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NCT Number: 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

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.

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Key information

Conditions

Skin to Skin Premature Newborns

Age range

24 week–34 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Angers, Angers, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in the infant skin temperature due to the transfer procedure

    Time frame: During 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)

Secondary outcomes

  1. Change in the infant's heart rate during the transfer procedure

    Time frame: During the transfer procedure

    Heart rate values during the transfer procedure

  2. Occurrence of bradycardia episodes in infant during the transfer procedure

    Time frame: During the transfer procedure

    Rapid decrease in heart rate less than 100 beats/min that lasts at least 10 secondes during the transfer procedure

  3. Change in the infant's oxygen saturation during the transfer procedure

    Time frame: During the transfer procedure

    Oxygen saturation values during the transfer procedure

  4. Occurrence of desaturation episodes in infant during the transfer procedure

    Time frame: During the transfer procedure

    Decrease in oxygen saturation less than 85% that last at least 10 secondes

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

    Time frame: During the transfer procedure

    Fraction of inspired oxygen values during the transfer procedure

  6. Duration of the transfer procedure

    Time frame: During the transfer procedure

    Time (in min) during the transfer procedure

  7. First Hydrogen Potential (pH) of the newborn

    Time frame: First blood gas in the NICU

    First assessment of pH in the neonatal intensive care unit (NICU)

  8. Carbon dioxide partial pressure (pCO2) of the newborn

    Time frame: First blood gas in the NICU

    First assessment of carbon dioxide partial pressure (pCO2) in the neonatal intensive care unit (NICU)

  9. Blood glucose of the newborn

    Time frame: First blood glucose measurement in the NICU

    First assessment of blood glucose in the neonatal intensive care unit (NICU)

  10. Occurence of hypothermia

    Time frame: From admission in the neonatal intensive care unit to 30 min later

    Decrease of skin temperature less than 36°C

  11. Time to the first skin-to-skin contact in the neonatal care unit

    Time frame: Postnatal hour when the first skin-to-skin contact will occur in the neonatal care unit

    Postnatal hour when the first skin-to-skin contact will occur in the neonatal care unit

  12. Practice of skin-to-skin contact in the neonatal intensive care unit (NICU) during the first week of life

    Time frame: During the first 7 days of the stay in the neonatal care unit

    Frequency of skin-to-skin contact (Postnatal day and hour), length of each skin-to-skin contact, which parent involves in each skin-to-skin contact episode.

  13. Quality of parental bond

    Time frame: 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

    Assessment through a maternal questionnaire: Mother-to-Infant Bonding Scale (MIBS) questionnaire (Mother-to-infant bonding scale - Taylor, 2005). Only the infant's mother will be invited to fill out this questionnaire.

  14. Parental stress

    Time frame: 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

    Parental stress assessed by Perceived Stress Scale (PSS) - Neonatal Intensive Care Unit (NICU) questionnaire (Perceived Stress Scale Neonatal Intensive Care Unit - Miles, 1993). The infant's mother and father will be invited to fill out this questionnaire.

  15. Parental post-traumatic stress disorder

    Time frame: 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

    Parental post-traumatic stress disorder assessed by Perinatal Post traumatic stress disorder Questionnaire (PPQ) - DEMIER, 1996). The infant's mother and father will be invited to fill out this questionnaire.

  16. Infant growth: Weight

    Time frame: At birth and weight at the postmenstrual age of 36 weeks

    Weight at birth and at the postmenstrual age of 36 weeks

  17. Infant growth: Height

    Time frame: At birth and at the postmenstrual age of 36 weeks

    Height at birth and at the postmenstrual age of 36 weeks

  18. Infant growth: Head circumference

    Time frame: At birth and at the postmenstrual age of 36 weeks

    Head circumference at birth and at the postmenstrual age of 36 weeks

  19. Neonatal morbidity and mortality at the postmenstrual age of 36 weeks

    Time frame: At the postmenstrual age of 36 weeks

    Death

    • Intraventricular hemorrhage (maximal grade),
    • Periventricular leukomalacia, Necrotizing enterocolitis (> stade 2 of the Bell classification),
    • Neonatal surgery,
    • Early onset sepsis (onset before postnatal day 2 and > 3 days of intravenous antibiotherapy),
    • Late onset sepsis (Blood culture positive, number of events),
    • Number of red blood cell transfusions,
    • Duration of mechanical ventilation (days).
    • Severe bronchopulmonary dysplasia,
    • Retinopathy of prematurity that requires laser photocoagulation or intravitreal injection of proangiogenic factor,
    • Length of stay in neonatal intensive care unit (days).

  20. Modalities of breastfeeding

    Time frame: During the NICU stay: infant postnatal day

    First breastfeeding attempt in the neonatal intensive care unit (NICU)

  21. Modalities of breastfeeding

    Time frame: At the postmenstrual age of 36 weeks

    Presence of complete or partial breastfeeding at the postmenstrual age of 36 weeks

  22. Mode of infant feeding at the postmenstrual age of 36 weeks

    Time frame: At the postmenstrual age of 36 weeks

    Modes of infant feeding that include breastfeeding, breastmilk given through a bottle, artificial formula

Other outcomes

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

    Time frame: 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

    Ancillary study: Self-questionnaires to study parents' experience of their infant hospitalization to assess stress at different times.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study 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

Acronym: TRANSPAPNEO

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Apr 19, 2023
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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