Pediatrics
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To assess the safety, efficacy, and results of the early treatment of infants with craniosynostosis using minimally invasive endoscopic strip craniectomies and postoperative helmet molding therapy. ⋯ The results indicate that the early treatment of craniosynostosis with minimally invasive endoscopic strip craniectomies is a safe, efficacious, and valuable therapeutic alternative to the current extensive surgical treatment modalities. The significantly less blood loss, need for blood transfusions, and length of stay and decreased costs make this procedure an excellent early option for treating infants who present with craniosynostosis.
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New regulatory initiatives have been designed to ensure that new drugs and biologicals include adequate pediatric labeling for the claimed indications at the time of, or soon after, approval. However, because such labeling may not immediately be available, off-label use (or use that is not included in the approved label) of therapeutic agents is likely to remain common in the practice of pediatrics. ⋯ Practitioners may use their professional judgment to determine these uses. Practitioners should understand that the Food and Drug Administration does not regulate off-label use.
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Efficacy and safety of pimecrolimus cream in the long-term management of atopic dermatitis in children.
Pimecrolimus cream (SDZ ASM 981), a nonsteroid inhibitor of inflammatory cytokines, is effective in atopic dermatitis (AD). We assessed whether early treatment of AD signs/symptoms with pimecrolimus could influence long-term outcome by preventing disease flares. ⋯ Treatment of early AD signs/symptoms with pimecrolimus was effective in preventing progression to flares in more than half the patients, reducing or eliminating the need for topical corticosteroids. The benefits were consistently seen at 6 months across important disease severity subgroups and with respect to the various predefined efficacy endpoints. Furthermore, these benefits were sustained for 12 months, providing evidence that long-term treatment with pimecrolimus leads to better control of AD. Treatment with pimecrolimus was well tolerated and was not associated with clinically relevant adverse events compared with the conventional treatment group. The results reported here offer the prospect of effective long-term management of AD with reduced need for topical corticosteroids.
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Comparative Study
Can child deaths be prevented? The Arizona Child Fatality Review Program experience.
To determine the causes and preventability of child deaths; to assess the accuracy of death certificate information; and to assess the number of child abuse deaths that are misdiagnosed as deaths attributable to natural or accidental causes. ⋯ Arizona's child death rate is above the national average (82.16/100 000), but the ACFRP determined that many of these deaths could have been prevented by using known prevention strategies (eg, child safety restraints, pool fencing). Most child mortality data are based on death certificate information that often is incorrect and cannot be used to assess preventability. Although most states have child fatality review programs that review suspected child abuse deaths, <3% of all preventable deaths in Arizona were attributable to child abuse. If all child deaths in the United States were reviewed from a prevention/needs assessment perspective, targeted and data-driven recommendations for prevention could be developed for each community, and potentially 38% of all child deaths that occur after the first month of life could be prevented. The ACFRP is an excellent example of a statewide system with a public health focus. To assist other states in developing similar programs, national support is needed. The establishment of a public health focused federally funded national program would provide us with the opportunity to standardize data collection among states and better utilize this data at a national level.
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Multicenter Study Comparative Study
Psychological outcomes in long-term survivors of childhood leukemia, Hodgkin's disease, and non-Hodgkin's lymphoma: a report from the Childhood Cancer Survivor Study.
To evaluate and compare psychological outcomes in long-term survivors of pediatric leukemia, Hodgkin's disease, and non-Hodgkin's lymphoma and sibling controls. ⋯ This large, sibling-controlled, multisite study of young adult survivors of childhood leukemia, Hodgkin's disease, and non-Hodgkin's lymphoma found that survivors had significant increased risk for reporting symptoms of depression and somatic distress and that intensive chemotherapy added to this risk. However, being a cancer survivor did not compound the effects of gender and SES variables on the 2 outcomes measured. The ability of SES, gender, and treatment-related variables to predict psychological symptoms in this cohort of childhood survivors and sibling controls calls for future research into varied biological and psychosocial pathways by which cancer influences future psychosocial functioning.