Clinical trial NCT03844204: Effect of a Servo-control System on Heat Loss in Very Low Birth Weight Infants at Birth
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Hypothermia
Lead sponsor: University Hospital Padova
Sponsor class: OTHER
First posted: 2019-02-18
Enrollment: 440
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of neonates in the normal thermal range (temperature 36.5-37.5°C) at NICU admission
timeFrame: 30 minutes
Secondary outcomes:
measure: Proportion of neonates with temperature less than 36.0°C at NICU admission
timeFrame: 30 minutes
measure: Proportion of neonates with mild hypothermia (temperature 36.0-36.4°C) at NICU admission
timeFrame: 30 minutes
measure: Proportion of hyperthermic neonates (temperature >38.0°C) at NICU admission
timeFrame: 30 minutes
measure: Temperature at 1 hour after NICU admission
timeFrame: 1 hour
measure: Proportion of ineonates with ntraventricular hemorrhage (grade I-IV)
timeFrame: 7 days
measure: Propoertions of neoantes with respiratory distress syndrome
timeFrame: 3 days
measure: Proportion of neonates with late onset sepsis
timeFrame: 14 days
measure: Proportion of neonates with bronchopulmonary dysplasia
timeFrame: 36 gestational weeks
measure: Proportion of deaths
timeFrame: 3 months
Other outcomes:
Locations:
city: Padova
country: Italy
facility: University of Padova
Study officials:
References:
citation: 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.