Permissive hypercapnia in extremely low birthweight infants (PHELBI): a randomised controlled multicentre trial

Thomé, Ulrich; Genzel‐Boroviczény, Orsolya; Bohnhorst, Bettina; Schmid, Manuel; Fuchs, Hans; Rohde, Oliver; Avenarius, Stefan; Topf, Hans-Georg; Zimmermann, Andrea; Faas, Dirk; Timme, Katharina; Kleinlein, Barbara; Buxmann, Horst; Schenk, Wilfried; Segerer, Hugo; Teig, Norbert; Gebauer, Corinna; Hentschel, Roland; Heckmann, Matthias; Schlößer, Rolf; Peters, Jochen; Rossi, Rainer; Rascher, Wolfgang; Böttger, Ralf; Seidenberg, J.; Hansen, Gesine; Zernickel, Maria; Alzen, G.; Dreyhaupt, Jens; Muche, Rainer; Hummler, Helmut

doi:10.1016/s2213-2600(15)00204-0

Cited by 94 publications

(100 citation statements)

References 47 publications

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“…More recently post hoc analysis of data from the SUPPORT trial shows an association between higher Pa CO 2 and risk of death, intraventricular haemorrhage, BPD and adverse neurodevelopmental outcome, again highlighting the need for further evaluation of ideal Pa CO 2 targets [95]. The PHELBI trial randomized ventilated preterm babies <29 weeks' gestation and <1,000 g birth weight to two target Pa CO 2 levels for the first 14 days of ventilation, the higher arm reaching about 10 kPa and the lower about 8 kPa [114]. The study was stopped early and analysis performed on 359 of a planned 1,534 infants.…”

Section: Mechanical Ventilation Strategiesmentioning

confidence: 99%

European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update

et al. 2016

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Advances in the management of respiratory distress syndrome (RDS) ensure that clinicians must continue to revise current practice. We report the third update of the European Guidelines for the Management of RDS by a European panel of expert neonatologists including input from an expert perinatal obstetrician based on available literature up to the beginning of 2016. Optimizing the outcome for babies with RDS includes consideration of when to use antenatal steroids, and good obstetric practice includes methods of predicting the risk of preterm delivery and also consideration of whether transfer to a perinatal centre is necessary and safe. Methods for optimal delivery room management have become more evidence based, and protocols for lung protection, including initiation of continuous positive airway pressure and titration of oxygen, should be implemented from soon after birth. Surfactant replacement therapy is a crucial part of the management of RDS, and newer protocols for surfactant administration are aimed at avoiding exposure to mechanical ventilation, and there is more evidence of differences among various surfactants in clinical use. Newer methods of maintaining babies on non-invasive respiratory support have been developed and offer potential for greater comfort and less chronic lung disease. As technology for delivering mechanical ventilation improves, the risk of causing lung injury should decrease although minimizing the time spent on mechanical ventilation using caffeine and if necessary postnatal steroids are also important considerations. Protocols for optimizing the general care of infants with RDS are also essential with good temperature control, careful fluid and nutritional management, maintenance of perfusion and judicious use of antibiotics all being important determinants of best outcome.

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Section: Mechanical Ventilation Strategiesmentioning

confidence: 99%

European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update

et al. 2016

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“…In a recently completed clinical multicenter trial, infants were randomly allocated to 2 different PCO 2 target ranges [15]. Although both target ranges were in the hypercapnic range, there were distinct differences between them.…”

Section: Introductionmentioning

confidence: 99%

“…This resulted in a considerable overlap in actual PCO 2 values between the study groups. Although the randomized assignment to a target group did not significantly influence important clinical outcomes, there were trends suggesting that the higher target range could be associated with an increased risk of bronchopulmonary dysplasia (BPD) and necrotizing enterocolitis (NEC) [15], but does not affect neurodevelopment [16]. Effects such as these may be more evident in analyses based on actual PCO 2 values rather than on the prescribed target ranges.…”

