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Published on: September 6, 2017
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.
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.
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 differences in other respiratory function measurements, oxygen saturation, heart rate or FiO2. There were no differences 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.
Trial Registration:
Dutch Trial Register NTR4104, clinicaltrials.gov NCT03256578.
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