Pediatrics
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Randomized Controlled Trial Clinical Trial
Relationship of prolonged pharmacologic serum levels of vitamin E to incidence of sepsis and necrotizing enterocolitis in infants with birth weight 1,500 grams or less.
The incidence of culture-proven neonatal sepsis and necrotizing enterocolitis (NEC) in preterm infants maintained at pharmacologic (mean 5.1 mg/dL +/- 1.45 SD) serum vitamin E levels for long periods was prospectively studied as part of a double-masked clinical trial of the effect of prophylactic vitamin E v placebo treatment on the development and course of retinopathy of prematurity (ROP). Within a few days of birth, 914 preterm infants were enrolled in the study; 545 (275 placebo-treated infants, 270 vitamin E-treated infants had birth weight of 1,500 g or less. A significant difference in incidence of neonatal sepsis (17 placebo-treated infants, 37 vitamin E-treated infants) and NEC (18 placebo-treated infants, 32 vitamin E-treated infants) was observed among infants who had been treated for eight or more days and who had developed neither sepsis nor NEC before that time. ⋯ The data suggest that, if this occurs, it is clinically significant only in the more immature infants. In view of the known variability of absorption of oral vitamin E and the association between high serum vitamin E levels and increased incidence of sepsis and late-onset NEC reported here, it can be concluded that serum vitamin E levels must be monitored when supplemental vitamin E is administered to premature infants, especially those with birth weight 1,500 g or less. The risk-benefit ratio of long-term treatment using vitamin E at high serum levels should be clearly assessed.
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Randomized Controlled Trial Clinical Trial
Ribavirin aerosol treatment of bronchiolitis associated with respiratory syncytial virus infection in infants.
In a double-blind study, bronchiolitis associated with respiratory syncytial virus infection in 12 randomly selected patients treated with ribavirin aerosol improved more rapidly than in 14 control patients given saline aerosol (P = .044, Wilcoxon rank sum test, two-tailed). An estimated 10 mg of ribavirin per kilogram of body weight was administered in daily 12-hour treatments over a five-day period. Respiratory syncytial virus disappeared from secretions at about the same rate in treated and control patients. There was no local or systemic intolerance, and there was no evidence of hematologic or other organ toxicity in the ribavirin-treated patients.
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Randomized Controlled Trial Clinical Trial
Optimal position for a spinal tap in preterm infants.
Inasmuch as spinal taps in preterm infants are frequently accompanied by clinical deterioration, the optimal position for this procedure was investigated. Three positions were each randomly assigned for five minutes to 17 healthy preterm infants without a spinal tap actually being performed: (1) lateral recumbent with full flexion (flexed position), (2) lateral recumbent with partial neck extension (extended position), and (3) sitting with head support and spine flexion (upright position). Transcutaneous PO2 and PCO2 were monitored in all infants, minute ventilation (VI) in seven, and heart rate and blood pressure in ten infants. ⋯ Heart rate increased in each position whereas blood pressure remained unchanged. These data suggest that although hypoventilation may contribute to the observed decrease in transcutaneous PO2, ventilation/perfusion imbalance appears to be the major mechanism. As spinal taps performed in the widely accepted flexed position carry the greatest risk of potential morbidity, it is recommended that this position be modified with neck extension or that spinal taps be performed in the upright position.
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Randomized Controlled Trial Clinical Trial
Failure of hydrocortisone to affect outcome in dengue shock syndrome.
Despite the absence of a clear-cut rationale for their use, corticosteroids are widely employed in the treatment of dengue shock syndrome. Previous comparative therapeutic trials have yielded contradictory results. Resolution of this therapeutic controversy has been attempted with a double-blind evaluation of the clinical effect of steroid administration in dengue shock syndrome. ⋯ The comparison groups were composed of children similar in age, sex, and severity of illness. It is concluded that hydrocortisone is of no value in the treatment of dengue shock syndrome. Reliance should be placed on appropriate supportive and physiologic therapy.
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Randomized Controlled Trial Comparative Study Clinical Trial
Controlled evaluation of muscle relaxation in the ventilated neonate.
To assess the effects of muscle relaxation on the critically ill ventilated neonate, pancuronium bromide was administered for a 12-hour period to ten low-birth-weight neonates (960 to 2,000 gm) of 26 to 34 weeks gestation, all whom required mechanical ventilation and were studied within 48 hours of birth (six to 39 hours). The infants were also studied for a 12-hour period during which no pancuronium bromide was administered. During both study periods, the order of which was randomized, heart rate, blood pressure, PO2, and intracranial pressure were continuously measured. ⋯ Durations of intracranial pressure elevation 10 cm H2O above the infant's baseline were significantly less during paralysis (6.7 vs 58.8 minutes, P less than .001) as were spikes of intracranial pressure to greater than 25 cm H2O (1.6 vs 24.4, P less than .05). There was no significant improvement in blood gas values, fractional inspiratory oxygen, or ventilator settings during muscle relaxation. Pancuronium reduced periods of nonoptimal oxygenation and elevated intracranial pressure and may therefore help to decrease adverse sequelae for the low-birth-weight, ventilated neonate.