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

Study Overview
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Brief Summary
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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.

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

Conditions
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Neonatal Hypothermia

Intervention / Treatment
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* Device: Thermal servo-controlled system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Estimated birth weight <1500 g and/or gestational age <30+6 weeks (and) Inborn (and) Parental consent Exclusion Criteria: Major congenital malformations (i.e. cardiac disease, defects of abdominal wall, ...); Outborn; Parental refusal to participate to the study.

Ages Eligible for Study
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Minimum Age: 1 Minute
Maximum Age: 1 Minute

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Servo-controlled system<br>The temperature probe of the servo-controlled system will be positioned on the patient's abdomen with an adhesive tape. The body temperature will be set at 37°C. | Device: Thermal servo-controlled system<br>* 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.<br>|
| Active Comparator: No servo-controlled system<br>The temperature of the infant warmer will be manually set at maximum of power output. | Device: Thermal servo-controlled system<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission |  | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of neonates with temperature less than 36.0°C at NICU admission |  | 30 minutes | 
| 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 | 
| Propoertions of neoantes with respiratory distress syndrome |  | 3 days | 
| Proportion of neonates with late onset sepsis |  | 14 days | 
| Proportion of neonates with bronchopulmonary dysplasia |  | 36 gestational weeks | 
| Proportion of deaths |  | 3 months |