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BACKGROUND: Patent ductus arteriosus is a common complication of prematurity that frequently requires surgical or medical treatment. The benefit of prophylactic treatment by indometacin, a cyclo-oxygenase inhibitor, remains uncertain compared with curative treatment. This benefit could be improved with ibuprofen, another cyclo-oxygenase inhibitor with fewer adverse effects than indometacin on renal, mesenteric, and cerebral perfusion. We aimed to compare prophylactic and curative ibuprofen in the treatment of this abnormality in very premature infants. METHODS: We did a randomised controlled trial in infants younger than 28 weeks of gestation, who were randomly assigned to receive either three doses of ibuprofen or placebo within 6 h of birth. After day 3, symptomatic patent ductus arteriosus was treated first by open curative ibuprofen, then back-up indometacin, surgery, or both. The primary endpoint was need for surgical ligation. Analysis was per protocol. FINDINGS: The study was stopped prematurely after 135 enrollments because of three cases of severe pulmonary hypertension in the prophylactic group. 65 infants received prophylactic ibuprofen, and 66 received placebo. Prophylaxis reduced the need for surgical ligation from six (9%) to zero (p=0.03), and decreased the rate of severe intraventricular haemorrhage from 15 (23%) to seven (11%) (p=0.10). However, survival was not improved (47 [71%] placebo vs 47 [72%] treatment, p=1.00), because of high frequency of adverse respiratory, renal, and digestive events. INTERPRETATION: In premature infants, prophylactic ibuprofen reduces the need for surgical ligation of patent ductus arteriosus, but does not reduce mortality or morbidity. Therefore, it should not be preferred to early curative ibuprofen.

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Two protocols are used by French neonatologists for the treatment of suspected maternofetal infection (SMFI). Three groups of premature and term neonates were included to study the impact of antibiotics on fecal flora: 10 infants with SMFI treated with amoxicillin and netilmicin (group BI), 10 infants with SMFI treated with amoxicillin, cefotoxime and netilmicin (group TRI) and 10 infants without antibiotic therapy as controls (group C). Group BI samples were colonized with Klebsiella oxytoca and Escherichia coli resistant to amoxicillin and by Eneterococcus faecium and coagulase-negative staphylococci. In group TRI biodiversity of the intestinal flora was low, with rapid growth of staphyloccoci and occurrence of Candida spp. These modifications of the intestinal flora should encourage us to use antibiotic treatment as targeted as possible.

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High-frequency oscillation (HFO) is a technique frequently used in neonatal resuscitation, but which has yet to be evaluated. The use of intrathoracic pressures may have an effect on the cerebral circulation of immature neonates. The aim of this study was to examine the variations in cerebral blood velocity and oxygenation during brief pulmonary inflations (sighs), by focusing on alveolar recruitment. In this prospective study performed in 13 intubated and ventilated neonates (alpha = 5%; 1-beta = 80%), mean blood velocity and Doppler Resistance Index were measured, and variations in chromophores concentrations were evaluated by near infrared spectroscopy. Brief inflations at 4 cm H2O above the mean regulated intra-thoracic pressure did not cause any variation in the parameters measured. An explanation for this discordance with animal studies may be the level of pressure chosen, which could be more appropriate for the pulmonary compliance of neonates.

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The aim of this study was to assess the impact of medical and surgical advances on the results of surgery of coarctation of the aorta without major associated cardiac malformations in children aged under 6 months, operated by the surgical team of Tours over a period of 17 years. A retrospective analysis of patients' files allowed inclusion of 75 children: 34 in group I (1980-1988) and 41 in group II (1989-1996). The age at diagnosis, mode of presentation, clinical and echocardiographic parameters, initially and at surgery, were comparable in the two groups. In group II, the surgical procedure of choice changed to the Crafoord procedure (p = 0.0001), the peroperative haemodynamic complications were less common (p = 0.04), patients were operated sooner after diagnosis (p = 0.002) with a higher number of neonates (p = 0.04). There were two early deaths in group I and two late deaths in group II. Six children (8.2%) had recurrence of coarctation. This was more common in children operated before 1 month of age (p = 0.0001) and in cases of hypoplasia of the aortic arch (p < 0.01). The risk of recoarctation in neonates was lower in group II than in group I (p < 0.02). At medium term, the coarctation was considered well repaired in 93.7% and 92.6% of patients in group I and II respectively. However, hypertension on exercise was observed in 8 of the 19 children studied. Finally, secondary surgical or instrumental procedures were required in 9 children to treat associated cardiovascular abnormalities. The authors conclude that in recent years, aortic coarctation was repaired earlier, mainly by a modified Crafoord procedure, with fewer haemodynamic complications, without early mortality. The risk of recoarctation remains low but persistent in neonates. At medium term, hypertension on exercise is a common problem even in children with excellent repairs.

