Thermal management with and without servo-controlled system in preterm infants immediately after birth: a multicentre, randomised controlled study.

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 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.