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 Feb 17;fetalneonatal-2020-320567. doi: 10.1136/archdischild-2020-320567. Online ahead of print.

Abstract

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.

Keywords: neonatology; resuscitation.

Associated data

  • ClinicalTrials.gov/NCT03844204