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

NCT05820386 | Active Not Recruiting

• 1 other identifier: DR210297
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Skin to Skin; Premature Newborns

Keywords

Skin to skin; Premature newborns

Outcome Measures

Primary Outcomes (1)

• 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)

  During the transfer procedure

Secondary Outcomes (22)

• Change in the infant's heart rate during the transfer procedure

  During the transfer procedure

• Occurrence of bradycardia episodes in infant during the transfer procedure

  During the transfer procedure

• Change in the infant's oxygen saturation during the transfer procedure

  During the transfer procedure

• Occurrence of desaturation episodes in infant during the transfer procedure

  During the transfer procedure

• Change in the infant's fraction of inspired oxygen during the transfer procedure

  During the transfer procedure

Other Outcomes (1)

• Self-questionnaires to study parents' experience of their infant hospitalization

  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

Study Arms (2)

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.

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.

Procedure: Incubator

Interventions

Skin-to-skin Contact (SSC) PROCEDURE

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.

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

Incubator PROCEDURE

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.

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

Eligibility Criteria

• Age: 24 Weeks - 34 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (4)

CHU Angers

Angers, 49000, France

Location

Neonatal medicine and intensive care unit, University Hospital, Orléans

Orléans, 45000, France

Location

Neonatology service, University Hospital, Toulouse

Toulouse, 31300, France

Location

Neonatal and paediatric service, University Hospital, Tours

Tours, 37000, France

Location

MeSH Terms

Interventions

Incubators

Intervention Hierarchy (Ancestors)

Equipment and Supplies

Study Officials

• Nolwenn CLENET

  University Hospital, Tours

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2023
• First Posted: April 19, 2023
• Study Start: May 3, 2023
• Primary Completion: March 10, 2026
• Study Completion (Estimated): June 20, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

FR (4)