
About this study
Official title: Effect of Immediate Skin-to-Skin Contact With the Mother on Heart Rate Variability in Newborns After Cesarean Secton
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.
Read the detailed description
At the time of birth, both the newborn and the mother undergo a complex and dynamic process of physiological and psychological adaptation, often referred to as perinatal adaptive stress. This adaptive stress response involves significant alterations in neuroendocrine and autonomic function, including activation of the hypothalamic-pituitary-adrenal (HPA) axis and fluctuations in autonomic nervous system (ANS) activity. These physiological responses can be objectively assessed using various biomarkers and physiological parameters. Among the most informative and non-invasive indicators of autonomic regulation is heart rate variability (HRV)-a measure of the variation in time intervals between consecutive heartbeats (RR intervals), which reflects the interplay between the sympathetic and parasympathetic branches of the ANS.
HRV has been widely used in neonatal and maternal research as a surrogate marker of stress, resilience, and autonomic function. High HRV is generally associated with enhanced parasympathetic (vagal) tone and a more flexible and adaptive physiological state, whereas low HRV is indicative of stress, reduced vagal activity, and sympathetic predominance. The immediate postpartum period, particularly following cesarean delivery, represents a critical window during which both maternal and neonatal physiological systems transition from intrauterine to extrauterine life, often in the absence of the hormonal and mechanical stimuli associated with vaginal delivery.
The proposed randomized controlled trial aims to investigate the effect of early skin-to-skin contact (SSC) between mother and newborn on HRV in both participants following planned cesarean section. Early SSC has been shown in previous studies to promote maternal-infant bonding, thermoregulation, breastfeeding initiation, and physiological stability; however, its impact on autonomic modulation as assessed by HRV-particularly in cesarean births-remains underexplored.
The central hypothesis of this study is that immediate and sustained skin-to-skin contact will result in significantly greater HRV in both neonates and mothers, as compared to a control group receiving standard post-cesarean care. This increase in HRV is expected to reflect reduced perinatal stress, enhanced vagal activation, and improved autonomic balance during the early postpartum period.
The study will enroll 80 mother-newborn dyads with a gestational age of ≥39 weeks undergoing elective cesarean section. Participants will be randomly assigned to either the intervention group, in which uninterrupted skin-to-skin contact will be initiated immediately and maintained for at least 15 minutes following birth, or the control group, which will receive routine postnatal care without early SSC. Each group will comprise 40 dyads.
Electrocardiographic (ECG) monitoring will be conducted in both mothers and newborns during the first 15 minutes following birth to capture real-time cardiac data. In addition, neonatal ECG will be monitored at 6, 12 and 24 hours postpartum. HRV will be analyzed using time-domain methods, in accordance with established international standards.
- Conditions
- Neonatal Adaptation
- Being tested
- skin-to-skin contact, routine care
- Keywords
- heart rate variability, cesarean section, cesarean birth, skin-to-skin contact
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
skin-to-skin contactOther
Uninterrupted skin-to-skin contact between the neonate and the mother will be initiated immediately and maintained for at least 15 minutes following cesarean birth.
routine careOther
Current routine neonatal care following cesarean section includes delayed umbilical cord clamping. Afterward, the newborn is dried by a midwife, dressed, briefly shown to the mother, and then handed over to the father.
| Study group | Role | What they receive |
|---|---|---|
| skin-to-skin contact group | Experimental | Uninterrupted skin-to-skin contact between the neonate and the mother will be initiated immediately and maintained for at least 15 minutes following cesarean birth. Receives: Other: skin-to-skin contact |
| control group | Active comparator | Neonates and mother in this arm will receive routine postnatal care without early skin-to-skin contact. Current routine neonatal care following cesarean section includes delayed umbilical cord clamping. Afterward, the newborn is dried by a midwife, dressed, briefly shown to the mother, and then handed over to the father. Receives: Other: routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal RMSSD 15 minutes after birth
RMSSD is a time-domain HRV measure. It is defined as the square root of the mean of the squares of successive differences between adjacent normal (NN) heartbeats (i.e., RR intervals) and expressed in milliseconds (ms).
Measured: 15 minutes following cesarean birth.
Neonatal SDNN 15 minutes after birth
SDNN is a time-domain HRV measure. It is defined as the standard deviation of all normal-to-normal (NN) RR intervals over the recorded period and expressed in milliseconds (ms).
Measured: 15 minutes following cesarean birth
Neonatal pNN50 15 minutes after birth
pNN50 is a time-domain HRV measure. It is defined as the percentage of successive NN (normal-to-normal) intervals that differ from each other by more than 50 milliseconds.
Measured: 15 minutes following cesarean birth
Secondary outcomes (12)
Maternal RMSSD 15 minutes after birth
RMSSD is a time-domain HRV measure. It is defined as the square root of the mean of the squares of successive differences between adjacent normal (NN) heartbeats (i.e., RR intervals) and expressed in milliseconds (ms).
