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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
440
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.
University of Padova
Padova, Italy
Proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission
Time frame: 30 minutes
Proportion of neonates with temperature less than 36.0°C at NICU admission
Time frame: 30 minutes
Proportion of neonates with mild hypothermia (temperature 36.0-36.4°C) at NICU admission
Time frame: 30 minutes
Proportion of hyperthermic neonates (temperature >38.0°C) at NICU admission
Time frame: 30 minutes
Temperature at 1 hour after NICU admission
Time frame: 1 hour
Proportion of ineonates with ntraventricular hemorrhage (grade I-IV)
Time frame: 7 days
Propoertions of neoantes with respiratory distress syndrome
Time frame: 3 days
Proportion of neonates with late onset sepsis
Time frame: 14 days
Proportion of neonates with bronchopulmonary dysplasia
Time frame: 36 gestational weeks
Proportion of deaths
Time frame: 3 months
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