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 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118
Last updated 2026-03-13
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
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.
Sponsors & Collaborators
-
University Hospital, Tours
lead OTHER
Principal Investigators
-
Nolwenn CLENET · University Hospital, Tours
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 24 Weeks
- Max Age
- 34 Weeks
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-05-03
- Primary Completion
- 2026-03-10
- Completion
- 2026-06-20
Countries
- France
Study Locations
More Related Trials
-
Air vs. Cutaneous Control Mode for Preterm Infants ≤ 32 WG in Incubators: Impact on Body Growth and Morbidity
NCT03919188 ·Status: RECRUITING ·Phase: NA
-
Effect of Skin-to-skin Contact on Interaction and Parents' Sleep
NCT03004677 ·Status: TERMINATED ·Phase: NA
-
Skin-to-skin Contact in Healthy Term Infants
NCT06777524 ·Status: RECRUITING ·Phase: NA
-
Safety of Immediate Skin-to-Skin Contact After Vaginal Birth in Vigorous Late-Preterm Neonates
NCT03585192 ·Status: TERMINATED ·Phase: NA
-
Skin-to-skin Contact in Neonatal Intensive Care Unit (NICU), Caregiving Touch and Neural Correlates of Slow Stroking Touch in Preterm Infants
NCT04293939 ·Status: RECRUITING
-
Skin-to-skin Contact to Promote Bacterial Decolonization in Preterm Infants
NCT01498133 ·Status: UNKNOWN ·Phase: PHASE2
-
Immediate Skin-To-Skin Care For Preterm Infants After Birth
NCT06794164 ·Status: RECRUITING ·Phase: NA
-
Effects of Mother Position in Skin-to-skin Contact Newborn on Oxygen Saturation Levels.
NCT02585492 ·Status: COMPLETED ·Phase: NA
-
Impact of Standardized Skin-to-Skin Care on Clinical Outcomes in Infants Born ≤ 32 Weeks: A Multicenter Study
NCT06672913 ·Status: RECRUITING ·Phase: NA
-
Management and Thermal Comfort of Premature Infants Under 32 Weeks
NCT03648606 ·Status: COMPLETED
-
Comparison of Two Different Skin-to-skin Contact Techniques: Sustained Diagonal Flexion vs. Traditional
NCT06154148 ·Status: RECRUITING ·Phase: NA
-
A Pilot Randomized Controlled Trial of the Effects of Daily Skin-to-skin Contact (PRCTS2S)
NCT04368767 ·Status: COMPLETED ·Phase: NA
-
Preterm DElayed Cord Clamping and Early Skin-to-Skin Contact: PreDECESS
NCT05709392 ·Status: RECRUITING ·Phase: NA
-
Monitoring of Vital Signs During Skin-to-skin Holding by Mothers of Their Preterm Babies
NCT02231801 ·Status: COMPLETED
-
Intervention Facilitates Oral Feeding in Premature Infants
NCT04283682 ·Status: COMPLETED ·Phase: NA
-
Efficacy of a Scarf to Facilitate Mother-newborn Contact Designed to Facilitate Skin-to-skin Contact
NCT04881071 ·Status: COMPLETED ·Phase: NA
-
The Effect Of Therapeutic Touch To Mothers With Preterm Babies
NCT04122417 ·Status: COMPLETED
-
Evaluation of Risk Factors Predictive of Hypothermia in Preterm Neonates in Incubators During the First Week of Life
NCT02803606 ·Status: COMPLETED
-
Tandem: Skin-to-skin Transfer From the Delivery Room to the Neonatal Unit
NCT06198478 ·Status: COMPLETED
-
Family Integrated Care in the NICU
NCT01852695 ·Status: UNKNOWN ·Phase: NA
-
Impact of Parent's Presence in Neonatology
NCT03344939 ·Status: COMPLETED
-
Early Skin to Skin in Neonatal Reanimation
NCT03171844 ·Status: COMPLETED ·Phase: NA
-
Evaluation of a Sensory-tonic Stimulation on Development of Parent-infant Interactions and Social Cognition in Very Premature Children
NCT04380051 ·Status: RECRUITING ·Phase: NA
-
Reading Stories to Premature Babies Reinforces Mother-baby Synchronies?
NCT03114644 ·Status: UNKNOWN ·Phase: NA
-
Very Low Birth Weight Preterm Infant Bundled Care in the NICU
NCT03370757 ·Status: COMPLETED ·Phase: NA