Authors´ conclusions:administration of inhaled xenon in patients with neonatal hypoxic-ischemic encephalopathy seems to be feasible and safe, but is unlikely to enhance the neuroprotective effect of cooling.
Reviewers´ commentary:the neuroprotective effect on neonatal asphyxia of inhaled xenon associated with hypothermia, observed in experimental animals, has not been confirmed in clinical use. The procedures and application conditions used in this trial have not reflected improvement in surrogate markers of brain damage nor in short term clinical variables.
Ochoa Sangrador C, González de Dios J. Evid Pediatr. 2016;12:4
Authors´ conclusions:autoinflation devices in children with otitis media with effusion is feasible in primary care and effective in clearing effusion and improving symptoms and ear-related child and parent quality of life.
Reviewers´ commentary:autoinflation devices seem to be mildly effective, but the overall benefit would be limited and prior training and consistency is required in their use.
Author’s conclusions: a small body of evidence suggests that frenotomy may be associated with mother-reported improvements in breastfeeding, and potentially in nipple pain, but with small, short-term studies with inconsistent methodology, strength of the evidence is low to insufficient.
Reviewers’ commentary: we will evaluate the damage and benefits of the lingual frenectomy in each particular case until we have more evidence.
Authors’ conclusions: neither paroxetine nor high dose imipramine showed efficacy for major depression in adolescents, and there was an increase in harms with both drugs. Access to primary data from trials has important implications for both clinical practice and research, including that published conclusions about efficacy and safety should not be read as authoritative.
Reviewers’ commentary: the initiative to restore clinical trials by means of primary data reanalysis according to initial protocol has shown false conclusions by deliberate concealment, modification of data and outcomes. The moral, regulatory and medical implications of this problem should reinforce the relevance and utility of secondary research to recognize and amend primary research fraud or misreport.
Jullien S, Cuestas Montañés E. Evid Pediatr. 2016;12:7
Authors´ conclusions:ultrasound is an overused diagnostic test of limited value in the study of cryptorchisdism. Its use delays surgery and increase the overall costs of the process.
Reviewers´ commentary: despite the limitations of the study design, testicular ultrasound in cryptorchidism has limited usefulness as a diagnostic support and could delay surgery with an unfavorable cost-effective value. Therefore, we must question its routine use in the presence of cryptorchidism.
Ortega Páez E, Molina Arias M. Evid Pediatr. 2016;12:8
Authors conclusions:the evidence for the use of glycerin enemas or suppositories in premature infants in inconclusive. Meta-analyzed data suggest that treatment may be associated with increased risk of necrotizing enterocolitis.
Reviewer’s commentary:meta-analysis of the data suggests that the evaluated intervention has no consistent effect on the evacuation of meconium, the transition to full enteral feeding or mortality. There may be an increased risk of NEC, so we can not recommend its use because of the potential risk of harm associated.
Carvajal Encina F, Perdikidis Olivieri L. Evid Pediatr. 2016;12:9
Authors’ conclusions:body temperature is not an accurate marker of serious bacterial infection in febrile children at hospital emergency departments. Younger age and longer duration of illness increase the rule-in potential of temperature but not in a substantial way.
Reviewers’ commentary:body temperature as an isolated marker was not able to discriminate children with serious bacterial infection at a hospital emergency department. In primary care, where pretest probability is lower, results could be even worse. As post-test probability increases with each degree of temperature, it would be interesting to conduct studies to assess if it is worthy to ask for complementary tests in children with fever above certain body temperature.
Authors’ conclusions: among extremely preterm infants, the incidence of bronchopulmonary dysplasia was lower among those who received early inhaled budesonide than among those who received placebo, but the advantage may have been gained at the expense of increased mortality.
Reviewers’ commentary: inhaled budesonide, as a prevention measure of bronchopulmonary dysplasia, show inconsistency in the balance between safety and efficacy. Although it seems that might be effective, it is also associated with a trend to increased mortality, not being known if this occurred by chance or due to some undesirable effects. Therefore, pending further studies, it would seem reasonable not to start prophylactic use systematically, and to restrict it only to the cases of bronchopulmonary dysplasia already established and severe.
Rivas Fernández MÁ, González de Dios J. Evid Pediatr. 2016;12:11
Authors’ conclusions: azithromycin reduces the duration of episodes of asthma-like symptoms (ALS) in young children, suggesting that this drug could have a role in acute management of acute exacerbation.
Reviewers’ comments: the results of this study do not allow us to establish any indication for treatment of ALSs with azithromycin. The very imprecise definition of the concept “ALS” itself, that probably correspond to heterogeneous situations, prevents us to properly identify, in these clinical settings of acute exacerbation of recurrent wheezing, potential specific clinical cases in specific groups of young patients, that could really benefit from the use of azithromycin.
Authors’ conclusions: among children with a history of severe recurrent episodes of wheezing, early administered azithromycin reduces the likelihood of severe recurrent wheezing. More information about the development of resistance due to this strategy is needed.
Reviewers’ commentary: because of its methodological weaknesses, the results of this trial, on the reduction of severe recurrent wheezing after administration of AZT, should be considered with caution and inconclusive. It is to conduct further studies to define precisely which patients would benefit from the use of AZT, for the prevention of recurrent wheezing, minimizing the side effects of it.
Ortega Páez E, Ruiz-Canela Cáceres J. Evid Pediatr. 2016;12:18