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

Neonatal Hypothermia Clinical Trial

— SCOPRI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03844204
• Other study ID #: 4371/AO
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: February 29, 2020

Study information

• Verified date: April 2020
• Source: University Hospital Padova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 440
• Est. completion date: February 29, 2020
• Est. primary completion date: February 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Minute

Eligibility

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.

Related Conditions & MeSH terms

• Birth Weight
• Hypothermia
• Neonatal Hypothermia

Intervention

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.

Locations

Country	Name	City	State
Italy	University of Padova	Padova

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Padova

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission		30 minutes
Secondary	Proportion of neonates with temperature less than 36.0°C at NICU admission		30 minutes
Secondary	Proportion of neonates with mild hypothermia (temperature 36.0-36.4°C) at NICU admission		30 minutes
Secondary	Proportion of hyperthermic neonates (temperature >38.0°C) at NICU admission		30 minutes
Secondary	Temperature at 1 hour after NICU admission		1 hour
Secondary	Proportion of ineonates with ntraventricular hemorrhage (grade I-IV)		7 days
Secondary	Propoertions of neoantes with respiratory distress syndrome		3 days
Secondary	Proportion of neonates with late onset sepsis		14 days
Secondary	Proportion of neonates with bronchopulmonary dysplasia		36 gestational weeks
Secondary	Proportion of deaths		3 months