Validation of the disposable T-piece resuscitator (Neo-Tee): a bench study.

OBJECTIVE: The Neo-Tee Infant T-piece resuscitator is a disposable T-piece resuscitator. The aim of this bench study was to assess the accuracy of the Neo-Tee using a measurement set-up and settings mimicking clinical practice. STUDY DESIGN: Nine Neo-Tee devices were tested using a face mask interface and a manikin. Pressures were set using the built-in manometer and simultaneously measured at the interface. Peak inspiratory pressure (PIP) and positive end-expiratory pressure (PEEP) were studied under static conditions and positive pressure ventilation (PPV), using a wide range of clinically relevant flows and pressures. Pressures were measured without adjusting for a possible offset of PIP and PEEP after switching from static pressures to PPV. In an additional subset of measurements, PIP/PEEP offsets on the Neo-Tee manometer after starting PPV were adjusted. RESULTS: Under static conditions, setting the PEEP level with the Neo-Tee manometer results in overestimation of the true PEEP applied at the airway opening, with a difference of approximately 1.5 cmH2O. When switching to PPV, this difference almost disappears. In contrast to PEEP, PIP levels measured at the airway opening were accurate.Adjusting PIP and PEEP on the built-in manometer after starting PPV was necessary in all measurements, but this did not improve the accuracy of the targeted pressure delivery, especially for PEEP. A gas flow rate of 5 L/min was insufficient to reach commonly used PEEP levels of 5 cmH2O. CONCLUSION: The Neo-Tee T-piece resuscitator is accurate for delivering a static inflation and PPV, but not for delivering continuous positive airway pressure.

Restricted Ventilation Associated with Reduced Neurodevelopmental Impairment in Preterm Infants.

BACKGROUND AND OBJECTIVE: Restrictive use of invasive mechanical ventilation (IMV) in preterm infants reduces the risk of bronchopulmonary dysplasia (BPD). Our objective was to determine its effect on neurodevelopmental impairment (NDI) at 24 months' corrected age (CA). METHODS: This retrospective single-center cohort study included all patients with a gestational age <30 weeks born in 2004/2005 (epoch 1) and 2010/2011 (epoch 2). In epoch 2, we introduced a policy of restriction on IMV and liberalized the use of respiratory stimulants in the delivery room and neonatal intensive care. Data on patient characteristics, respiratory management, short-term outcomes, mortality, BPD, and NDI at 24 months' CA were collected. RESULTS: Four hundred and four preterm infants were included. Compared to those in epoch 1, infants in epoch 2 were less likely to be intubated and the duration of IMV was shorter. Other noninvasive adjuvant therapies such as caffeine, doxapram, and nasal ventilation were more often used during epoch 2. There was a trend to less BPD in epoch 2 compared to epoch 1 (17 vs. 23%, adjusted OR = 0.75, 95% CI: 0.48, 1.16). Mortality did not change over time. The combined outcome death or NDI at 24 months' CA was significantly lower in epoch 2 compared to epoch 1 (24.7 vs. 33.9%, adjusted OR = 0.71, 95% CI: 0.53, 0.97). CONCLUSIONS: Restricted use of IMV is feasible in preterm infants and might be associated with a reduced risk of the combined outcome death or NDI at 24 months' CA. Larger studies are needed to confirm these findings.

Individualized lung recruitment during high-frequency ventilation in preterm infants is not associated with lung hyperinflation and air leaks.

UNLABELLED: Lung recruitment during high-frequency ventilation (HFV) in preterm infants with respiratory distress syndrome (RDS) has been associated with an increased risk of lung hyperinflation and air leaks. Individualizing the lung recruitment procedure to the severity of lung disease of each patient might reduce these risks. In this prospective cohort study, we evaluated chest X-ray (CXR) characteristics during individualized oxygenation-guided lung recruitment with HFV in preterm infants with RDS, before and after surfactant therapy. Two pediatric radiologists scored radiolucency, the presence of lung hyperinflation, and/or air leaks following lung recruitment during HFV in 69 infants before and 39 infants after surfactant treatment. Following lung recruitment, the median radiolucency score was 2, with 44 (64 %) infants having a score ≤2. Only mild to moderate hyperinflation was seen in 13 (19 %) infants, with no air leaks. After the surfactant, the radiolucency score improved in 62 % of 39 paired CXRs (p < 0.001). Mild to moderate hyperinflation was seen in nine (24 %) patients. During the entire admission, only four (6 %) of the patients developed air leaks. CONCLUSION: The risk of significant hyperinflation and air leaks is low when using an individualized oxygenation-guided recruitment procedure during HFV in preterm infants with RDS. WHAT IS KNOWN: • Lung recruitment during high-frequency ventilation in preterm infants with respiratory distress syndrome is associated with an increased risk of lung hyperinflation and air leaks. What is New: • The risk of lung hyperinflation and air leaks is low when using an individualized oxygenation-guided lung recruitment procedure during high-frequency ventilation in preterm infants with respiratory distress syndrome.

