Oral and intravenous doxapram effectively treated most cases of apnoea in preterm infants, avoiding the need for intubation.
A randomized, double-blind, placebo-controlled trial investigating the efficacy and safety of systemic hydrocortisone treatment initiated 7 to 14 days after birth in ventilatordependent, very preterm infants found no significant difference in the composite primary outcome of death or bronchopulmonary dysplasia at 36 weeks' postmenstrual age. 1 However, a preplanned exploratory analysis found a reduced risk of death at 36 weeks' postmenstrual age in favor of hydrocortisone. We examined the prespecified follow-up of death and neurodevelopmental impairment (NDI) at 2 years' corrected age. Methods |The STOP-BPD study was performed in 16 neonatal intensive care units in the Netherlands and Belgium (enrollment November 15, 2011, to December 23, 2016 final follow-up June 27, 2019). Infants born at a gestational age less than 30 weeks and/or with a birth weight less than 1250 g and ventilator dependent between days 7 and 14 were randomly assigned to a 22-day course of systemic hydrocortisone (cumulative dose, 72.5 mg/kg) or placebo. The human research ethics committees approved the protocol and written parental informed consent was obtained. 1 The key outcome at 2 years' corrected age was a composite of death or NDI, with NDI defined as presence of 1 or more of the following: cognitive and/or motor composite score less than 85 on the Bayley Scales of Infant and Toddler Development Third Edition, Dutch version; cerebral palsy greater than level II in the Gross Motor Function Classification System; or hearing or visual impairment.Crude absolute risk differences (RDs) and odds ratios (ORs) with 95% CIs were calculated for the long-term outcome and its individual components for all infants as randomized. A logistic regression and generalized linear model were used to estimate, respectively, the OR and RD for the composite outcome adjusted for stratification factors (center, gestational age). Potential confounding was examined using multivariable logistic regression models with the preselected risk factors of gestational age and small for gestational age for the composite outcome, supplemented with parental education and multilingual environment for the NDI component, and with respiratory index (product of mean airway pressure and the fraction of inspired oxygen), sex, and multiple birth for the death component.Missing data of the key long-term outcome were not imputed because there was sufficient information to classify this outcome in more than 95% of the participants.
Summary Background Adequate premedication before neonatal endotracheal intubation reduces pain, stress, and adverse physiological responses, diminishes duration and number of attempts at intubation, and prevents traumatic airway injury. Therefore, intubation should not be started until an adequate level of sedation is reached. It is not clear how this should be measured in the clinical situation. Objectives The aim of this study is to provide a systematic review of the usability and validity of scoring systems or other objective parameters to evaluate the level of sedation before intubation in neonates. Secondary aims were to describe parameters that are used to determine the level of sedation and criteria on which the decision to proceed with intubation is based. Methods Literature was searched (January 2017) in the following electronic databases: Embase, Medline, Web of Science, Cochrane Central Registrar of Controlled Trials, Pubmed Publisher, and Google Scholar. Results From 1653 hits, 20 studies were finally included in the systematic review. In 7 studies, intubation was started after a predefined time period; in 1 study, preoxygenation was the criterion to start with intubation; and in 12 studies, intubation was started in case of adequate sedation and/or relaxation. Only 4 studies described the use of 3 different objective scoring system, all in the neonatal intensive care unit, which are not validated. Conclusion No validated scoring systems to assess the level of sedation prior to intubation in newborns are available in the literature. Three objective sedation assessment tools seem promising but need further validation before they can be implemented in research and clinical settings.
ObjectiveObservational studies in preterm infants suggest that systemic hydrocortisone improves pulmonary condition but may also lead to systemic adverse effects. We report the short-term pulmonary and systemic effects of hydrocortisone initiated in the second week.DesignRandomised placebo-controlled trial.SettingDutch and Belgian neonatal intensive care units.PatientsInfants born <30 weeks’ gestation and/or birth weight <1250 g, and ventilator dependent in the second week of life.InterventionInfants were randomly assigned to a 22-day course of systemic hydrocortisone (cumulative dose 72.5 mg/kg; n=182) or placebo (n=190).Main outcome measuresData on extubation, ventilator settings, glucose levels, and blood pressure were recorded daily and analysed during the first 7 days of treatment using linear mixed-effects models.ResultsInfants in the hydrocortisone group (24.3%) failed extubation less often compared with placebo (38.6%, crude risk difference: −14.3% (95% CI: −23.4% to −4.8%)). The estimated difference in daily rate of change between hydrocortisone and placebo was −0.42 cmH2O (95% CI: −0.48 to −0.36) for mean airway pressure, −0.02 (95% CI: −0.02 to −0.01) for fraction of inspired oxygen, −0.37 (95% CI: −0.44 to −0.30) for respiratory index, 0.14 mmol/L (95% CI: 0.08 to 0.21) for blood glucose levels and 0.83 mm Hg (95% CI: 0.58 to 1.09) for mean blood pressure.ConclusionsSystemic hydrocortisone initiated between 7 and 14 days after birth in ventilated preterm infants improves pulmonary condition, thereby facilitating weaning and extubation from invasive ventilation. The effects of hydrocortisone on blood glucose levels and blood pressure were mild and of limited clinical relevance.Trial registration numberNetherlands Trial Register (NTR2768; https://www.trialregister.nl/trial/2640) and European Union Clinical Trials Register (EudraCT, 2010-023777-19).
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