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ACTIVE NOT RECRUITING
NCT05820386
NA

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

Sponsor: University Hospital, Tours

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

24 Weeks - 34 Weeks

Study Type

INTERVENTIONAL

Enrollment

118

Start Date

2023-05-03

Completion Date

2026-06-20

Last Updated

2026-03-13

Healthy Volunteers

No

Interventions

PROCEDURE

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

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.

Locations (4)

CHU Angers

Angers, France

Neonatal medicine and intensive care unit, University Hospital, Orléans

Orléans, France

Neonatology service, University Hospital, Toulouse

Toulouse, France

Neonatal and paediatric service, University Hospital, Tours

Tours, France