Incidence of hypo- and hyper-capnia in a cross-sectional European cohort of ventilated newborn infants.

OBJECTIVE: To determine the incidence of hypo- and hyper-capnia in a European cohort of ventilated newborn infants. DESIGN AND SETTING: Two-point cross-sectional prospective study in 173 European neonatal intensive care units. PATIENTS AND METHODS: Patient characteristics, ventilator settings and measurements, and blood gas analyses were collected for endotracheally ventilated newborn infants on two separate dates. RESULTS: A total of 1569 blood gas analyses were performed in 508 included patients with a mean±SD Pco2 of 48±12 mm Hg or 6.4±1.6 kPa (range 17-104 mm Hg or 2.3-13.9 kPa). Hypocapnia (Pco2<30 mm Hg or 4 kPa) and hypercapnia (Pco2>52 mm Hg or 7 kPa) was present in, respectively, 69 (4%) and 492 (31%) of the blood gases. Hypocapnia was most common in the first 3 days of life (7.3%) and hypercapnia after the first week of life (42.6%). Pco2 was significantly higher in preterm infants (49 mm Hg or 6.5 kPa) than term infants (43 mm Hg or 5.7 kPa) and significantly lower during pressure-limited ventilation (47 mm Hg or 6.3±1.6 kPa) compared with volume-targeted ventilation (51 mm Hg or 6.8±1.7 kPa) and high-frequency ventilation (50 mm Hg or 6.7±1.7 kPa). CONCLUSIONS: This study shows that hypocapnia is a relatively uncommon finding during neonatal ventilation. The higher incidence of hypercapnia may suggest that permissive hypercapnia has found its way into daily clinical practice.

Early prediction of nasal continuous positive airway pressure failure in preterm infants less than 30 weeks gestation.

AIM: To predict early nasal continuous positive airway pressure failure within the first 2 h after birth in preterm infants. METHODS: Patient and respiratory support variables significantly associated with continuous positive airway pressure failure in the first 72 h after birth were identified in a cohort of preterm infants <30 weeks gestation. Using multivariable logistic regression analysis, risk estimates for early nasal continuous positive airway pressure failure were calculated. RESULTS: From 182 infants included, 62(34%) failed early nasal continuous positive airway pressure. Birth weight ≤800 g, male gender and a fraction of inspired oxygen >0.25 at 1 and 2 h of age were significantly associated with early nasal continuous positive airway pressure failure. Combining these variables in a logistic regression model provided a minimal risk estimate for failure of 0.04[0.01-0.23] (female >800 g, FiO(2) ≤ 0.25 at 1, and 2 h) and maximal estimate of 0.92[0.44-0.99] (male ≤800 g, FiO(2) > 0.25 at 1 and 2 h). CONCLUSION: Combining gender, birth weight and the fraction of inspired oxygen at 1 and 2 h of age allows for a better and more individualized prediction of early nasal continuous positive airway pressure failure in preterm infants less than 30 weeks gestation.

Systemic Hydrocortisone To Prevent Bronchopulmonary Dysplasia in preterm infants (the SToP-BPD study); a multicenter randomized placebo controlled trial.