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The fulminant forms of congenital myotonic dystrophy, which rapidly lead to death, are difficult to diagnose. The case described illustrates the roles of persistent pulmonary hypertension in such a fatal form.

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The aim of the study was to assess the short and medium term results of total cavo-pulmonary connection based on analysis of the functional status, the cavo-pulmonary circulation and the surgical techniques, and the hepatic consequences. Fifteen patients with congenital defects beyond repair were treated by total cavo-pulmonary connection at Tours between March 1st 1992 and July 30th 1996. There were 12 children (mean age: 6.3 years) and 3 adults aged 25 to 28. Results were assessed by clinical examination, hepatic function tests and cardiovascular investigations including right heart catheterisation with angiography in 14 patients. There were no fatalities. Seven patients were in functional Class I and 8 in Class II at medium term (average follow-up of 33 months). Hepatic function was mildly abnormal in all patients with an increase in serum bilirubin and gamma GT, and a decrease in the coagulation factors. The mean pressures in the atrial channel were 12 mmHg (9-16 mmHg), in the superior vena 13.2 mmHg (10-18 mmHg), in the right pulmonary artery 9.5 mmHg (7-15 mmHg) and 11.6 mmHg (8-16 mmHg) in the left pulmonary artery. Significant residual stenosis of a pulmonary branch was observed in 2 cases. The cavo-pulmonary anastomoses were out of line, one from the other, in all cases. The atrial channel was tubular in 9 cases and dilated with slight stagnation of the contrast medium in its inferior region in 5 cases. Total cavo-pulmonary connection transformed the clinical status of these patients but was associated with minor abnormalities of liver function. The quality of the cavo-pulmonary circulation and the surgical anastomoses was estimated to be satisfactory in the majority of cases.

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The aim of this study was to assess the results of pulmonary artery banding in a retrospective study of 51 consecutive children treated from January 1980 to December 1993. The study population was 24 girls and 27 boys with an average age of 6.2 months, of average weight of 4.01 kg. The cardiac conditions treated were ventricular septal defects in 24 cases (isolated and associated with one or more cardiovascular malformations or multiple), complete atrioventricular canal in 12 cases (isolated or associated with several cardiovascular malformations), single ventricle in 7 cases, double outlet right ventricle in 3 cases, transposition of the great arteries with ventricular septal defect in 2 cases, tricuspid atresia in 2 cases, and a complex lesion with double discordance in one case. The average duration of banding was 2.35 years (n = 49). Hospital morality of banding was 1.9% (1/51). Late mortality was 14.8% (7/47). Twenty-one patients (42.8%) had complications of banding. The survival rates of children who underwent banding was 86.8% at 1 year and 80.6% at 11 years. The low hospital mortality leaves a role for pulmonary artery banding as a palliative procedure in congenital heart disease in which early correction is impossible or carries and unacceptable risk. Complications of banding justify attempts to improve the technique, by making adjustable bands.

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We report three cases of transient myocardial hypertrophy, diagnosed by echocardiography, occurring between the second and seventh days of life in neonates with initially normal ventricular myocardial wall thickness. The three term neonates had perinatal injury with acute fetal distress. In all three cases electrocardiographic and biologic signs of myocardial ischemia were present. The first echocardiographic results showed abnormalities in systolic or diastolic left ventricular function, without hypertrophy of the walls. The hypertrophic cardiomyopathy (HCM) occurred between days 2 and 7 and affected first the interventricular septum and the free wall of the right ventricle. The left ventricular posterior wall subsequently became abnormal, resulting in severe overall myocardial hypertrophy, which finally disappeared in all three cases between 1 and 5 months of life. Such observations of early severe and transient HCM have not been previously reported. We believe it is a consequence of myocardial ischemia due to acute fetal distress. The prognosis of this type of HCM is good, in contrast to that of other primitive HCM occurring in neonates.

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Systemic pulmonary shunts were performed in 41 consecutive neonates with congenital cyanotic heart disease between 1981 and 1992. The lesions comprised pulmonary atresia with intact interventricular septum (16 cases), pulmonary atresia with ventricular septal defect (9 cases), tetralogy of Fallot (5 cases), transposition of the great arteries (3 cases) and different complex cardiac lesions (8 cases). A polytetrafluoroethylene tube was used in 40 neonates, 5 mm in diameter in 39 cases, anastomosed to be subclavian artery in 21 patients (group A) and on the ascending aorta or innominate artery in 19 patients (group B). A retrospective analysis of the results was undertaken in all patients with a mean follow-up period of 6.5 years (range: 19 months-12.5 years). There were 4 early deaths (9.7%) and 8 late deaths (19.5%) giving a total mortality of 29.2%. Of the late deaths, 4 occurred in the first year, 3 suddenly at home and 4 in relation with the surgical correction. Occlusion of the shunt was suspected in only one case. The actuarial survival rate was 78% at one year, 75.5% at 7 years and 66% at 10 years. Eleven of the 12 deaths were in children with pulmonary atresia with intact interventricular septum (8 cases) and complex cardiac malformations (3 cases). Early complications were observed in 15 of the 37 survivors of the initial procedure. Cardiac failure occurred in 83% of group B and 22% of group A (p < 0.01). The probability of shunt efficacy was 89% at 1 year, 63% at 2 years and 45% at 3 years.(ABSTRACT TRUNCATED AT 250 WORDS)

