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

Not Applicable

Completed

• Conditions: Neonatal Hypothermia
• Interventions: Device: Thermal servo-controlled system

• Registration Number: NCT03844204
• Lead Sponsor: University Hospital Padova

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-02-14
• Study First Posted: 2019-02-18
• Study Start: 2019-03-01
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29
• Status Verified: 2020-04
• Last Update Submitted: 2020-04-02
• Last Update Posted: 2020-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 440

Inclusion Criteria

1. Estimated birth weight <1500 g and/or gestational age <30+6 weeks (and)
2. Inborn (and)
3. Parental consent

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Exclusion Criteria

1. Major congenital malformations (i.e. cardiac disease, defects of abdominal wall, ...);
2. Outborn;
3. Parental refusal to participate to the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No servo-controlled system	Thermal servo-controlled system	The temperature of the infant warmer will be manually set at maximum of power output.
Servo-controlled system	Thermal 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.

Primary Outcome Measures

Name	Time	Method
Proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission	30 minutes

Secondary Outcome Measures

Name	Time	Method
Proportion of neonates with mild hypothermia (temperature 36.0-36.4°C) at NICU admission	30 minutes
Propoertions of neoantes with respiratory distress syndrome	3 days
Proportion of hyperthermic neonates (temperature >38.0°C) at NICU admission	30 minutes
Proportion of ineonates with ntraventricular hemorrhage (grade I-IV)	7 days
Proportion of deaths	3 months
Proportion of neonates with temperature less than 36.0°C at NICU admission	30 minutes
Temperature at 1 hour after NICU admission	1 hour
Proportion of neonates with late onset sepsis	14 days
Proportion of neonates with bronchopulmonary dysplasia	36 gestational weeks

Trial Locations

Locations (1)

University of Padova; 🇮🇹 Padova, Italy