Hemodynamic and metabolic effects of a new pediatric dobutamine formulation in hypoxic newborn pigs.

Background: The aim of our study was to measure drug-related changes in hemodynamics and oxygen metabolism in response to different doses of an age-appropriate dobutamine formulation in hypoxic pigs. A secondary aim was to validate superior vena cava flow (SVCF) as a marker of cardiac index (CI) for subsequent clinical trials of this formulation in humans.

Methods: Newborn pigs (n = 18) were exposed to 2-h hypoxia (10-15% oxygen) followed by reoxygenation (21-30% oxygen 4 h).

Cerebral Effect of Intratracheal Aerosolized Surfactant Versus Bolus Therapy in Preterm Lambs.

Objective: Aerosolization has been proposed as a useful alternative to rapid intratracheal instillation for the delivery of exogenous surfactant in neonatal respiratory distress syndrome. However, there is a lack of information regarding the likely safety of this new therapeutic approach for the neonatal brain. We aimed to compare the cerebral effects of aerosolized versus bolus surfactant administration in premature lambs with respiratory distress syndrome.

In vitro surfactant and perfluorocarbon aerosol deposition in a neonatal physical model of the upper conducting airways.

Objective: Aerosol delivery holds potential to release surfactant or perfluorocarbon (PFC) to the lungs of neonates with respiratory distress syndrome with minimal airway manipulation. Nevertheless, lung deposition in neonates tends to be very low due to extremely low lung volumes, narrow airways and high respiratory rates. In the present study, the feasibility of enhancing lung deposition by intracorporeal delivery of aerosols was investigated using a physical model of neonatal conducting airways.

A Delphi process to optimize quality and performance of drug evaluation in neonates.

Background: Neonatal trials remain difficult to conduct for several reasons: in particular the need for study sites to have an existing infrastructure in place, with trained investigators and validated quality procedures to ensure good clinical, laboratory practices and a respect for high ethical standards. The objective of this work was to identify the major criteria considered necessary for selecting neonatal intensive care units that are able to perform drug evaluations competently.

Methodology And Main Findings: This Delphi process was conducted with an international multidisciplinary panel of 25 experts from 13 countries, selected to be part of two committees (a scientific committee and an expert committee), in order to validate criteria required to perform drug evaluation in neonates.

Dobutamine in paediatric population: a systematic review in juvenile animal models.

Objective: Although dobutamine is widely used in neonatal clinical practice, the evidence for its use in this specific population is not clear. We conducted a systematic review of the use of dobutamine in juvenile animals to determine whether the evidence from juvenile animal experiments with dobutamine supported the design of clinical trials in neonatal/paediatric population.

Methods: Studies were identified by searching MEDLINE (1946-2012) and EMBASE (1974-2012).

Evaluation of fentanyl disposition and effects in newborn piglets as an experimental model for human neonates.

Background: Fentanyl is widely used off-label in NICU. Our aim was to investigate its cerebral, cardiovascular and pulmonary effects as well as pharmacokinetics in an experimental model for neonates.

Methods: Fentanyl (5 µg/kg bolus immediately followed by a 90 minute infusion of 3 µg/kg/h) was administered to six mechanically ventilated newborn piglets.

The role of coagulase-negative staphylococci in early onset sepsis in a large European cohort of very low birth weight infants.

Background: Early Onset Sepsis (EOS) is associated with increased major morbidity and mortality rates among very low birth weight (VLBW) infants. The epidemiology is changing in response to evolving medical practice. The objective of the study was to evaluate EOS epidemiology, risk factors, mortality and major morbidity rates among VLBW infants within a European cohort.

Effect of surfactant and partial liquid ventilation treatment on gas exchange and lung mechanics in immature lambs: influence of gestational age.

Objectives: Surfactant (SF) and partial liquid ventilation (PLV) improve gas exchange and lung mechanics in neonatal RDS. However, variations in the effects of SF and PLV with degree of lung immaturity have not been thoroughly explored.

Setting: Experimental Neonatal Respiratory Physiology Research Unit, Cruces University Hospital.

Acute and sustained effects of aerosolized vs. bolus surfactant therapy in premature lambs with respiratory distress syndrome.

Background: Surfactant (SF) instillation may produce acute deleterious effects on gas exchange and both systemic and cerebral hemodynamics. Our aim was to compare the effects of aerosolized SF (SF-aero) with those of bolus SF (SF-bolus) administration on gas exchange, lung mechanics, and cardiovascular function in premature lambs with respiratory distress syndrome (RDS).

Methods: Fourteen preterm lambs (85% gestation) were randomly assigned to receive SF-aero or SF-bolus.

[Intravenous drug preparation errors in a Neonatal Intensive Care Unit. A potential source of adverse events].

Introduction: To determine the rate of errors during preparation of intravenous drugs in a regional Neonatal Intensive Care Unit (NICU).

Methods: A prospective observational study was performed on 24 non-consecutive working days. The vancomycin and tobramycin solutions administered were analysed to determine drug concentrations.

Aerosolized perfluorocarbon improves gas exchange and pulmonary mechanics in preterm lambs with severe respiratory distress syndrome.

Background: Aerosolized perfluorocarbon (PFC) has been proposed as an alternative method of PFC administration; however, the efficacy of aerosolized PFC in a preterm animal model has not yet been demonstrated.

