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

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

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.

Study Overview

• Status: Completed
• Conditions: Neonatal Hypothermia
• Intervention / Treatment: Device: Thermal servo-controlled system

• Study Type: Interventional
• Enrollment (Actual): 440
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Padova, Italy, 35128
    • University of Padova

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 minute to 1 minute (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: No servo-controlled system; The temperature of the infant warmer will be manually set at maximum of power output.	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Hospital Padova

Publications and helpful links

General Publications

• Cavallin F, Doglioni N, Allodi A, Battajon N, Vedovato S, Capasso L, Gitto E, Laforgia N, Paviotti G, Capretti MG, Gizzi C, Villani PE, Biban P, Pratesi S, Lista G, Ciralli F, Soffiati M, Staffler A, Baraldi E, Trevisanuto D; Servo COntrol for PReterm Infants (SCOPRI) Trial Group. Thermal management with and without servo-controlled system in preterm infants immediately after birth: a multicentre, randomised controlled study. Arch Dis Child Fetal Neonatal Ed. 2021 Nov;106(6):572-577. doi: 10.1136/archdischild-2020-320567. Epub 2021 Feb 17.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): February 29, 2020
• Study Completion (Actual): February 29, 2020

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: February 14, 2019
• First Posted (Actual): February 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 3, 2020
• Last Update Submitted That Met QC Criteria: April 2, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Temperature Changes; Birth Weight; Hypothermia
• Other Study ID Numbers: 4371/AO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No