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 (TRANSPAPNEO)

Regional University Hospital Center (CHRU)

Status: Enrolling

Conditions: Skin to Skin; Premature Newborns

Treatments: Procedure: Incubator; Procedure: Skin-to-skin Contact (SSC)

Study type: Interventional

Funder types: Other

Identifiers

NCT05820386

DR210297

Details and patient eligibility

About

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.

Enrollment: 118 estimated patients

Sex: All

Ages: 24 to 34 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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)

Exclusion criteria

• 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 design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

Skin-to-skin contact during the transfer between the delivery room and the neonatal care unit

Experimental group

Description:

Preterm infants will be transferred using a direct skin-to-skin contact with their father from the delivery room to the intensive neonatal care.

Treatment:

Procedure: Skin-to-skin Contact (SSC)

Transfer in incubator between the delivery room and the neonatal care unit

Active Comparator group

Description:

Preterm infants will be transferred in an incubator set to 36°C from the delivery room to the intensive neonatal care.

Treatment:

Procedure: Incubator