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
NCT ID: NCT05820386
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
118 participants
INTERVENTIONAL
2023-05-03
2027-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Skin-to-skin contact during the transfer between the delivery room and the neonatal care unit
Preterm infants will be transferred using a direct skin-to-skin contact with their father from the delivery room to the intensive neonatal care.
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.
Transfer in incubator between the delivery room and the neonatal care unit
Preterm infants will be transferred in an incubator set to 36°C from the delivery room to the intensive neonatal care.
Incubator
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.
Interventions
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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.
Incubator
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.
Eligibility Criteria
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Inclusion Criteria
* 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)
Exclusion Criteria
* 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
24 Weeks
34 Weeks
ALL
No
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Nolwenn CLENET
Role: STUDY_DIRECTOR
University Hospital, Tours
Locations
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CHU Angers
Angers, , France
Neonatal medicine and intensive care unit, University Hospital, Orléans
Orléans, , France
Neonatal intensive care unit, University Hospital, Saint-Etienne
Saint-Etienne, , France
Neonatology service, University Hospital, Toulouse
Toulouse, , France
Neonatal and paediatric service, University Hospital, Tours
Tours, , France
Countries
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Central Contacts
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Facility Contacts
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Benjamine HARDY
Role: primary
Marine RICHE
Role: primary
Mélinda BENARD
Role: primary
Nolwenn CLENET
Role: primary
Other Identifiers
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DR210297
Identifier Type: -
Identifier Source: org_study_id