Section: Introductionmentioning

confidence: 99%

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Influence of PCO<sub>2</sub> Control on Clinical and Neurodevelopmental Outcomes of Extremely Low Birth Weight Infants

Thomé¹,

Dreyhaupt

Genzel‐Boroviczény

et al. 2018

Neonatology

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Background: Levels or fluctuations in the partial pressure of CO₂ (PCO₂) may affect outcomes for extremely low birth weight infants. Objectives: In an exploratory analysis of a randomized trial, we hypothesized that the PCO₂ values achieved could be related to significant outcomes. Methods: On each treatment day, infants were divided into 4 groups: relative hypocapnia, normocapnia, hypercapnia, or fluctuating PCO₂. Ultimate assignment to a group for the purpose of this analysis was made according to the group in which an infant spent the most days. Statistical analyses were performed with analysis of variance (ANOVA), the Kruskal-Wallis test, the χ² test, and the Fisher exact test as well as by multiple logistic regression. Results: Of the 359 infants, 57 were classified as hypocapnic, 230 as normocapnic, 70 as hypercapnic, and 2 as fluctuating PCO₂. Hypercapnic infants had a higher average product of mean airway pressure and fraction of inspired oxygen (MAP × FiO₂). For this group, mortality was higher, as was the likelihood of having moderate/severe bronchopulmonary dysplasia (BPD), necrotizing enterocolitis (NEC), and poorer neurodevelopment. Multiple logistic regression analyses showed an increased risk for BPD or death associated with birth weight (p < 0.001) and MAP × FiO₂ (p < 0.01). The incidence of adverse neurodevelopment was associated with birth weight (p < 0.001) and intraventricular hemorrhage (IVH; p < 0.01). Conclusions: Birth weight and respiratory morbidity, as measured by MAP × FiO₂, were the most predictive of death or BPD and NEC, whereas poor neurodevelopmental outcome was associated with low birth weight and IVH. Univariate models also identified PCO₂. Thus, hypercapnia seems to reflect greater disease severity, a likely contributor to differences in outcomes.

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“…There is some conflicting evidence on higher PaCO 2 levels and the impact on mortality, severe intraventricular haemorrhage (IVH), BPD, ROP and neurodevelopmental outcome [30,31]. Therefore, the optimal target carbon dioxide levels are not established; based on available data, it should be between 46 in 60 mm Hg (6.1-8 kPa) for ventilated neonates.…”

Section: Treatment With Oxygenmentioning

confidence: 99%

Respiratory Care of the Neonate

Grosek¹,

Fister²

2018

Selected Topics in Neonatal Care

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The respiratory distress is a very common condition both in term and in preterm neonates and the most frequent reason for admission to the neonatal intensive care unit (NICU). The aetiology greatly depends on the maturation of neonate's organs and perinatal events. The clinical picture is sometimes scarce and very nonspecific for the etiologic determination. Treatment of neonatal RD begins first with the application of a mixture of oxygen and air, then with different modes of non-invasive respiratory support methods. Non-invasive respiratory support can be sustained with nasal continuous positive airway pressure, bi-level positive airway pressure and high-flow nasal cannula ventilation. Non-invasive ventilation with high-frequency oscillations through nasal cannula or masks is also possible with some respiratory devices. Non-invasive ventilation is usually combined with the application of natural surfactant and other therapeutic means, like methylxanthine therapy, prevention and closure of patent ductus arteriosus, and control of infection. In the case of non-invasive ventilation failure, different kinds of invasive ventilation methods are available and being practiced in NICUs. The invasive respiratory support can be maintained by controlled or intermittent mandatory ventilation combined with different supportive synchronous positive inspiratory ventilation, offered by modern respirators.

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Permissive hypercapnia in extremely low birthweight infants (PHELBI): a randomised controlled multicentre trial

Cited by 94 publications

References 47 publications

European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update

European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2016 Update

Influence of PCO<sub>2</sub> Control on Clinical and Neurodevelopmental Outcomes of Extremely Low Birth Weight Infants

Respiratory Care of the Neonate

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