Pediatrics
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Randomized Controlled Trial Comparative Study Clinical Trial
A randomized comparison of home and clinic follow-up visits after early postpartum hospital discharge.
Recently enacted federal legislation mandates insurance coverage of at least 48 hours of postpartum hospitalization, but most mothers and newborns in the United States will continue to go home before the third postpartum day. National guidelines recommend a follow-up visit on the third or fourth postpartum day, but scant evidence exists about whether home or clinic visits are more effective. ⋯ For low-risk mothers and newborns in this integrated health maintenance organization, home visits compared with pediatric clinic visits on the third or fourth postpartum hospital day were more costly, but were associated with equivalent clinical outcomes and markedly higher maternal satisfaction. This study had limited power to identify group differences in rehospitalization, and may not be generalizable to higher-risk populations without comparable access to integrated hospital and outpatient care.
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Randomized Controlled Trial Multicenter Study Clinical Trial
A randomized, double-blind, placebo-controlled trial of the effects of prophylactic theophylline on renal function in term neonates with perinatal asphyxia.
The kidney is the most damaged organ in asphyxiated full-term infants. Experiments in rabbits and rats have shown that renal adenosine acts as a vasoconstrictive metabolite in the kidney after hypoxemia and/or ischemia, contributing to the fall in glomerular filtration rate (GFR) and filtration fraction. Vasoconstriction produced by adenosine can be inhibited by the nonspecific adenosine receptor antagonist, theophylline. Gouyon and Guignard performed studies in newborn and adult rabbits subjected to normocapnic hypoxemia. Their results clearly showed that the hypoxemia-induced drop in GFR could be avoided by the administration of low doses of theophylline. ⋯ Our data suggest that prophylactic theophylline, given early after birth, has beneficial effects on reducing the renal dysfunction in asphyxiated full-term infants. (ABSTRACT TRUNCATED)
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Randomized Controlled Trial Multicenter Study Clinical Trial
Effect of infection control measures on the frequency of upper respiratory infection in child care: a randomized, controlled trial.
Acute upper respiratory infections are common in children who attend child care, and preventing transmission of disease in this setting depends on actions by child care staff. We set out to discover whether transmission of respiratory infections in child care could be reduced by improved infection control procedures. ⋯ This trial supports the role of direct transmission of colds in young children in child care. The ability of infection control techniques to reduce episodes of colds in children in child care was limited to children 24 months of age and under.
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Randomized Controlled Trial Clinical Trial Controlled Clinical Trial
Assessing the impact of pediatric-based development services on infants, families, and clinicians: challenges to evaluating the Health Steps Program.
Begun in 1996, the Healthy Steps for Young Children Program (HS) is a new model of pediatric practice that incorporates child development specialists and enhanced developmental services for families of young children. HS is for all families, not just those at high-risk. It is expected to strengthen parents' knowledge, attitudes, and behaviors in ways that promote child health and development, and in turn, to lead to improved child outcomes, such as improved language development, increased utilization of well child care, and decreased problem behaviors, hospitalizations, and injuries. The HS evaluation is designed to assess whether HS is successful in achieving the desired outcomes, measure the program's costs, and determine the relation of the program's costs to its outcomes. ⋯ Throughout a 26-month period, 5565 children enrolled in the evaluation, 2963 (53.2%) children in the intervention group and 2602 (46.8%) in the comparison group. More than 10% of mothers in the Healthy Steps sample are teenagers; 18% have 11 years of education or less; 27% have completed college; 18% are black or African-American; slightly >20% are of Hispanic origin; 36% are single; and close to one-third used Medicaid for their prenatal care. Approximately 7% of infants were low birth weight. When compared with national birth data for the United States as a whole, the Healthy Steps sample seems similarly diverse. However, with the exception of maternal age, the distribution of variables was significantly different from the distribution for US births. There are no differences between intervention and comparison families at randomization sites on any of
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Randomized Controlled Trial Multicenter Study Clinical Trial
Supplemental Therapeutic Oxygen for Prethreshold Retinopathy Of Prematurity (STOP-ROP), a randomized, controlled trial. I: primary outcomes.
To determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to reduce the probability of progression to threshold ROP and the need for peripheral retinal ablation. ⋯ Use of supplemental oxygen at pulse oximetry saturations of 96% to 99% did not cause additional progression of prethreshold ROP but also did not significantly reduce the number of infants requiring peripheral ablative surgery. A subgroup analysis suggested a benefit of supplemental oxygen among infants who have prethreshold ROP without plus disease, but this finding requires additional study. Supplemental oxygen increased the risk of adverse pulmonary events including pneumonia and/or exacerbations of chronic lung disease and the need for oxygen, diuretics, and hospitalization at 3 months of corrected age. Although the relative risk/benefit of supplemental oxygen for each infant must be individually considered, clinicians need no longer be concerned that supplemental oxygen, as used in this study, will exacerbate active prethreshold ROP.