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
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Collaborators The SCOPRI-TRIAL Group includes: Francesco Raimondi (Napoli), Petrina Bastrenta (Milano), Manuela Capozza (Bari), Silvia Del Torre (Udine), Valentina Favero (Treviso), Silvia Lama (Milano), Michele Luzzati (Firenze), Concetta Marsico (Bologna), Irene Sibona (Verona), Sonia Rico' (Brescia) and Petra Wanker (Bolzano).
Contributors FrC was responsible for the statistical design and analysis, data interpretation and writing of the manuscript. ND contributed to study design, coordinated and supervised data collection and critically reviewed the manuscript. AA contributed to study design, protocol preparation and submission to ethics committees, and critically reviewed the manuscript. NB, SV, LC, EG, NL, GP, MGC, PE, CG, PB, SP, GL, FaC, MS and AS contributed to study design, performed data collection and critically reviewed the manuscript. EB contributed to study design, data interpretation and critically reviewed the manuscript. DT conceived the study, contributed to study design, data interpretation and writing of the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The Ethics Committees of the participating centres approved the trial protocol (coordinating centre: Comitato Etico per la Sperimentazione Clinica della Provincia di Padova. N. 4371/AO/17).
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available on reasonable request. Data are available on reasonable request to the corresponding author.
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