Clinical trial NCT05820386: 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
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Skin to Skin
Premature Newborns
Keywords: Skin to skin
Premature newborns
Lead sponsor: University Hospital, Tours
Sponsor class: OTHER
First posted: 2023-04-19
Enrollment: 118
Sex: ALL
Minimum age (years): 24
Maximum age (years): 34
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the infant skin temperature due to the transfer procedure
timeFrame: During the transfer procedure
Secondary outcomes:
measure: Change in the infant's heart rate during the transfer procedure
timeFrame: During the transfer procedure
measure: Occurrence of bradycardia episodes in infant during the transfer procedure
timeFrame: During the transfer procedure
measure: Change in the infant's oxygen saturation during the transfer procedure
timeFrame: During the transfer procedure
measure: Occurrence of desaturation episodes in infant during the transfer procedure
timeFrame: During the transfer procedure
measure: Change in the infant's fraction of inspired oxygen during the transfer procedure
timeFrame: During the transfer procedure
measure: Duration of the transfer procedure
timeFrame: During the transfer procedure
measure: First Hydrogen Potential (pH) of the newborn
timeFrame: First blood gas in the NICU
measure: Carbon dioxide partial pressure (pCO2) of the newborn
timeFrame: First blood gas in the NICU
measure: Blood glucose of the newborn
timeFrame: First blood glucose measurement in the NICU
measure: Occurence of hypothermia
timeFrame: From admission in the neonatal intensive care unit to 30 min later
measure: Time to the first skin-to-skin contact in the neonatal care unit
timeFrame: Postnatal hour when the first skin-to-skin contact will occur in the neonatal care unit
measure: Practice of skin-to-skin contact in the neonatal intensive care unit (NICU) during the first week of life
timeFrame: During the first 7 days of the stay in the neonatal care unit
measure: Quality of parental bond
timeFrame: 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
measure: Parental stress
timeFrame: 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
measure: Parental post-traumatic stress disorder
timeFrame: 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
measure: Infant growth: Weight
timeFrame: At birth and weight at the postmenstrual age of 36 weeks
measure: Infant growth: Height
timeFrame: At birth and at the postmenstrual age of 36 weeks
measure: Infant growth: Head circumference
timeFrame: At birth and at the postmenstrual age of 36 weeks
measure: Neonatal morbidity and mortality at the postmenstrual age of 36 weeks
timeFrame: At the postmenstrual age of 36 weeks
measure: Modalities of breastfeeding
timeFrame: During the NICU stay: infant postnatal day
measure: Modalities of breastfeeding
timeFrame: At the postmenstrual age of 36 weeks
measure: Mode of infant feeding at the postmenstrual age of 36 weeks
timeFrame: At the postmenstrual age of 36 weeks
Other outcomes:
measure: Self-questionnaires to study parents' experience of their infant hospitalization
timeFrame: 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
Locations:
city: Orléans
country: France
facility: Neonatal medicine and intensive care unit, University Hospital, Orléans
city: Saint-Étienne
country: France
facility: Neonatal intensive care unit, University Hospital, Saint-Etienne
city: Toulouse
country: France
facility: Neonatology service, University Hospital, Toulouse
city: Tours
country: France
facility: Neonatal and paediatric service, University Hospital, Tours
Study officials:
affiliation: University Hospital, Tours
name: Nolwenn CLENET
role: STUDY_DIRECTOR
References: