Archives of disease in childhood. Fetal and neonatal edition · 2021
Thermal management with and without servo-controlled system in preterm infants immediately after birth: a multicentre, randomised controlled study.
СтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Cavallin Francesco, Doglioni Nicoletta, Allodi Alessandra, Battajon Nadia, Vedovato Stefania, Capasso Letizia, Gitto Eloisa, Laforgia Nicola, Paviotti Giulia, Capretti Maria Grazia, Gizzi Camilla, Villani Paolo Ernesto, Biban Paolo, Pratesi Simone, Lista Gianluca, Ciralli Fabrizio, Soffiati Massimo, Staffler Alex, Baraldi Eugenio, Trevisanuto Daniele, Servo COntrol for PReterm Infants (SCOPRI) Trial Group
Аннотация
BACKGROUND: The thermal servo-controlled systems are routinely used in neonatal intensive care units (NICUs) to accurately manage patient temperature, but their role during the immediate postnatal phase has not been previously assessed.
OBJECTIVE: To compare two modalities of thermal management (with and without the use of a servo-controlled system) immediately after birth.
STUDY DESIGN AND SETTING: Multicentre, unblinded, randomised trial conducted 15 Italian tertiary hospitals.
PARTICIPANTS: Infants with estimated birth weight <1500 g and/or gestational age <30+6 weeks.
INTERVENTION: Thermal management with or without a thermal servo-controlled system during stabilisation in the delivery room.
PRIMARY OUTCOME: Proportion of normothermia at NICU admission (axillary temperature 36.5°C-37.5°C).
RESULTS: At NICU admission, normothermia was achieved in 89/225 neonates (39.6%) with the thermal servo-controlled system and 95/225 neonates (42.2%) without the thermal servo-controlled system (risk ratio 0.94, 95% CI 0.75 to 1.17). Thermal servo-controlled system was associated with increased mild hypothermia (36°C-36.4°C) (risk ratio 1.48, 95% CI 1.09 to 2.01).
CONCLUSIONS: In very low birthweight infants, thermal management with the servo-controlled system conferred no advantage in maintaining normothermia at NICU admission, while it was associated with increased mild hypothermia. Thermal management of preterm infants immediately after birth remains a challenge.
TRIAL REGISTRATION NUMBER: NCT03844204.
OBJECTIVE: To compare two modalities of thermal management (with and without the use of a servo-controlled system) immediately after birth.
STUDY DESIGN AND SETTING: Multicentre, unblinded, randomised trial conducted 15 Italian tertiary hospitals.
PARTICIPANTS: Infants with estimated birth weight <1500 g and/or gestational age <30+6 weeks.
INTERVENTION: Thermal management with or without a thermal servo-controlled system during stabilisation in the delivery room.
PRIMARY OUTCOME: Proportion of normothermia at NICU admission (axillary temperature 36.5°C-37.5°C).
RESULTS: At NICU admission, normothermia was achieved in 89/225 neonates (39.6%) with the thermal servo-controlled system and 95/225 neonates (42.2%) without the thermal servo-controlled system (risk ratio 0.94, 95% CI 0.75 to 1.17). Thermal servo-controlled system was associated with increased mild hypothermia (36°C-36.4°C) (risk ratio 1.48, 95% CI 1.09 to 2.01).
CONCLUSIONS: In very low birthweight infants, thermal management with the servo-controlled system conferred no advantage in maintaining normothermia at NICU admission, while it was associated with increased mild hypothermia. Thermal management of preterm infants immediately after birth remains a challenge.
TRIAL REGISTRATION NUMBER: NCT03844204.