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Twenty-five infants with suspected or confirmed coagulase negative staphylococcal infection were studied. Continuous administration of vancomycin was used because it is usual with infusions prepared daily for catheterized patients, and because continuous infusions are well tolerated and achieve better penetration in tissues and CSF. Vancomycin acts as a time-dependent antibiotic. The aim was to obtain a level of 20-25 mg/l. in serum. Fifteen newborns term 27-35 weeks (m = 30.3) aged 7-30 days (m = 16.1) received 10 to 45 mg/kg/day of vancomycin and were monitored for 2 to 12 days. The sample for assay was taken in a peripheral vein, and the results were the same during the infusion or 15 minutes after its end. The daily dose of vancomycin necessary varied from 25 to 40 mg/kg for newborns with serum creatinine < 70 mmol/l and 10 to 30 mg/kg with serum creatinine > or = 90 mmol/l. Except for a newborn with multiorgan failure, serum creatinine rapidly decreased. Four newborns term 38-40 weeks (m = 39.5) aged 2-12 days (m = 8.3) received 20 to 45 mg/kg/day of vancomycin and were monitored for 2 to 12 days. The daily dose necessary varied from 30 to 40 mg/kg/day with important individual variations, and 20 mg/kg/day in a newborn with a high level of creatinine. In 6 infants aged 2-22 months receiving 22-45 mg/kg/day of vancomycin, a mean daily dosage of 40-45 mg/kg was adequate, with important individual variations.(ABSTRACT TRUNCATED AT 250 WORDS)

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The birth and subsequent hospitalization of very low birth weight premature infants can be a psychological shock for parents which may disturb further relationships between infant and parents. The parents' memories from the birth period of 94 very low birthweight premature infants (< 32 weeks of gestational age) have been analyzed by way of an interview. This study has shown the painful aspect of the birth and of the parents' first meeting with the infant. However, despite these first difficulties, the relationship normally improves with time.

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In order to estimate the efficacity of prostaglandine E1 (PGE1) to dilate the obstruction in coarctation of the aorta (CoAo), we studied 16 full term neonates with heart failure. Over the 16 neonates, there was 5 with isolated CoAo and 11 with an intracardiac shunt. Over the 11 neonates, 7 had pulmonary hypertension. PGE1, at a dose of 0.05 microgram/kg/min associated to the classical treatment of heart failure were given on the 6 day of life. Effects of PGE1 were evaluated on clinical basis (presence of femoral pulse, blood pressure), echocardiographical basis (ductus arteriosus and aortic isthmus diameter) and morphological basis. In 15 neonates, the ductus arteriosus was open, in all cases CoAo diameter was the same. In 7 neonates with pulmonary hypertension, femoral pulse appeared. In conclusion, PGE1 increases post ductal perfusion by a right to left shunt through the ductus arteriosus, only in cases where pulmonary hypertension is present. No direct action on the aortic isthmus was observed.

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The effect of phenobarbital on cerebral blood flow velocity (CBFV) was studied in 12 clinically stable preterm neonates to evaluate possible mechanisms underlying its protective effect on intracranial hemorrhage. Phenobarbital at loading doses of 20 mg/kg, or placebo (saline) were given intravenously. The study was a cross-over study, each infant successively received placebo, then phenobarbital. Simultaneous recording of heart rate, mean arterial blood pressure (MABP), blood gases were made before, at the end of the injection, and at 15, 30, 60, 90 and 120 min after the end of each administration of either placebo or phenobarbital. Compared with placebo, phenobarbital injection was not associated with significant changes in CBFV and MABP. Heart rate, blood gases did not change significantly. Our data suggest that the protective effect of phenobarbital may minimally be mediated by a direct effect on cerebral blood flow.

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The hospitalisation of low birth weight neonates has an effect on the parent-child relationship. A prospective study on the effects of returning home and on home conditions was conducted in the neonatal unit over a 6-month period. Fifty infants were included in the study. The results showed that difficulties in the parent-child relationship took place after the infant returned home in 11 cases (22%). Examination of the possible role of factors prior to or during the hospital stay indicated the significance of the following: premature delivery, disturbances during the childhood one of the parent's, and the infant's stay in neonatal intensive care unit.

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