BACKGROUND: Randomized controlled trials have shown that treatment of chronically ventilated preterm infants after the first week of life with dexamethasone reduces the incidence of the combined outcome death or bronchopulmonary dysplasia (BPD). However, there are concerns that dexamethasone may increase the risk of adverse neurodevelopmental outcome. Hydrocortisone has been suggested as an alternative therapy. So far no randomized controlled trial has investigated its efficacy when administered after the first week of life to ventilated preterm infants. METHODS/DESIGN: The SToP-BPD trial is a randomized double blind placebo controlled multicenter study including 400 very low birth weight infants (gestational age < 30 weeks and/or birth weight < 1250 grams), who are ventilator dependent at a postnatal age of 7 - 14 days. Hydrocortisone (cumulative dose 72.5 mg/kg) or placebo is administered during a 22 day tapering schedule. Primary outcome measure is the combined outcome mortality or BPD at 36 weeks postmenstrual age. Secondary outcomes are short term effects on the pulmonary condition, adverse effects during hospitalization, and long-term neurodevelopmental sequelae assessed at 2 years corrected gestational age. Analysis will be on an intention to treat basis. DISCUSSION: This trial will determine the efficacy and safety of postnatal hydrocortisone administration at a moderately early postnatal onset compared to placebo for the reduction of the combined outcome mortality and BPD at 36 weeks postmenstrual age in ventilator dependent preterm infants.

Surfactant replacement therapy in preterm infants: a European survey.

BACKGROUND: Exogenous surfactant is an undisputed treatment for neonatal respiratory distress syndrome but its efficacy is highly dependent on the treatment strategy. International guidelines have published recommendations on the optimal surfactant replacement strategy. OBJECTIVE: To determine how evidence-based guidelines on surfactant replacement therapy are implemented in daily clinical practice. METHODS: Data on surfactant replacement therapy, including preparation, dosing and timing, were collected in 173 European neonatal intensive care units (NICUs) by questionnaire and in a cohort of preterm infants mechanically ventilated on two separate predefined dates in these units. RESULTS: All NICUs used animal-derived surfactant in the treatment of respiratory distress syndrome, with Poractant being most widely used (86%). The most frequently used first dose was 100 mg/kg (58%) and 200 mg/kg (39%) and all NICUs allowed for repeat dosing. 39% of the NICUs claimed to use prophylactic treatment (<15 min of life). Data on surfactant treatment were collected in 338 infants, with a median gestational age of 27 weeks and a birth weight of 860 g. All infants were treated with animal-derived surfactant. The median first dose was 168 mg/kg in the Poractant group compared with 100 mg/kg in the Beractant and Bovactant groups. Prophylactic treatment was used in 23% of the infants and 28% of the infants received surfactant >2 h after birth. 43% of the infants received multiple doses. CONCLUSIONS: With the exception of surfactant timing, guidelines on surfactant replacement therapy seem to be implemented in daily clinical practice in European NICUs.

Open-label glucocorticoids modulate dexamethasone trial results in preterm infants.

CONTEXT: Open-label glucocorticoids (OLGs) were often used in trials that investigated postnatal dexamethasone treatment in ventilated preterm infants. OBJECTIVE: To determine if OLG use modulates the dexamethasone treatment effect on mortality, bronchopulmonary dysplasia (BPD), and neurodevelopmental outcome. METHODS: Electronic databases, abstracts from the Pediatric Academic Societies, and results of manual reference searches were used as data sources. Fifteen randomized controlled trials comparing dexamethasone with placebo in 721 ventilated preterm infants older than 7 days were identified. The interaction between dexamethasone treatment effect and OLG use was assessed by meta-regression analysis and subgroup meta-analysis according to the percentage of OLG use in the placebo group. Trials with a moderately early (7- to 14-day) or delayed (>3-week) treatment onset were analyzed separately. RESULTS: Moderately early, but not delayed, dexamethasone treatment significantly reduced mortality rates in trials with OLG use at <30% in the placebo arm. Meta-regression analysis revealed that this reduction was inversely related to OLG use. Increasing OLG use strengthened the positive effect of dexamethasone on BPD in the moderately early trials but attenuated the effect in the delayed-treatment trials. In trials with <30% OLG use, dexamethasone increased the risk for cerebral palsy in the delayed, but not the moderately early, treatment trials. CONCLUSIONS: When OLG use is taken into account moderately early dexamethasone treatment reduced mortality rates and the combined outcome mortality and BPD without increasing the risk of adverse neurodevelopmental outcome in ventilated preterm infants. A large randomized controlled trial is needed to confirm or refute these findings.

Ventilation practices in the neonatal intensive care unit: a cross-sectional study.

