Neonatal Hypothermia
Conditions
Brief 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.
Interventions
DEVICEThermal 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.
Sponsors
University Hospital Padova
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
Nurses who will measure the temperature at NICU admission are blind to treatment arm in the delivery room
Eligibility
Sex/Gender
ALL
Age
1 Minutes to 1 Minutes
Healthy volunteers
No
Inclusion criteria
1. Estimated birth weight \<1500 g and/or gestational age \<30+6 weeks (and) 2. Inborn (and) 3. Parental consent
Exclusion criteria
1. Major congenital malformations (i.e. cardiac disease, defects of abdominal wall, ...); 2. Outborn; 3. Parental refusal to participate to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission | 30 minutes |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of neonates with mild hypothermia (temperature 36.0-36.4°C) at NICU admission | 30 minutes |
| Proportion of hyperthermic neonates (temperature >38.0°C) at NICU admission | 30 minutes |
| Temperature at 1 hour after NICU admission | 1 hour |
| Proportion of ineonates with ntraventricular hemorrhage (grade I-IV) | 7 days |
| Proportion of neonates with temperature less than 36.0°C at NICU admission | 30 minutes |
| Proportion of neonates with late onset sepsis | 14 days |
| Proportion of neonates with bronchopulmonary dysplasia | 36 gestational weeks |
| Proportion of deaths | 3 months |
| Propoertions of neoantes with respiratory distress syndrome | 3 days |
Countries
Italy
Outcome results
None listed