Neonatal renal replacement therapy: An ethical reflection for a crucial decision.

CONTEXT: Technological advances in fetal and neonatal medicine, recent changes in the French legal framework, and encouraging results of the long-term outcomes in children with neonatal renal failure provide elements for an ethical reflection. METHODS: We led a nationwide enquiry among French pediatric nephrologists, intensivists, and neonatologists, exploring the decision-making process when contemplating starting renal replacement therapy (RRT) or delivering palliative care to neonates or infants with pre-end-stage or end-stage renal disease; and the ethical quandaries at hand in such scenarios. RESULTS: A total of 134 responses with complete national coverage were obtained. Care to be delivered to an infant in pre-end-stage or end-stage renal disease did not achieve consensus. Pediatric nephrologists were more prone to initiate a dialysis/graft program than pediatric intensivists. When chronic kidney disease was associated with comorbidities, especially neurological impairment, physicians, regardless of their subspecialty, were more reluctant to initiate conservative treatment. Many of the doctors surveyed did not give their opinion in these prenatal and/or postnatal situations, considered to be unique and warranting a multidisciplinary reflection. CONCLUSION: Such ethical dilemmas are challenging for parents and physicians. They can only be overcome by taking into account both concrete on the ground realities and general principles and values acknowledged to be a basis for respecting the individual. In this way, it ensures humaneness and humanization of a practice that must meet a variety of challenges, one by one. The answer is not simple; it is always unique to each child and can only be approached by a multidisciplinary, time-consuming, open discussion, which will never totally erase uncertainty.

[Value of gastric fluid to start antibiotics in premature babies suspected of having early neonatal bacterial infection]. / Intérêt du liquide gastrique dans la décision d'antibiothérapie du nouveau-né prématuré suspect d'infection bactérienne précoce.

The objective of this study was to evaluate the value of direct examination and culture of gastric fluid in the treatment of early neonatal bacterial infections (INBP) in pre-term infants. MATERIALS AND METHODS: Observational study conducted over 6 months in a Type III center. All hospitalized premature babies who had routine gastric fluid sampling at birth during the period of the study were included. They were classified into two groups: premature infants with probable or suspected infection and treated as such (Group 1) and premature infants with no infection or only having colonization (Group 2). RESULTS AND DISCUSSION: In total, 255 pre-term infants were included in the study. Group 1 consisted of 127 newborns and group 2 consisted of 128 newborns. The direct gastric fluid examination was positive in 51 newborns in Group 1 and in 46 newborns in group 2. The culture was positive in 25 newborns in group 1 and eight newborns in group 2. Direct examination of gastric fluid of the 255 children studied had low sensitivity (40.1%) and low specificity (64%) of INBP, with 52.6% positive predictive value (PPV) and 51.8% negative predictive value (NPV). The gastric fluid culture was specific (93.7%) of the INBP, sensitivity was low (19.6%), with PPV at 75.7% and NPV at 54%. CONCLUSION: These results undermine the relevance of the direct examination of gastric fluid in the delicate diagnosis of INBP. This direct examination has a low PPV and NPV. It is advisable not to start or stop antibiotic therapy solely on this argument; however, it can guide the choice of antibiotic therapy and remains useful for this reason. The culture of gastric fluid has very good specificity (93.7%).

[Diagnosis and management of chronic kidney disease in children: Guidelines of the French Society of Pediatric Nephrology]. / Diagnostic et prise en charge de la maladie rénale chronique de l'enfant : recommandations de la Société de néphrologie pédiatrique (SNP).

These guidelines are intended to assist physicians in the care of children with chronic kidney disease (CKD), defined in children as in adults, regardless of its cause. Often silent for a long time, CKD can evolve to chronic renal failure or end-stage renal disease. Its management aims at slowing disease progression and treating CKD complications as soon as they appear. The different aspects of pediatric CKD care are addressed in these guidelines (screening, treatment, monitoring, diet, quality of life) as proposed by the French Society of Pediatric Nephrology. Highly specialized care provided in the hospital setting by pediatric nephrologists is not detailed.

[Does the regional health care organization impact the outcome of infants born with congenital diaphragmatic hernia?]. / Hernie diaphragmatique congénitale : le devenir des enfants est-il lié aux modalités de prise en charge ?

