We evaluated the effectiveness of sildenafil in the treatment of neonatal pulmonary hypertension. We performed a double-blind randomized clinical trial in 51 full-term infants with persistent pulmonary hypertension confirmed by Doppler echocardiography. Patients were divided in two groups: 20 infants in group A received placebo when the oxygenation index was >20, and 31 infants in group B received 3 mg/kg of oral sildenafil every 6 hours. Arterial blood gases were taken at 1, 4, 7, 13, 19, and 25 hours after treatment was started. Main outcome measures were oxygenation changes, time on mechanical ventilation, and mortality. Both groups were comparable in general variables as well as in illness severity. We observed better oxygenation parameters after 7 hours of sildenafil treatment, but no significant changes were found in the placebo group. Mortality was higher in the placebo group (40%) than in those infants who received sildenafil (6%; P = 0.004), although no difference was found in time on mechanical ventilation between groups. Our results confirm that sildenafil may be a useful adjuvant therapy for term infants with pulmonary hypertension in centers lacking inhaled nitric oxide and extracorporeal membrane oxygenation.
The objective of this paper is to determine the frequency and outcome of asymmetrical septal hypertrophy (ASH) in large-for-gestational-age infants (LGA) born to diabetic (DM) and nondiabetic mothers (NDM), and to establish the relationship between ASH and maternal diabetes control. A comparative study was design to assess ASH in infants born to DM and NDM. The study was conducted in the Departments of Neonatology and Pediatric Cardiology of the "Hospital de Gineco-Pediatria 48", Instituto Mexicano del Seguro Social from January to December 1997. Eighty-five full-term infants of DM (group A) and 85 LGA infants of NDM (group B) were included. As a control group (group C), we studied 85 healthy, full-term infants. In all cases a Doppler echocardiogram was obtained in the first 48 h after birth, and for the ASH infants, at 2 and 4 months. Chest X ray, electrocardiogram, and laboratory tests were performed as complementary studies. ASH was present in 38.8% of LGA infants of DM and in 7.1% of NDM. The difference was significant (p < 0.01). Interventricular septum (IVS) and IVS/ posterior wall of left ventricle ratio were significantly different between groups A and B with C. There was no correlation between Hb A1 level and the presence of ASH in group A. ASH is a common finding in infants of DM. We could not find a relationship between the degree of metabolic control during pregnancy and the incidence and severity of ASH.
The aim of this paper is to assess the efficacy of albumin and dopamine compared with albumin and dobutamine in treating hypotension in preterm newborn infants (PNI). A randomized, open-label, prospective, cross-over study, was designed on 66 PNI whose weights were between 1,000 to 1,500 g, and persistent hypotension, defined as a mean arterial pressure (MAP) of < 30 mmHg. Infants were randomly allocated to two groups and received a 5% albumin infusion at a dosage of 20 mL/kg, in 30 min. Thereafter, one group received dopamine and the other dobutamine at doses of 5 microg/kg/min. If there was not an increase in MAP values > 30 mmHg, the infusions were increased every 20 min by 2.5 microg/kg/min, up to a maximum of 10 microg/kg/min. Treatment failure was considered when there was no pressure response within 2 hr after the infusion started; then patients were changed to the other catecholamine. Statistical analysis was done with student's t-test, x2, and Fisher's exact probability test. There were no differences between groups in initial features. Overall, MAP was normalized with dopamine in 29 of 33 infants and with dobutamine in 25 of 33 infants (p > 0.05). The initial dosage of 5 microg/kg/min, was adequate in 22 infants treated with dopamine and in 13 treated with dobutamine (p < 0.05). The change from dopamine to dobutamine was successful in three out of four patients, while changing from dobutamine to dopamine was adequate in seven out of eight patients. Dopamine is recognized as the drug of choice to treat hypotension in PNI. Since our results showed only small differences in responses, it is proposed that dobutamine is also as efficacious and useful as dopamine.
We analysed the reference error rate of four paediatric journals. The overall rate was 29.7%. Individual rates were as follows: Acta Paediatr 36%, Arch Dis Child 22%, J Pediatr 29%, Pediatrics 32%; the rate of major errors was 1%, 1%, 2%, and 4%, respectively. (Arch Dis Child 2001;85:497-498)
The purpose of this study was to compare the delayed response to Bacillus Calmette-Guérin (BCG) immunization in preterm infants 31.4 to 34.6 weeks of age with full-terms infants by tuberculin test (tuberculin skin test with purified protein derivative [PPD]). One hundred newborns were studied from November 2000 to April 2002, consecutively allocated by convenience in two groups. Group I (GI) included 50 preterm infants from 30 to 34.2 weeks of age at inclusion and 31.4 to 34.6 weeks of age at vaccination. Group II (GII) included 50 full-term newborns. Sick or malnourished patients and those with severe malformations were not included. Newborns were evaluated at 4, 8, and 12 weeks after BCG application for scar measurement. Sixteen weeks after BCG, the PPD with Tubersol was performed. It was defined as a positive reaction when the scar diameter was of 5 mm or more; the same criterion was used for PPD response. Forty-two patients from each group concluded the study. The percentage of positive scar (GI, 64%; GII, 80%; P = 0.142) and the mean of scar diameter (4.5 and 5 mm, respectively) were not statistically significantly different. The rate of positive PPD in GI (81%) and GII (86%), and the mean of PPD in GI (6.7 mm) and GII (6.8 mm) were not statistically different ( P = 0.74). Complications were not observed. This trial showed similar response to PPD after BCG vaccination in preterm and full-term infants.
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