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BACKGROUND: The use of early nasal continuous positive airway pressure (ENCPAP) as the mode of initial respiratory support for very low birth weight (VLBW) infants has been increasing. The impact of CPAP and oxygen on gut mucosa and perfusion in premature infants is not known. The relation between ENCPAP and necrotizing enterocolitis (NEC) has not been adequately addressed. OBJECTIVE: To evaluate if the use of an individualized respiratory management strategy encouraging the use of ENCPAP is associated with an increased risk of NEC, and to determine risk factors for NEC in premature infants supported by CPAP. METHODS: A retrospective analysis was conducted on VLBW infants (birth weight < 1500 g) managed at 2 institutions that use an ENCPAP respiratory management strategy for premature infants. Data on the use of oxygen and mode of ventilatory support were collected during the first 3 days of life. Diagnosis of NEC was used as the dependent variable in a logistic regression model. Birth weight, gender, prenatal steroid use, mode of respiratory support (CPAP versus ventilator) and fraction of inspired oxygen, umbilical artery catheter placement, partial pressure of oxygen, patent ductus arteriosus, early sepsis, hospital, and delivery room management (ENCPAP versus initial intubation) were controlled for in the model. RESULTS: Data on 343 premature infants were collected for this study. Mean birth weight was 999 ± 289 g and gestational age was 28 ± 2.6 weeks. The majority of patients were managed with ENCPAP, with only 13% of patients intubated in the delivery room. The overall incidence of NEC was 7% (n = 24). The exposure to ENCPAP did not increase the risk for NEC compared with the use of a ventilator. CONCLUSIONS. The risk of NEC in VLBW premature infants was not increased by the use of ENCPAP. Initial respiratory support with ENCPAP seems to be a safe alternative to routine intubation and mechanical ventilation in premature infants. [ABSTRACT FROM AUTHOR]

OBJECTIVES. To gain a better understanding of the capacity of psychostimulant medications to induce adverse psychiatric reactions and determine the frequency of such reactions, we analyzed postmarketing surveillance data and clinical trial data for drugs, either approved or under development, for the treatment of attention-deficit/hyperactivity disorder. METHODS. The US Food and Drug Administration requested manufacturers of drugs approved for attention-deficit/hyperactivity disorder or with active clinical development programs for that indication to search their electronic clinical trial databases for cases of psychosis or mania using prespecified search terms. The manufacturers supplied descriptions of clinical trials, numbers of patients exposed to study drug, and duration of exposure to permit calculations of incidence rates. Independently, cases of psychosis or mania in children and adults for drugs used to treat attention-deficit/hyperactivity disorder from the Food and Drug Administration Adverse Event Reporting System safety database were analyzed. Manufacturers were asked to conduct similar analyses of their postmarketing surveillance databases. RESULTS. We analyzed data from 49 randomized, controlled clinical trials in the pediatric development programs for these products. A total of 11 psychosis/mania ad- verse events occurred during 743 person-years of double-blind treatment with these drugs, and no comparable adverse events occurred in a total of 420 person-years of placebo exposure in the same trials. The rate per 100 person-years in the pooled active drug group was 1.48. The analysis of spontaneous postmarketing reports yielded >800 reports of adverse events related to psychosis or mania. In ∼90% of the cases, there was no reported history of a similar psychiatric condition. Hallucinations involving visual and/or tactile sensations of insects, snakes, or worms were common in cases in children. CONCLUSIONS. Patients and physicians should be aware that psychosis or mania arising during drug treatment of attention-deficit/hyperactivity disorder may represent adverse drug reactions. [ABSTRACT FROM AUTHOR]