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

Zanten, Henriëtte A. van; Kuypers, Kristel L A M; Zwet, Erik W. van; Vonderen, Jeroen J van; Kamlin, C. Omar F.; Springer, Laila; Lista, Gianluca; Cavigioli, Francesco; Vento, Máximo; Núñez-Ramiro, Antonio; Oberthuer, André; Kribs, Angela; Kuester, Helmut; Horn, Sebastian; Weinberg, Danielle; Foglia, Elizabeth E.; Morley, C J; Davis, Peter G; Pas, Arjan B Te

doi:10.1016/j.resuscitation.2021.07.012

Cited by 45 publications

(63 citation statements)

References 38 publications

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“…In comparison, Zeballos et al reported significantly lower V Te in the RFM visible versus no RFM group with 5.8 (4.7–6.8) and 7 (5.7–9.2) mL/kg (p<0.001), respectively 34. Van Zanten et al reported a non-significant difference in median (IQR) V Te between the RFM group and no RFM group (5.1 (4–7.1) and 5.9 (4.2–8.4) mL/kg, p=0.057) 35…”

Section: Resultsmentioning

confidence: 99%

“…The full text of 36 studies was assessed for eligibility. After review, three RCTs were included in the analysis 33–35. The PRISMA flow diagram is presented in figure 1, study characteristics in table 1 and the GRADE Assessment of Evidence table for key prespecified outcomes shown in table 2.…”

Section: Resultsmentioning

confidence: 99%

“…Bias due to selective reporting was unclear because some secondary outcomes that were stated in the clinical registry were not reported. The study by van Zanten et al 35 had unclear bias for blinding of participants and caregivers; the article stated that the assessors of the waveforms were blinded, but unclear if statistician was blinded.…”

Section: Resultsmentioning

confidence: 99%

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Respiratory function monitoring to improve the outcomes following neonatal resuscitation: a systematic review and meta-analysis

Medeiros

Mangat

Polglase

et al. 2022

Arch Dis Child Fetal Neonatal Ed

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ImportanceAnimal and observational human studies report that delivery of excessive tidal volume (VT) at birth is associated with lung and brain injury. Using a respiratory function monitor (RFM) to guide VT delivery might reduce injury and improve outcomes.ObjectiveTo determine whether use of an RFM in addition to clinical assessment versus clinical assessment alone during mask ventilation in the delivery room reduces in-hospital mortality and morbidity of infants <37 weeks’ gestation.Study selectionRandomised controlled trials (RCTs) comparing RFM in addition to clinical assessment versus clinical assessment alone during mask ventilation in the delivery room of infants born <37 weeks’ gestation.Data analysisRisk of bias was assessed using Covidence Collaboration tool and pooled into a meta-analysis using a random-effects model. The primary outcome was death prior to discharge.Main outcomeDeath before hospital discharge.ResultsThree RCTs enrolling 443 infants were combined in a meta-analysis. The pooled analysis showed no difference in rates of death before discharge with an RFM versus no RFM, relative risk (RR) 95% (CI) 0.98 (0.64 to 1.48). The pooled analysis suggested a significant reduction for brain injury (a combination of intraventricular haemorrhage and periventricular leucomalacia) (RR 0.65 (0.48 to 0.89), p=0.006) and for intraventricular haemorrhage (RR 0.69 (0.50 to 0.96), p=0.03) in infants receiving positive pressure ventilation with an RFM versus no RFM.ConclusionIn infants <37 weeks, an RFM in addition to clinical assessment compared with clinical assessment during mask ventilation resulted in similar in-hospital mortality, significant reduction for any brain injury and intraventricular haemorrhage. Further trials are required to determine whether RFMs should be routinely available for neonatal resuscitation.

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Section: Resultsmentioning

confidence: 99%

Section: Resultsmentioning

confidence: 99%

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Respiratory function monitoring to improve the outcomes following neonatal resuscitation: a systematic review and meta-analysis

Medeiros

Mangat

Polglase

et al. 2022

Arch Dis Child Fetal Neonatal Ed

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“…The neonatologists evaluated this trial individually, as they were asked about their general understanding and experience with this study and obstacles and possible improvements with regard to the PB-CPAP protocol specifically. Physiological outcomes included SpO 2 , FiO 2 , SpO 2 /FiO 2 ratio, heart rate, duration of hypoxia [SpO 2 <25th percentile of Dawson's target ranges (27)] and bradycardia (heart rate <100 bpm) during the first 5 and 10 min after birth. Respiratory effort parameters included breathing rate, inter-breath interval variability, minute volume, inspired tidal volume, peak inspiratory flow rate (PIFR) and the use of iPPV and caffeine.…”

Section: Methodsmentioning

confidence: 99%

“…The sample size calculation is based on infants who were born in the LUMC, participated in DR studies ( 11 , 28 ) and received 5–8 cmH 2 O CPAP. Infants ( n = 78) achieved a mean SpO 2 of 59% ± 13 in the first 5 min after birth.…”

Section: Methodsmentioning

confidence: 99%

Feasibility and Effect of Physiological-Based CPAP in Preterm Infants at Birth

et al. 2021

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Background: Preterm infants are commonly supported with 5–8 cmH2O CPAP. However, animal studies demonstrate that high initial CPAP levels (12–15 cmH2O) which are then reduced (termed physiological based (PB)-CPAP), improve lung aeration without adversely affecting cardiovascular function. We investigated the feasibility of PB-CPAP and the effect in preterm infants at birth.Methods: Preterm infants (24–30 weeks gestation) were randomized to PB-CPAP or 5–8 cmH2O CPAP for the first 10 min after birth. PB-CPAP consisted of 15 cmH2O CPAP that was decreased when infants were stabilized (heart rate ≥100 bpm, SpO2 ≥85%, FiO2 ≤ 0.4, spontaneous breathing) to 8 cmH2O with steps of ~2/3 cmH2O/min. Primary outcomes were feasibility and SpO2 in the first 5 min after birth. Secondary outcomes included physiological and breathing parameters and short-term neonatal outcomes. Planned enrollment was 42 infants.Results: The trial was stopped after enrolling 31 infants due to a low inclusion rate and recent changes in the local resuscitation guideline that conflict with the study protocol. Measurements were available for analysis in 28 infants (PB-CPAP n = 8, 5–8 cmH2O n = 20). Protocol deviations in the PB-CPAP group included one infant receiving 3 inflations with 15 cmH2O PEEP and two infants in which CPAP levels were decreased faster than described in the study protocol. In the 5–8 cmH2O CPAP group, three infants received 4, 10, and 12 cmH2O CPAP. During evaluations, caregivers indicated that the current PB-CPAP protocol was difficult to execute. The SpO2 in the first 5 min after birth was not different [61 (49–70) vs. 64 (47–74), p = 0.973]. However, infants receiving PB-CPAP achieved higher heart rates [121 (111–130) vs. 97 (82–119) bpm, p = 0.016] and duration of mask ventilation was shorter [0:42 (0:34–2:22) vs. 2:58 (1:36–6:03) min, p = 0.020]. Infants in the PB-CPAP group required 6:36 (5:49-11:03) min to stabilize, compared to 9:57 (6:58–15:06) min in the 5–8 cmH2O CPAP group (p = 0.256). There were no differences in short-term outcomes.Conclusion: Stabilization of preterm infants with PB-CPAP is feasible but tailoring CPAP appeared challenging. PB-CPAP did not lead to higher SpO2 but increased heart rate and shortened the duration of mask ventilation, which may reflect faster lung aeration.

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