OBJECTIVE: To assess current ventilation practices in newborn infants. STUDY DESIGN: We conducted a 2-point cross-sectional study in 173 European neonatal intensive care units, including 535 infants (mean gestational age 28 weeks and birth weight 1024 g). Patient characteristics, ventilator settings, and measurements were collected bedside from endotracheally ventilated infants. RESULTS: A total of 457 (85%) patients were conventionally ventilated. Time cycled pressure-limited ventilation was used in 59% of these patients, most often combined with synchronized intermittent mandatory ventilation (51%). Newer conventional ventilation modes like volume targeted and pressure support ventilation were used in, respectively, 9% and 7% of the patients. The mean tidal volume, measured in 84% of the conventionally ventilated patients, was 5.7 ± 2.3 ml/kg. The mean positive end-expiratory pressure was 4.5 ± 1.1 cmH(2)O and rarely exceeded 7 cmH(2)O. CONCLUSIONS: Time cycled pressure-limited ventilation is the most commonly used mode in neonatal ventilation. Tidal volumes are usually targeted between 4 to 7 mL/kg and positive end-expiratory pressure between 4 to 6 cmH(2)O. Newer ventilation modes are only used in a minority of patients.

Finding the optimal postnatal dexamethasone regimen for preterm infants at risk of bronchopulmonary dysplasia: a systematic review of placebo-controlled trials.

CONTEXT: Postnatal dexamethasone therapy reduces the incidence of bronchopulmonary dysplasia in preterm infants but may be associated with an increased risk for adverse neurodevelopmental outcome. OBJECTIVE: Our goal was to determine if the effects of dexamethasone on mortality and pulmonary and neurodevelopmental sequelae in preterm infants are modified by the cumulative dose given. METHODS: Randomized, controlled trials comparing dexamethasone with placebo in ventilated preterm infants >7 days old were identified by searching the electronic databases and the abstracts from the Pediatric Academic societies and by performing manual reference searches. Two reviewers independently assessed eligibility and quality of trials and extracted data on study design, patient characteristics, and relevant outcomes. Original trialists were asked to provide additional data. RESULTS: Sixteen trials including 1136 patients were analyzed by using meta-analysis and metaregression. Additional data were provided by 12 original trialists. Trials with a moderately early (7- to 14-day) or delayed (>3-week) postnatal treatment onset were analyzed separately. Higher dexamethasone doses reduced the relative risk for the combined outcome, mortality or bronchopulmonary dysplasia, with the largest effect in trials that used a cumulative dose of >4 mg/kg. No effect was found of doses on the risk of neurodevelopmental sequelae in the delayed treatment studies, but in the moderately-early-treatment studies the risk of mortality or cerebral palsy decreased by 6.2%, and the risk of a Mental Developmental Index below -2 SDs decreased by 6.6% for each incremental mg/kg cumulative dexamethasone dose. CONCLUSIONS: Higher cumulative dexamethasone doses administered after the first week of life may decrease the risk for bronchopulmonary dysplasia without increasing the risk for neurodevelopmental sequelae in ventilated preterm infants. A large randomized trial is needed to confirm or refute these findings.

Effects of higher versus lower dexamethasone doses on pulmonary and neurodevelopmental sequelae in preterm infants at risk for chronic lung disease: a meta-analysis.

OBJECTIVES: Systemic postnatal dexamethasone treatment reduces the risk of chronic lung disease in preterm infants but also may be associated with increased risk of neurodevelopmental impairment. Because it is not known whether these effects are modulated by the cumulative dexamethasone dose, we systematically reviewed the available randomized evidence on the effects of lower versus higher cumulative dexamethasone doses, in terms of death, pulmonary morbidity, and neurodevelopmental outcomes, in preterm infants. METHODS: Randomized, controlled trials comparing higher- versus lower-dosage dexamethasone regimens in ventilated preterm infants were identified by searching the main electronic databases, references from relevant studies, and abstracts from the Societies for Pediatric Research (from 1990 onward). Eligibility and quality of trials were assessed, and data on study design, patient characteristics, and relevant outcomes were extracted. RESULTS: Six studies that enrolled a total of 209 participants were included; 2 studies contrasted cumulative dexamethasone doses in the higher ranges (>2.7 mg/kg in the higher-dosage regimen) and 4 in the lower ranges (