Skin to SkinTRANSPAPNEONCT05820386
Skin-to-skin Contact During the Transfer From the Delivery Room to the Neonatal Intensive Care Unit: Impact on Very Preterm Infants and Their Parents
A study testing Skin-to-skin Contact (SSC) and Incubator in people with Skin to Skin and Premature Newborns, run by University Hospital, Tours at 4 sites in France.
Trial summary
Developmental care are recognized as a standard of care for preterm infants in neonatal intensive care units. Regular skin-to skin contacts during the neonatal stay show short and long-term beneficial effects on preterm infants and their parents. Read more about this study
- Who is it for?
- Ages 24 to 34 weeks
- Conditions the study is for
- Skin to Skin, Premature Newborns
- What is being tested?
- Skin-to-skin Contact (SSC) and Incubator
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 4 sitesFrance
- Study dates
- 3 May 2023to 20 Jun 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 24 to 34 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestational age < 34 weeks
- Singleton pregnancy
- Inborn birth, i.e., in the maternity ward of investigating centres
- Need of hospitalization in the neonatal intensive care unit
- Oral and written information of parents and written parental consent to participate in the study (by the father if the mother is unable to participate)
Who cannot join
- Single parent or homosexual couple
- Absence of the father in the delivery room
- Parents not speaking French
- Skin temperature of the newborn < 36°C at the time of randomization
- Conditions not allowing the early skin-to-skin contact: omphalocele, gastroschisis, desquamating dermatological conditions (Harlequin syndrome, Collodion)
- Clinical condition requiring a specific transfer mode according to the pediatrician in the delivery room
- Parents under legal protection
- Minor parents
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Angers
Angers, 49000
Neonatal medicine and intensive care unit, University Hospital, Orléans
Orléans, 45000
Neonatology service, University Hospital, Toulouse
Toulouse, 31300
Neonatal and paediatric service, University Hospital, Tours
Tours, 37000
About this study
Official title: Assessment of Skin-to-skin Contact During the Transfer of Very Preterm Infants From the Delivery Room to the Neonatal Intensive Care Unit : a Randomised Controlled, Non-inferiority, Open-label Trial, in Comparison With Transfer in Incubator
Developmental care are recognized as a standard of care for preterm infants in neonatal intensive care units. Regular skin-to skin contacts during the neonatal stay show short and long-term beneficial effects on preterm infants and their parents. Skin-to-skin contact provides hemodynamic and thermal stability in preterm infants. Regarding parents, skin-to-skin contact sustains the parental bonding, and reduces stress and anxiety related to hospitalization. As a result, early skin-to-skin contact has been associated with an improvement of neurological outcome in very preterm infants.
Thermal stability is crucial during the first hour of life in preterm infants. A temperature at admission in the neonatal intensive care unit below 36.5°C or above 37.2°C has been associated with an increase in neonatal morbidity and mortality.
Read more
Early skin-to-skin contact between a newborn and his/her mother in the delivery room significantly decreases the occurrence of hypothermia below 35.5°C.
The practice of skin-to-skin transfer from the delivery room is emerging in France. Pilot studies have been carried out by French neonatal teams that showed the feasibility of this practice in late-preterm, near-term and term infants. Although skin-to-skin contact routinely involves very preterm infants in neonatal intensive care units worldwide, the feasibility and safety of skin-to-skin contact during the transfer from delivery room to the neonatal unit is poorly documented in very preterm infants. Previous data of our team showed that transfer of preterm infants with non-invasive ventilation using skin-to-skin contact was feasible and safe but concerns emerged about the thermal conservation during the procedure.
The main hypothesis of this study is that skin-to skin contact during the transfer from the delivery room to the neonatal intensive care unit could prevent heat losses in preterm infants as well as the transfer in incubator. Another hypothesis is that very early skin-to-skin contact could positively influence the neonatal course and the parental experience in the neonatal care unit.
- Conditions
- Skin to Skin, Premature Newborns
- Being tested
- Skin-to-skin Contact (SSC), Incubator
- Keywords
- Skin to skin, Premature newborns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin-to-skin Contact (SSC)Procedure or surgery
For the Skin-to-skin Contact (SSC) transfer, the bare-chested father will seat in a wheelchair. Newborns who will wear only a diaper and a cotton cap or noninvasive ventilation headgear will be placed in the kangaroo position against the father's chest to ensure direct contact with the father's skin. Preterm infants with gestational age less than 33 weeks will be wrapped with their father using plastic bags plus warmed cotton towels. More gestationally mature infants will be wrapped with only warmed cotton wraps. The newborn's heart rate, oxygen saturation and skin temperature will be monitored throughout the procedure.
