NCT03844204

Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth

Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth: a Multicenter, Prospective, Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 440 (actual)
• Sponsor: University Hospital Padova · Academic / Other
• Sex: All
• Age: 1 Minute – 1 Minute
• Healthy volunteers: Not accepted

Summary

Hypothermia in preterm infants during the immediate postnatal phase is associated with morbidity and mortality and remains an unresolved, worldwide challenge. A list of interventions, including adequate room temperature, use of infant warmers, polyethylene bags/wrap, pre-heated mattresses, caps and heated and humidified gases, to prevent thermal loss at birth in very preterm infants has been recommended, but a certain percentage of very preterm infants are hypothermic at the time of the neonatal intensive care unit (NICU) admission suggesting that further measures are needed. The thermal servo-controlled systems are routinely used in the NICU to accurately manage the patients' temperature, but their role during the immediate postnatal phase has not been previously assessed. We hypothesized that using a thermal servo-control system at delivery could prevent heat loss during this delicate phase and increase the percentage of very low birth weight infants (VLBWI) in the normal thermal range (temperature 36.5-37.5°C) at NICU admission. The aim of this study will be to compare two modes of thermal management (with and without the use of a thermal servo-controlled system) for preventing heat loss at birth in VLBWI infants.

Conditions

• Neonatal Hypothermia

Interventions

Type	Name	Description
DEVICE	Thermal servo-controlled system	All patients will be positioned under the infant warmer. In the treatment group, a probe positioned on the skin of the neonate will guide the thermal exposure in a servo-controlled modality. In the control group, thermal exposure will be determined manually by setting the power of the heater at the maximum output.

Timeline

• Start date: 2019-03-01
• Primary completion: 2020-02-29
• Completion: 2020-02-29
• First posted: 2019-02-18
• Last updated: 2020-04-03

Locations

1 site across 1 country: Italy