Methods: Twelve preterm lambs were randomized to two groups: a perfluorodecalin (PFD) aerosol group (n = 6) receiving 10 ml/kg/h of PFD delivered by an intratracheal inhalation catheter followed by 4 h of mechanical ventilation (MV) or the control group, in which animals (n = 6) were managed for 6 h with MV. Gas exchange, pulmonary mechanics, cardiovascular parameters, and cerebral blood flow (CBF) were measured.

[Mortality and morbidity in very low birth weight infants in the Basque Country and Navarra (2001-2006): population-based study].

Introduction: This study describes very low birth weight (VLBW) infant morbidity and mortality in Basque Country and Navarra neonatal units between the years 2001-2006, and evaluates the factors that affect the mortality.

Patients And Methods: A descriptive observational study of a cohort of 1,318 VLBW infants in neonatal units in five Basque Country and Navarra hospitals between 2001 and 2006. A total of 37 variables included in EuroNeoNet database were collected as regards, perinatal risk and protective factors, demographic characteristics, length of stay, interventions, morbidity and mortality.

Comparative effects of bronchoalveolar lavage with saline, surfactant, or perfluorocarbon in experimental meconium aspiration syndrome.

Objective: Today, in meconium aspiration syndrome, treatment focuses on bronchoalveolar lavage, because it removes meconium and proinflammatory factors from airways. This technique might be more effective if different solutions were used such as saline solution, a protein-free surfactant, or a perfluorocarbon, because these would be less inhibited by meconium proteins.

Setting: Pulmonary physiology research unit, Cruces Hospital.

Surfactant and perfluorocarbon aerosolization during different mechanical ventilation strategies by means of inhalation catheters: an in vitro study.

Background: Aerosol delivery of surfactant and perfluorocarbon (PFC) is a desirable therapeutic approach for the treatment of various lung diseases in patients undergoing mechanical ventilation. However, the behavior of these substances during aerosolization differs significantly from that of aqueous solutions. In particular, the high vapor pressure of many PFCs tends to result in greater evaporation during mechanical ventilation.

Early Cerebral Hemodynamic, Metabolic, and Histological Changes in Hypoxic-Ischemic Fetal Lambs during Postnatal Life.

The hemodynamic, metabolic, and biochemical changes produced during the transition from fetal to neonatal life may be aggravated if an episode of asphyxia occurs during fetal life. The aim of the study was to examine regional cerebral blood flow (RCBF), histological changes, and cerebral brain metabolism in preterm lambs, and to analyze the role of oxidative stress in the first hours of postnatal life following severe fetal asphyxia. Eighteen chronically instrumented newborn lambs were randomly assigned to either a control group or the hypoxic-ischemic (HI) group, in which case fetal asphyxia was induced just before delivery.

Pediatric clinical trials in Latin America and Guyana: present views of local practitioners and ways to embrace the future.

Background: Global pediatric research has recently received increased attention by health professionals, and research and government institutions. Since the approval of the FDA Pediatric Exclusivity Provision and the EU Paediatric Regulation, pharmaceutical companies have begun to look to developing/transitional countries for international pediatric research collaboration as a way of facilitating the recruitment of patients to clinical trials. Among countries identified as being 'developing/transitional' some were in the North, Central, and South American regions.

Bronchoalveolar lavage versus bolus administration of lucinactant, a synthetic surfactant in meconium aspiration in newborn lambs.

This study was designed to study effects of lung lavage versus the classical bolus instillation with a peptide-based synthetic surfactant (lucinactant) in a model of Meconium Aspiration Syndrome (MAS). Eighteen newborn lambs received meconium and were randomized to: the experimental meconium installation (eMAS) group-lambs with eMAS kept on conventional mechanical ventilation (control); the SF-Bolus group-eMAS receiving a lucinactant bolus (30 mg/ml); or the D-SF-Lavage group-eMAS treated with dilute lucinactant bronchoalveolar lavage (10 mg/ml). Systemic and pulmonary arterial pressures, blood gases, and pulmonary mechanics were recorded for 180 min.

Surfactant and perfluorocarbon aerosolization by means of inhalation catheters for the treatment of respiratory distress syndrome: an in vitro study.

Background: The aerosolization of perfluorocarbons or surfactant has emerged as a feasible alternative to instillation, for the treatment of experimental respiratory distress syndrome. However, the biophysical properties that make these compounds useful in such therapies, significantly affect the performance of nebulizers. Therefore, in vitro studies are required to assess the suitability of new aerosolization technologies for use with these compounds.

Meta-analysis of passive immunoprophylaxis in paediatric patients at risk of severe RSV infection.

Aim: To review respiratory syncytial virus (RSV), passive immunoprophylaxis (PI) trials and meta-analysis (MA).

Methods: A literature review.

Results: Two MA of PI were found.

Educational strategy to reduce medication errors in a neonatal intensive care unit.

Objective: We aimed to evaluate the effect of a comprehensive preventive educational strategy on the number and type of drug errors in the prescription process in a regional neonatal intensive care unit (NICU).

Design: Medication errors during prescription were recorded in a 41 bed, level III regional neonatal unit by a pharmacist. Data were retrieved from handwritten doctor's orders and introduced at bedsite into an e-database.