INTRODUCTION: Congenital diaphragmatic hernia (CDH) is a serious pathology that requires optimal management in very specialized health centers. French medical care organization is regionally based. Hence, evaluating local practices may help deliver clear information to parents before delivery. The aim of this study was to analyze the neonatal characteristics and the postnatal outcome of infants affected with CDH, treated within two different French perinatal health care networks. PATIENTS AND METHODS: Retrospective cohort study of infants with CDH, cared for in the Lorraine perinatal health care network (Réseau Périnatal Lorrain [RPL]) or at Édouard-Herriot Hospital (HEH) in Lyon, between 1997 and 2007. RESULTS: One hundred and twenty-seven newborns were included, 44 in the RPL and 83 in Lyon. Prenatal diagnosis of CDH was similar in RPL and at HEH; 47.7% of infants with CDH died in RPL vs 36.1% in HEH (P=0.2). Surgery delayed for more than 24h was more frequent in RPL (68.6% vs 31.7%; P<0.001), with a postoperative mortality rate of 31.4% vs 15.9%; P=0.08. In RPL, specialized medical follow-up was rare (33.3% vs 100%; P<0.001), while psychomotor retardation was more frequent (33.3% vs 5.7%; P=0.002). CONCLUSION: This study brings to light the diversity of care and outcome for infants affected with CDH in two French perinatal health care networks. These results may help improve both centers' practices. In Lorraine for instance, the follow-up of these vulnerable children can be improved.

Perinatal drug exposure and renal function in very preterm infants.

OBJECTIVE: To determine the impact on glomerular filtration rate (GFR) and tubular function of drugs prescribed to very preterm infants during the first week of life. DESIGN: Prospective multicentre cohort study of infants aged 27-31 weeks gestation. METHODS: GFR was measured on day 2, and then weekly for 1 month, with 12-h urine collection by a standardised kinetic Jaffe method. Infants were classified into two groups according to their GFR on day 7 ('Low GFR' and 'High GFR') with regard to the median reference GFR for their gestational age. Tubular function was also measured weekly for 1 month. Statistical analysis was performed using logistic regression and a repeated measure analysis. RESULTS: Data from 269 infants were analysed, 183 in the 'Low GFR' group and 86 in the 'High GFR' group. Perinatal factors did not differ in both groups. Significantly more infants were treated with ibuprofen in the 'Low GFR' group than in the 'High GFR' group, respectively, n=55 (30.0%) versus n=15 (17.4%), whereas aminoglycosides, glycopeptides and all other drugs commonly prescribed during the first week of life did not show a nephrotoxic effect at usual therapeutic dosage. CONCLUSIONS: Among all drugs described as nephrotoxic in very preterm infants, ibuprofen alone proved to be nephrotoxic in this study for a 1-month span follow-up. If GFR is lower than the median reference value on day 7 after ibuprofen infusion, physicians should keep in mind that glomerular clearance of drugs may stay decreased for the first month of life.

[What blood tests to predict severe hyperbilirubinemia in early maternity discharge?]. / Quel bilan sanguin réaliser avant une sortie précoce de maternité pour prédire un ictère sévère ?

OBJECTIVES: To evaluate the efficiency of blood tests (blood group, direct antiglobulin test) to assess severe hyperbilirubinemia in full-term newborns, delivered from mothers with rhesus negative or O group and to determine clinical and biological factors that may improve the prediction characteristics of this blood test. PATIENTS AND METHODS: We included all the full-term newborns, delivered from mothers with rhesus negative or O group, in a tertiary maternity ward, in 2005, from January6th to December31st. RESULTS: One thousand and ninety-two children were included. Newborns of A, B or AB group delivered from a mother 0 were at increased risk of presenting severe hyperbilirubinemia (OR=2.35 [1.22-4.52]). The negative predictive value was 96%. Yet, the determination of the Coombs test does not increase NPV. CONCLUSION: Systematic performance of blood test for newborns delivered from mother with O group does increase the ability to predict severe hyperbilirubinemia in a newborn infant. Direct antiglobulin test systematic performance remains questionable.

