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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-02-29

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.

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Detailed Description

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Conditions

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Neonatal Hypothermia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Nurses who will measure the temperature at NICU admission are blind to treatment arm in the delivery room

Study Groups

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Servo-controlled system

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.

Group Type EXPERIMENTAL

Thermal servo-controlled system

Intervention Type DEVICE

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.

No servo-controlled system

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

Group Type ACTIVE_COMPARATOR

Thermal servo-controlled system

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

1 Minute

Maximum Eligible Age

1 Minute

Eligible Sex

ALL

Accepts Healthy Volunteers

No