IncubatorProcedure or surgery
In the incubator group, infants will be transferred after resuscitation in an incubator with air temperature set to 36°C. The newborn will be laid on his/her back in a polyethylene bag with a cap. The newborn's heart rate, oxygen saturation and skin temperature will be monitored throughout the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Skin-to-skin contact during the transfer between the delivery room and the neonatal care unit | Experimental | Preterm infants will be transferred using a direct skin-to-skin contact with their father from the delivery room to the intensive neonatal care. Receives: Procedure: Skin-to-skin Contact (SSC) |
| Transfer in incubator between the delivery room and the neonatal care unit | Active comparator | Preterm infants will be transferred in an incubator set to 36°C from the delivery room to the intensive neonatal care. Receives: Procedure: Incubator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the infant skin temperature due to the transfer procedure
Fluctuation in the infant skin temperature between the randomization in the delivery room and the admission in the neonatal intensive care unit (NICU)
Measured: During the transfer procedure
Secondary outcomes (22)
Change in the infant's heart rate during the transfer procedure
Heart rate values during the transfer procedure
Measured: During the transfer procedure
Occurrence of bradycardia episodes in infant during the transfer procedure
Rapid decrease in heart rate less than 100 beats/min that lasts at least 10 secondes during the transfer procedure
Measured: During the transfer procedure
Change in the infant's oxygen saturation during the transfer procedure
Oxygen saturation values during the transfer procedure
Measured: During the transfer procedure
Occurrence of desaturation episodes in infant during the transfer procedure
Decrease in oxygen saturation less than 85% that last at least 10 secondes
Measured: During the transfer procedure
Change in the infant's fraction of inspired oxygen during the transfer procedure
Fraction of inspired oxygen values during the transfer procedure
Measured: During the transfer procedure
Duration of the transfer procedure
Time (in min) during the transfer procedure
Measured: During the transfer procedure
First Hydrogen Potential (pH) of the newborn
First assessment of pH in the neonatal intensive care unit (NICU)
Measured: First blood gas in the NICU
Carbon dioxide partial pressure (pCO2) of the newborn
First assessment of carbon dioxide partial pressure (pCO2) in the neonatal intensive care unit (NICU)
Measured: First blood gas in the NICU
Blood glucose of the newborn
First assessment of blood glucose in the neonatal intensive care unit (NICU)
Measured: First blood glucose measurement in the NICU
Occurence of hypothermia
Decrease of skin temperature less than 36°C
Measured: From admission in the neonatal intensive care unit to 30 min later
Time to the first skin-to-skin contact in the neonatal care unit
Postnatal hour when the first skin-to-skin contact will occur in the neonatal care unit
Measured: Postnatal hour when the first skin-to-skin contact will occur in the neonatal care unit
Practice of skin-to-skin contact in the neonatal intensive care unit (NICU) during the first week of life
Frequency of skin-to-skin contact (Postnatal day and hour), length of each skin-to-skin contact, which parent involves in each skin-to-skin contact episode.
Measured: During the first 7 days of the stay in the neonatal care unit
Quality of parental bond
Assessment through a maternal questionnaire: Mother-to-Infant Bonding Scale (MIBS) questionnaire (Mother-to-infant bonding scale - Taylor, 2005). Only the infant's mother will be invited to fill out this questionnaire.
Measured: 2 time points: i) Between the infant postnatal day 3 and postnatal day 7, and ii) at the infant postnatal day 30 or at the end of the stay in the NICU if this event occur before the postnatal day 30
Parental stress
Parental stress assessed by Perceived Stress Scale (PSS) - Neonatal Intensive Care Unit (NICU) questionnaire (Perceived Stress Scale Neonatal Intensive Care Unit - Miles, 1993). The infant's mother and father will be invited to fill out this questionnaire.
Measured: 2 time points: i) Between the infant postnatal day 3 and postnatal day 7, and ii) at the infant postnatal day 30 or at the end of the stay in the NICU if this event occur before the postnatal day 30
Parental post-traumatic stress disorder
Parental post-traumatic stress disorder assessed by Perinatal Post traumatic stress disorder Questionnaire (PPQ) - DEMIER, 1996). The infant's mother and father will be invited to fill out this questionnaire.
Measured: At the infant postnatal day 30 or at the end of the stay in the NICU if this event occur before the postnatal day 30
Infant growth: Weight
Weight at birth and at the postmenstrual age of 36 weeks
Measured: At birth and weight at the postmenstrual age of 36 weeks
Infant growth: Height
Height at birth and at the postmenstrual age of 36 weeks
Measured: At birth and at the postmenstrual age of 36 weeks
Infant growth: Head circumference
Head circumference at birth and at the postmenstrual age of 36 weeks
Measured: At birth and at the postmenstrual age of 36 weeks
Neonatal morbidity and mortality at the postmenstrual age of 36 weeks
Death
- Intraventricular hemorrhage (maximal grade),
- Periventricular leukomalacia, Necrotizing enterocolitis (> stade 2 of the Bell classification),
- Neonatal surgery,
- Early onset sepsis (onset before postnatal day 2 and > 3 days of intravenous antibiotherapy),
- Late onset sepsis (Blood culture positive, number of events),
- Number of red blood cell transfusions,
- Duration of mechanical ventilation (days).
