A multi-centre randomised controlled trial of respiratory function monitoring during stabilisation of very preterm infants at birth

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Article

van Zanten, Henriette A.¹  Kuypers, Kristel L. A. M.¹  van Zwet, Erik W.²  van Vonderen, Jeroen J.¹  Kamlin, C. Omar F.³  Springer, Laila⁴  Lista, Gianluca⁵  Cavigioli, Francesco⁵  Vento, Maximo⁶  Nunez-Ramiro, Antonio⁶  Oberthuer, Andre⁷  Kribs, Angela⁷  Kuester, Helmut⁸  Horn, Sebastian⁸  Weinberg, Danielle D.⁹  Foglia, Elizabeth E.⁹  Morley, Colin J.¹⁰  Davis, Peter G.³  te Pas, Arjan B.¹ 

[1] Leiden Univ, Med Ctr, Dept Paediat, Div Neonatol, Leiden, Netherlands

[2] Leiden Univ, Med Ctr, Dept Biomed Data Sci, Leiden, Netherlands

[3] Univ Melbourne, Royal Womens Hosp, Melbourne, Vic, Australia

[4] Univ Childrens Hosp, Dept Neonatol, Tubingen, Germany

[5] ASST FBF Sacco, V Buzzi Childrens Hosp, Dept Neonatol, Milan, Italy

[6] Univ & Polytech Hosp La Fe, Div Neonatol, Valencia, Spain

[7] Univ Cologne, Dept Neonatol, Cologne, Germany

[8] Univ Med Gottingen, Neonatol, Gottingen, Niedersachsen, Germany

[9] Univ Penn, Perelman Sch Med, Dept Pediat, Div Neonatol, Philadelphia, PA 19104 USA

[10] Univ Cambridge, Dept Obstet & Gynaecol, Cambridge, England

关键词: Neonatal resuscitation;    Preterm infants;    Respiration;    Monitoring;    Tidal volume;   

DOI  :  10.1016/j.resuscitation.2021.07.012

来源: Elsevier

【 摘 要 】

Aim: To determine whether the use of a respiratory function monitor (RFM) during PPV of extremely preterm infants at birth, compared with no RFM, leads to an increase in percentage of inflations with an expiratory tidal volume (Vte) within a predefined target range. Methods: Unmasked, randomised clinical trial conducted October 2013 - May 2019 in 7 neonatal intensive care units in 6 countries. Very preterm infants (24-27 weeks of gestation) receiving PPV at birth were randomised to have a RFM screen visible or not. The primary outcome was the median proportion of inflations during manual PPV (face mask or intubated) within the target range (Vte 4-8 mL/kg). There were 42 other prespecified monitor measurements and clinical outcomes. Results: Among 288 infants randomised (median (IQR) gestational age 26(+2) (25(+3)-27(+1)) weeks), a total number of 51,352 inflations were analysed. The median (IQR) percentage of inflations within the target range in the RFM visible group was 30.0 (18.0-42.2)% vs 30.2 (14.8-43.1)% in the RFM non-visible group (p = 0.721). There were no dierences in other respiratory function measurements, oxygen saturation, heart rate or FiO(2). There were no dierences in clinical outcomes, except for the incidence of intraventricular haemorrhage (all grades) and/or cystic periventricular leukomalacia (visible RFM: 26.7% vs non-visible RFM: 39.0%; RR 0.71 (0.68-0.97); p = 0.028). Conclusion: In very preterm infants receiving PPV at birth, the use of a RFM, compared to no RFM as guidance for tidal volume delivery, did not increase the percentage of inflations in a predefined target range.

【 授权许可】

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