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Original research
Thermal management with and without servo-controlled system in preterm infants immediately after birth: a multicentre, randomised controlled study
  1. Francesco Cavallin1,
  2. Nicoletta Doglioni2,
  3. Alessandra Allodi3,
  4. Nadia Battajon4,
  5. Stefania Vedovato5,
  6. Letizia Capasso6,
  7. Eloisa Gitto7,
  8. Nicola Laforgia8,
  9. Giulia Paviotti9,
  10. Maria Grazia Capretti10,
  11. Camilla Gizzi11,
  12. Paolo Ernesto Villani12,
  13. Paolo Biban13,
  14. Simone Pratesi14,
  15. Gianluca Lista15,
  16. Fabrizio Ciralli16,
  17. Massimo Soffiati17,
  18. Alex Staffler18,
  19. Eugenio Baraldi2,
  20. Daniele Trevisanuto2
  21. on behalf of Servo COntrol for PReterm Infants (SCOPRI) Trial Group
    1. 1 Independent statistician, Solagna, Italy
    2. 2 Department of Woman and Child Health, University Hospital of Padova, Padova, Italy
    3. 3 Pediatric Department, Ospedale San Martino, Genova, Italy
    4. 4 Pediatric Department, Ospedale Regionale Ca Foncello Treviso, Treviso, Veneto, Italy
    5. 5 Pediatric Department, Ospedale San Bortolo di Vicenza, Vicenza, Veneto, Italy
    6. 6 Translational Medical Sciences, University “Federico II”, Napoli, Italy
    7. 7 Department of Pediatrics, University of Messina, Neonatal Intensive Care Unit, Messina, Italy
    8. 8 A.O.U.C.Policlinico, Neonatologia e T.I.N, Bari, Italy
    9. 9 Department of Neonatology, Azienda Ospedaliera Universitaria Integrata di Udine, Udine, Italy
    10. 10 Department of Medical and Surgical Sciences, Operative Unit of Neonatology, University of Bologna, Bologna, Italy
    11. 11 NICU, "S. Giovanni Calibita" Hospital – Fatebenefratelli Isola Tiberina, Rome, Italy
    12. 12 Department of Pediatrics, Fondazione Poliambulanza, Brescia, Italy
    13. 13 Department of Pediatrics, PICU-NICU, University Hospital of Verona, Verona, Italy
    14. 14 Division of Neonatology, Careggi University Hospital, Florence, Italy
    15. 15 Department of Pediatrics, Ospedale dei Bambini “V.Buzzi”, Milano, Italy
    16. 16 Dipartimento Donna-Bambino-Neonato, Ospedale Maggiore Policlinico, Milano, Lombardia, Italy
    17. 17 Division of Pediatrics, S. Chiara General Hospital, Azienda Provinciale per i Servizi Sanitari, Trento, Trentino-Alto Adige, Italy
    18. 18 Division of Neonatology, Azienda Sanitaria dell’Alto Adige di Bolzano, Bolzano, Italy
    1. Correspondence to Dr Daniele Trevisanuto, Department of Woman's and Child's Health, University of Padova, Universita degli Studi di Padova Dipartimento di Salute della Donna e del Bambino, 35128 Padova, Italy; daniele.trevisanuto{at}gmail.com

    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

    • neonatology
    • resuscitation

    https://doi.org/10.1136/archdischild-2020-320567

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      Footnotes

      • Twitter @nbattajon@gmail.com

      • Correction notice This paper has been updated since it was published online. The affiliation of author Giulia Paviotti has been changed to Department of Neonatology, Azienda Ospedaliera Universitaria Integrata di Udine, Udine, Italy.

      • 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.

      • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.

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