- Severe bronchopulmonary dysplasia,
- Retinopathy of prematurity that requires laser photocoagulation or intravitreal injection of proangiogenic factor,
- Length of stay in neonatal intensive care unit (days).
Measured: At the postmenstrual age of 36 weeks
Modalities of breastfeeding
First breastfeeding attempt in the neonatal intensive care unit (NICU)
Measured: During the NICU stay: infant postnatal day
Modalities of breastfeeding
Presence of complete or partial breastfeeding at the postmenstrual age of 36 weeks
Measured: At the postmenstrual age of 36 weeks
Mode of infant feeding at the postmenstrual age of 36 weeks
Modes of infant feeding that include breastfeeding, breastmilk given through a bottle, artificial formula
Measured: At the postmenstrual age of 36 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2023
- Study start3 May 2023
- Primary completion10 Mar 2026
- Study completion20 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin to SkinStudies of the same condition, open and under way.
- More trials run by University Hospital, ToursThe 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
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nolwenn CLENET, Study director, University Hospital, Tours
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05820386
- Sponsor's protocol ID
- DR210297
- Acronym
- TRANSPAPNEO
- Status last verified
- Mar 2026
- First submitted
- 23 Mar 2023
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Skin-to-skin Contact During the Transfer of Very Preterm Infants From the Delivery Room to the Neonatal Intensive Care Unit : a Randomised Controlled, Non-inferiority, Open-label Trial, in Comparison With Transfer in Incubator
- ClinicalTrials.gov ID
- NCT05820386
- Acronym / sponsor ID
- TRANSPAPNEO / DR210297
- Conditions
- Skin to Skin, Premature Newborns
- Keywords
- Skin to skin, Premature newborns
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 3 May 2023 (actual)
- Primary completion
- 10 Mar 2026 (actual)
- Study completion
- 20 Jun 2026 (estimated)
- First posted
- 19 Apr 2023 (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.
Developmental care are recognized as a standard of care for preterm infants in neonatal intensive care units. Regular skin-to skin contacts during the neonatal stay show short and long-term beneficial effects on preterm infants and their parents. Skin-to-skin contact provides hemodynamic and thermal stability in preterm infants. Regarding parents, skin-to-skin contact sustains the parental bonding, and reduces stress and anxiety related to hospitalization. As a result, early skin-to-skin contact has been associated with an improvement of neurological outcome in very preterm infants.
Thermal stability is crucial during the first hour of life in preterm infants. A temperature at admission in the neonatal intensive care unit below 36.5°C or above 37.2°C has been associated with an increase in neonatal morbidity and mortality.
Early skin-to-skin contact between a newborn and his/her mother in the delivery room significantly decreases the occurrence of hypothermia below 35.5°C.
The practice of skin-to-skin transfer from the delivery room is emerging in France. Pilot studies have been carried out by French neonatal teams that showed the feasibility of this practice in late-preterm, near-term and term infants. Although skin-to-skin contact routinely involves very preterm infants in neonatal intensive care units worldwide, the feasibility and safety of skin-to-skin contact during the transfer from delivery room to the neonatal unit is poorly documented in very preterm infants. Previous data of our team showed that transfer of preterm infants with non-invasive ventilation using skin-to-skin contact was feasible and safe but concerns emerged about the thermal conservation during the procedure.
The main hypothesis of this study is that skin-to skin contact during the transfer from the delivery room to the neonatal intensive care unit could prevent heat losses in preterm infants as well as the transfer in incubator. Another hypothesis is that very early skin-to-skin contact could positively influence the neonatal course and the parental experience in the neonatal care unit.
