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

Henriëtte A van Zanten1, Kristel L A M Kuypers1, Erik W van Zwet2

  • 1Division of Neonatology, Department of Paediatrics, Leiden University Medical Centre, Leiden, the Netherlands.

Resuscitation
|July 24, 2021
PubMed

Insights

Using a respiratory function monitor (RFM) during positive pressure ventilation (PPV) for extremely preterm infants did not improve the delivery of target tidal volumes. This study found no significant difference in the percentage of inflations within the desired range between groups.

Area of Science:

  • Neonatal Medicine
  • Pediatric Resuscitation
  • Respiratory Physiology

Background:

  • Positive pressure ventilation (PPV) is critical for preterm infants at birth.
  • Optimizing tidal volume delivery during PPV is essential for minimizing lung injury.
  • Respiratory function monitors (RFMs) offer real-time feedback on ventilation parameters.

Purpose of the Study:

  • To evaluate if using a respiratory function monitor (RFM) during PPV in extremely preterm infants increases the percentage of inflations with expiratory tidal volume (Vte) in the target range.
  • To compare the efficacy of PPV with and without RFM guidance in achieving target Vte.
  • To assess the impact of RFM use on other respiratory and clinical outcomes.

Main Methods:

  • An unmasked, randomized clinical trial was conducted in 7 neonatal intensive care units across 6 countries from October 2013 to May 2019.
  • Very preterm infants (24-27 weeks gestation) receiving PPV at birth were randomized to either have an RFM screen visible or not.
  • The primary outcome was the median proportion of inflations during manual PPV within the target Vte range (4-8 mL/kg).

Main Results:

  • A total of 51,352 inflations from 288 infants were analyzed.
  • The median percentage of inflations within the target Vte range was similar between the RFM visible group (30.0%) and the RFM non-visible group (30.2%) (p=0.721).
  • No significant differences were observed in other respiratory measurements or oxygen saturation; however, the incidence of intraventricular hemorrhage and/or cystic periventricular leukomalacia was lower in the RFM visible group (26.7% vs. 39.0%, RR 0.71).

Conclusions:

  • The use of a respiratory function monitor (RFM) as guidance for tidal volume delivery during PPV in very preterm infants did not increase the percentage of inflations within the predefined target range.
  • While RFM use did not improve tidal volume targeting, a potential benefit was observed in reduced rates of severe brain injury.
  • Further research is warranted to explore the specific mechanisms behind the observed reduction in intraventricular hemorrhage/cystic periventricular leukomalacia.
Abstract

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