Measured: 15 minutes following cesarean birth
Maternal SDNN 15 minutes after birth
SDNN is a time-domain HRV measure. It is defined as the standard deviation of all normal-to-normal (NN) RR intervals over the recorded period and expressed in milliseconds (ms).
Measured: 15 minutes following cesarean birth
Maternal pNN50 15 minutes after birth
pNN50 is a time-domain HRV measure. It is defined as the percentage of successive NN (normal-to-normal) intervals that differ from each other by more than 50 milliseconds.
Measured: 15 minutes following cesarean birth
Neonatal RMSSD 6 hours after birth
RMSSD is a time-domain HRV measure. It is defined as the square root of the mean of the squares of successive differences between adjacent normal (NN) heartbeats (i.e., RR intervals) and expressed in milliseconds (ms).
Measured: 6 hours after cesarean birth
Neonatal SDNN 6 hours after birth
SDNN is a time-domain HRV measure. It is defined as the standard deviation of all normal-to-normal (NN) RR intervals over the recorded period and expressed in milliseconds (ms).
Measured: 6 hours after cesarean birth
Neonatal pNN50 6 hours after birth
pNN50 is a time-domain HRV measure. It is defined as the percentage of successive NN (normal-to-normal) intervals that differ from each other by more than 50 milliseconds.
Measured: 6 hours after cesarean birth
Neonatal RMSSD 12 hours after birth
RMSSD is a time-domain HRV measure. It is defined as the square root of the mean of the squares of successive differences between adjacent normal (NN) heartbeats (i.e., RR intervals) and expressed in milliseconds (ms).
Measured: 12 hours after cesarean birth
Neonatal SDNN 12 hours after birth
SDNN is a time-domain HRV measure. It is defined as the standard deviation of all normal-to-normal (NN) RR intervals over the recorded period and expressed in milliseconds (ms).
Measured: 12 hours after cesarean birth
Neonatal pNN50 12 hours after birth
pNN50 is a time-domain HRV measure. It is defined as the percentage of successive NN (normal-to-normal) intervals that differ from each other by more than 50 milliseconds.
Measured: 12 hours after cesarean birth
Neonatal RMSSD 24 hours after birth
RMSSD is a time-domain HRV measure. It is defined as the square root of the mean of the squares of successive differences between adjacent normal (NN) heartbeats (i.e., RR intervals) and expressed in milliseconds (ms).
Measured: 24 hours after cesarean birth
Neonatal SDNN 24 hours after birth
SDNN is a time-domain HRV measure. It is defined as the standard deviation of all normal-to-normal (NN) RR intervals over the recorded period and expressed in milliseconds (ms).
Measured: 24 hours after cesarean birth
Neonatal pNN50 24 hours after birth
pNN50 is a time-domain HRV measure. It is defined as the percentage of successive NN (normal-to-normal) intervals that differ from each other by more than 50 milliseconds.
Measured: 24 hours after cesarean birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start1 Mar 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion2 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonatal AdaptationStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miha Lucovnik, University Medical Centre Ljubljana
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109076
- Sponsor's protocol ID
- 0120-227/2025-2711-4
- Acronym
- HRV-SCENE
- Status last verified
- Mar 2026
- First submitted
- 3 Jul 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD will be stored and shared upon request.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Immediate Skin-to-Skin Contact With the Mother on Heart Rate Variability in Newborns After Cesarean Secton
- ClinicalTrials.gov ID
- NCT07109076
- Acronym / sponsor ID
- HRV-SCENE / 0120-227/2025-2711-4
- Conditions
- Neonatal Adaptation
- Keywords
- heart rate variability, cesarean section, cesarean birth, skin-to-skin contact
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 7 Aug 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.
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.
Detailed description
At the time of birth, both the newborn and the mother undergo a complex and dynamic process of physiological and psychological adaptation, often referred to as perinatal adaptive stress. This adaptive stress response involves significant alterations in neuroendocrine and autonomic function, including activation of the hypothalamic-pituitary-adrenal (HPA) axis and fluctuations in autonomic nervous system (ANS) activity. These physiological responses can be objectively assessed using various biomarkers and physiological parameters. Among the most informative and non-invasive indicators of autonomic regulation is heart rate variability (HRV)-a measure of the variation in time intervals between consecutive heartbeats (RR intervals), which reflects the interplay between the sympathetic and parasympathetic branches of the ANS.
HRV has been widely used in neonatal and maternal research as a surrogate marker of stress, resilience, and autonomic function. High HRV is generally associated with enhanced parasympathetic (vagal) tone and a more flexible and adaptive physiological state, whereas low HRV is indicative of stress, reduced vagal activity, and sympathetic predominance. The immediate postpartum period, particularly following cesarean delivery, represents a critical window during which both maternal and neonatal physiological systems transition from intrauterine to extrauterine life, often in the absence of the hormonal and mechanical stimuli associated with vaginal delivery.