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 during the transfer between the delivery room and the neonatal care unit | Experimental | Procedure: Skin-to-skin Contact (SSC)Preterm infants will be transferred using a direct skin-to-skin contact with their father from the delivery room to the intensive neonatal care. |
| Transfer in incubator between the delivery room and the neonatal care unit | Active comparator | Procedure: IncubatorPreterm infants will be transferred in an incubator set to 36°C from the delivery room to the intensive neonatal care. |
Who may qualify
- Ages
- 24 to 34 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Gestational age < 34 weeks
- Singleton pregnancy
- Inborn birth, i.e., in the maternity ward of investigating centres
- Need of hospitalization in the neonatal intensive care unit
- Oral and written information of parents and written parental consent to participate in the study (by the father if the mother is unable to participate)
Key exclusion criteria (8 listed)
- Single parent or homosexual couple
- Absence of the father in the delivery room
- Parents not speaking French
- Skin temperature of the newborn < 36°C at the time of randomization
- Conditions not allowing the early skin-to-skin contact: omphalocele, gastroschisis, desquamating dermatological conditions (Harlequin syndrome, Collodion)
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 Contact (SSC)For the Skin-to-skin Contact (SSC) transfer, the bare-chested father will seat in a wheelchair. Newborns who will wear only a diaper and a cotton cap or noninvasive ventilation headgear will be placed in the kangaroo position against the father's chest to ensure direct contact with the father's skin. Preterm infants with gestational age less than 33 weeks will be wrapped with their father using plastic bags plus warmed cotton towels. More gestationally mature infants will be wrapped with only warmed cotton wraps. The newborn's heart rate, oxygen saturation and skin temperature will be monitored throughout the procedure. | Procedure or surgery | Skin-to-skin contact during the transfer between the delivery room and the neonatal care unit |
| IncubatorIn the incubator group, infants will be transferred after resuscitation in an incubator with air temperature set to 36°C. The newborn will be laid on his/her back in a polyethylene bag with a cap. The newborn's heart rate, oxygen saturation and skin temperature will be monitored throughout the procedure. | Procedure or surgery | Transfer in incubator between the delivery room and the neonatal care unit |
Primary outcome
Change in the infant skin temperature due to the transfer procedure
Time frame: During the transfer procedure
Fluctuation in the infant skin temperature between the randomization in the delivery room and the admission in the neonatal intensive care unit (NICU)
22 secondary outcomes
Change in the infant's heart rate during the transfer procedure
Time frame: During the transfer procedure
Occurrence of bradycardia episodes in infant during the transfer procedure
Time frame: During the transfer procedure
Change in the infant's oxygen saturation during the transfer procedure
Time frame: During the transfer procedure
Occurrence of desaturation episodes in infant during the transfer procedure
Time frame: During the transfer procedure
Change in the infant's fraction of inspired oxygen during the transfer procedure
Time frame: During the transfer procedure
Duration of the transfer procedure
Time frame: During the transfer procedure
First Hydrogen Potential (pH) of the newborn
Time frame: First blood gas in the NICU
Carbon dioxide partial pressure (pCO2) of the newborn
Time frame: First blood gas in the NICU
Blood glucose of the newborn
Time frame: First blood glucose measurement in the NICU
Occurence of hypothermia
Time frame: From admission in the neonatal intensive care unit to 30 min later
Time to the first skin-to-skin contact in the neonatal care unit
Time frame: Postnatal hour when the first skin-to-skin contact will occur in the neonatal care unit
Practice of skin-to-skin contact in the neonatal intensive care unit (NICU) during the first week of life
Time frame: During the first 7 days of the stay in the neonatal care unit
Quality of parental bond
Time frame: 2 time points: i) Between the infant postnatal day 3 and postnatal day 7, and ii) at the infant postnatal day 30 or at the end of the stay in the NICU if this event occur before the postnatal day 30
Parental stress
Time frame: 2 time points: i) Between the infant postnatal day 3 and postnatal day 7, and ii) at the infant postnatal day 30 or at the end of the stay in the NICU if this event occur before the postnatal day 30
Parental post-traumatic stress disorder
Time frame: At the infant postnatal day 30 or at the end of the stay in the NICU if this event occur before the postnatal day 30
Infant growth: Weight
Time frame: At birth and weight at the postmenstrual age of 36 weeks
Infant growth: Height
Time frame: At birth and at the postmenstrual age of 36 weeks
Infant growth: Head circumference
Time frame: At birth and at the postmenstrual age of 36 weeks
Neonatal morbidity and mortality at the postmenstrual age of 36 weeks
Time frame: At the postmenstrual age of 36 weeks
Modalities of breastfeeding
Time frame: During the NICU stay: infant postnatal day
Modalities of breastfeeding
Time frame: At the postmenstrual age of 36 weeks
Mode of infant feeding at the postmenstrual age of 36 weeks
Time frame: At the postmenstrual age of 36 weeks
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 13 Mar 2026.
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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. This study is not recruiting at the moment.
Nolwenn CLENET study director
University Hospital, Tours
4 sites 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 (SSC) and Incubator in people with Skin to Skin and Premature Newborns, run by University Hospital, Tours at 4 sites in France.
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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 13 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 4 sites in France. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the infant skin temperature due to the transfer procedure (time frame: During the transfer procedure). 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 13 Mar 2026.