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

University Hospital Padova

Status: Completed

Conditions: Neonatal Hypothermia

Treatments: Device: Thermal servo-controlled system

Study type: Interventional

Funder types: Other

Identifiers

NCT03844204

4371/AO

Details and patient eligibility

About

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.

Enrollment: 440 patients

Sex: All

Ages: 1 to 1 minute old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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440 participants in 2 patient groups

Servo-controlled system

Experimental group

Description:

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.

Treatment:

Device: Thermal servo-controlled system

No servo-controlled system

Active Comparator group

Description:

The temperature of the infant warmer will be manually set at maximum of power output.

Treatment:

Device: Thermal servo-controlled system