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)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Premature Newborns; Skin to Skin
• Intervention / Treatment: Procedure: Skin-to-skin Contact (SSC); Procedure: Incubator

• Study Type: Interventional
• Enrollment (Anticipated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nolwenn CLENET; Phone Number: +33 02 47 47 47 49; Email: N.CLENET@chu-tours.fr

Study Locations

• France
  • Orléans, France, 45000
    • Neonatal medicine and intensive care unit, University Hospital, Orléans
    • Contact: Marine RICHE
    • Principal Investigator: Marine RICHE
  • Saint-Étienne, France, 42055
    • Neonatal intensive care unit, University Hospital, Saint-Etienne
    • Contact: Corinne VRAY
    • Principal Investigator: Corinne VRAY
  • Toulouse, France, 31300
    • Neonatology service, University Hospital, Toulouse
    • Contact: Lauriane PARDO
    • Principal Investigator: Lauriane PARDO
  • Tours, France, 37000
    • Neonatal and paediatric service, University Hospital, Tours
    • Contact: Nolwenn CLENET; Email: N.CLENET@chu-tours.fr
    • Principal Investigator: Nolwenn CLENET

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Skin-to-skin contact during the transfer between the delivery room and the neonatal care unit; 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); 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.
Active Comparator: Transfer in incubator between the delivery room and the neonatal care unit; Preterm infants will be transferred in an incubator set to 36°C from the delivery room to the intensive neonatal care.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the infant's heart rate during the transfer procedure	Heart rate values during the transfer procedure	During the transfer procedure
Occurrence of bradycardia episodes in infant during the transfer procedure	Rapid decrease in heart rate less than 100 beats/min that lasts at least 10 secondes during the transfer procedure	During the transfer procedure
Change in the infant's oxygen saturation during the transfer procedure	Oxygen saturation values during the transfer procedure	During the transfer procedure
Occurrence of desaturation episodes in infant during the transfer procedure	Decrease in oxygen saturation less than 85% that last at least 10 secondes	During the transfer procedure
Change in the infant's fraction of inspired oxygen during the transfer procedure	Fraction of inspired oxygen values during the transfer procedure	During the transfer procedure
Duration of the transfer procedure	Time (in min) during the transfer procedure	During the transfer procedure
First Hydrogen Potential (pH) of the newborn	First assessment of pH in the neonatal intensive care unit (NICU)	First blood gas in the NICU
Carbon dioxide partial pressure (pCO2) of the newborn	First assessment of carbon dioxide partial pressure (pCO2) in the neonatal intensive care unit (NICU)	First blood gas in the NICU
Blood glucose of the newborn	First assessment of blood glucose in the neonatal intensive care unit (NICU)	First blood glucose measurement in the NICU
Occurence of hypothermia	Decrease of skin temperature less than 36°C	From admission in the neonatal intensive care unit to 30 min later
Time to the first skin-to-skin contact in the neonatal care unit	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
Practice of skin-to-skin contact in the neonatal intensive care unit (NICU) during the first week of life	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.	During the first 7 days of the stay in the neonatal care unit
Quality of parental bond	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.	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	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.	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 post-traumatic stress disorder	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.	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
Infant growth: Weight	Weight at birth and at the postmenstrual age of 36 weeks	At birth and weight at the postmenstrual age of 36 weeks
Infant growth: Height	Height at birth and at the postmenstrual age of 36 weeks	At birth and at the postmenstrual age of 36 weeks
Infant growth: Head circumference	Head circumference at birth and at the postmenstrual age of 36 weeks	At birth and at the postmenstrual age of 36 weeks
Neonatal morbidity and mortality 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).	At the postmenstrual age of 36 weeks
Modalities of breastfeeding	First breastfeeding attempt in the neonatal intensive care unit (NICU)	During the NICU stay: infant postnatal day
Modalities of breastfeeding	Presence of complete or partial breastfeeding at the postmenstrual age of 36 weeks	At the postmenstrual age of 36 weeks
Mode of infant feeding at the postmenstrual age of 36 weeks	Modes of infant feeding that include breastfeeding, breastmilk given through a bottle, artificial formula	At the postmenstrual age of 36 weeks

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Tours
• Investigators: Study Director: Nolwenn CLENET, University Hospital, Tours

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2025
• Study Completion (Anticipated): August 1, 2025

Study Registration Dates

• First Submitted: March 23, 2023
• First Submitted That Met QC Criteria: April 6, 2023
• First Posted (Actual): April 19, 2023

Study Record Updates

• Last Update Posted (Actual): April 19, 2023
• Last Update Submitted That Met QC Criteria: April 6, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Skin to skin; Premature newborns
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Premature Birth
• Other Study ID Numbers: DR210297

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No