The proposed randomized controlled trial aims to investigate the effect of early skin-to-skin contact (SSC) between mother and newborn on HRV in both participants following planned cesarean section. Early SSC has been shown in previous studies to promote maternal-infant bonding, thermoregulation, breastfeeding initiation, and physiological stability; however, its impact on autonomic modulation as assessed by HRV-particularly in cesarean births-remains underexplored.
The central hypothesis of this study is that immediate and sustained skin-to-skin contact will result in significantly greater HRV in both neonates and mothers, as compared to a control group receiving standard post-cesarean care. This increase in HRV is expected to reflect reduced perinatal stress, enhanced vagal activation, and improved autonomic balance during the early postpartum period.
The study will enroll 80 mother-newborn dyads with a gestational age of ≥39 weeks undergoing elective cesarean section. Participants will be randomly assigned to either the intervention group, in which uninterrupted skin-to-skin contact will be initiated immediately and maintained for at least 15 minutes following birth, or the control group, which will receive routine postnatal care without early SSC. Each group will comprise 40 dyads.
Electrocardiographic (ECG) monitoring will be conducted in both mothers and newborns during the first 15 minutes following birth to capture real-time cardiac data. In addition, neonatal ECG will be monitored at 6, 12 and 24 hours postpartum. HRV will be analyzed using time-domain methods, in accordance with established international standards.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| skin-to-skin contact group | Experimental | Other: skin-to-skin contactUninterrupted skin-to-skin contact between the neonate and the mother will be initiated immediately and maintained for at least 15 minutes following cesarean birth. |
| control group | Active comparator | Other: routine careNeonates and mother in this arm will receive routine postnatal care without early skin-to-skin contact. Current routine neonatal care following cesarean section includes delayed umbilical cord clamping. Afterward, the newborn is dried by a midwife, dressed, briefly shown to the mother, and then handed over to the father. |
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- planned cesarean section
- gestational age 39 weeks 0/7 or more
Key exclusion criteria (2 listed)
- Pregnancy complications (e.g. hypertensive disorders in pregnancy, fetal growth restriction, etc.)
- neonatal resuscitation at birth
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 contactUninterrupted skin-to-skin contact between the neonate and the mother will be initiated immediately and maintained for at least 15 minutes following cesarean birth. | Other | skin-to-skin contact group |
| routine careCurrent routine neonatal care following cesarean section includes delayed umbilical cord clamping. Afterward, the newborn is dried by a midwife, dressed, briefly shown to the mother, and then handed over to the father. | Other | control group |
Primary outcome
Neonatal RMSSD 15 minutes after birth
Time frame: 15 minutes following cesarean birth.
RMSSD is a time-domain HRV measure. It is defined as the square root of the mean of the squares of successive differences between adjacent normal (NN) heartbeats (i.e., RR intervals) and expressed in milliseconds (ms).
Neonatal SDNN 15 minutes after birth
Time frame: 15 minutes following cesarean birth
SDNN is a time-domain HRV measure. It is defined as the standard deviation of all normal-to-normal (NN) RR intervals over the recorded period and expressed in milliseconds (ms).
Neonatal pNN50 15 minutes after birth
Time frame: 15 minutes following cesarean birth
pNN50 is a time-domain HRV measure. It is defined as the percentage of successive NN (normal-to-normal) intervals that differ from each other by more than 50 milliseconds.
12 secondary outcomes
Maternal RMSSD 15 minutes after birth
Time frame: 15 minutes following cesarean birth
Maternal SDNN 15 minutes after birth
Time frame: 15 minutes following cesarean birth
Maternal pNN50 15 minutes after birth
Time frame: 15 minutes following cesarean birth
Neonatal RMSSD 6 hours after birth
Time frame: 6 hours after cesarean birth
Neonatal SDNN 6 hours after birth
Time frame: 6 hours after cesarean birth
Neonatal pNN50 6 hours after birth
Time frame: 6 hours after cesarean birth
Neonatal RMSSD 12 hours after birth
Time frame: 12 hours after cesarean birth
Neonatal SDNN 12 hours after birth
Time frame: 12 hours after cesarean birth
Neonatal pNN50 12 hours after birth
Time frame: 12 hours after cesarean birth
Neonatal RMSSD 24 hours after birth
Time frame: 24 hours after cesarean birth
Neonatal SDNN 24 hours after birth
Time frame: 24 hours after cesarean birth
Neonatal pNN50 24 hours after birth
Time frame: 24 hours after cesarean 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 27 Mar 2026.
- Individual participant dataSharing planned: Undecided. IPD will be stored and shared upon request.
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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 contact and routine care in people with Neonatal Adaptation, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 27 Mar 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 Slovenia. 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 Miha Lucovnik, MD, PhD (+38615229530, miha.lucovnik@kclj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal RMSSD 15 minutes after birth (time frame: 15 minutes following cesarean birth.). The study lists 3 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 27 Mar 2026.