[Neonatal Bartter syndrome's special features in very premature newborns]. / Particularités diagnostiques du syndrome de Bartter néonatal chez le nouveau-né grand prématuré

Neonatal Bartter syndrome is a rare condition, usually revealed by alkalosis and hypokalemia. Clinical and biological signs of neonatal Bartter syndrome are quite different from those encountered when this disease is diagnosed in older children. Diagnosis of neonatal Bartter syndrome is even more difficult in very preterm infants. The aim of this study was to highlight specific clinical and biological signs that may help direct physicians towards the diagnosis of neonatal Bartter syndrome when premature infants present with an atypical renal tubular disorder. Our case reports focus on excessive diuresis with elevated renal sodium excretion and severe dehydration. Correcting tubular disorders early may help avoid dehydration in the fragile preterm newborn.

[Methodological aspects of economic evaluation in pediatrics: illustration by RSV infection prophylaxis in the French setting]. / Aspects méthodologiques de l'évaluation économique du médicament en pédiatrie : exemple de la prophylaxie de l'infection à VRS en France.

The methodological approach of the economic evaluation of drugs in pediatrics is illustrated by the case study of the prophylaxis for RSV infections using palivizumab in the French setting. The indications for the reimbursement of this treatment have been restricted to premature children with bronchopulmonary dysplasia (BPD) or hemodynamically significant congenital-heart disease. A model was developed primarily using the results of the pivotal clinical studies on palivizumab. Unit costs were estimated (2006 values) in both societal and payer's perspectives. An assumption was made and discussed on the benefits of the prophylaxis on mortality. Based on the different data available and the estimated costs and benefits, different cost-effectiveness ratios (CERs) were estimated from both the society's and payer's points of view. A discount rate of 3% was applied to benefit. The CER obtained in the most unfavorable case is considered acceptable for the innovative-medical technologies in the French-healthcare system. Some of the parameters used by the model will be illustrated from the EPIPAGE study data from 2 of the 9 regions involved in this study: this evaluation suggests that the children not having an RSV infection during their 1st year of life will continue to require significantly fewer hospitalizations in the following years. These additional evaluations also suggest that the model overestimates the costs of the treatment with regard to the true medical situation. This could be explained by the model not using the children's exact weight or the real number of injections because the children had been discharged from the maternity ward based on their date of birth and the epidemic period. In spite of these factors, RSV prophylaxis using palivizumab in premature children with BPD or hemodynamically significant congenital-heart disease can be considered cost-effective in France.

[Early discharge of newborns: what problems should we anticipate?]. / Sorties précoces de maternité : quels problèmes anticiper ?

INTRODUCTION: Following Nordic and Anglo-Saxon countries, France is directing towards an early discharge policy from maternity hospitals. French National Authority for Health has published recommendations focusing on the importance to highlight the dangers of such a policy so as to be able to anticipate them. AIM: To describe the complications diagnosed in the newborn infants from day 2 to the current hospital's discharge (noteworthy, if infants are discharged early, these complications may occur at home) to determine predictive factors and to validate those proposed by the French National Authority for Health. METHOD: Prospective study conducted in the maternity ward of Nancy's level III facility, from January 6th to May 6th 2005. RESULTS: Nine hundred and three newborn infants were included. Forty-two (4.6%) presented with complications diagnosed from day 2 to hospital's discharge, among which 4 required urgent neonatal care. The most frequent complication was hyperbilirubinemia: 23 newborns were treated with phototherapy between day 2 and day 10. Statistically significant risk factors of hyperbilirubinemia after day 2 in multivariate analysis were instrumental vaginal delivery (OR=2.94; CI 95% [1.04-8.34]) and jaundice before day 2 (OR=7.39; CI 95% [2.66-20.55]). According to the French National Authority for Health's policy, 33 among 42 infants presenting with a complication would have been withdrawn from an early discharge program. CONCLUSION: In our population, French National Authority for Health's recommendations were relevant to guide an early discharge project.

[Antenatal betamethasone during pregnancy with severe diabetes: is better worse than good?]. / Maturation par bêtaméthasone au cours d'une grossesse de femme présentant un diabète compliqué: le mieux est-il l'ennemi du bien?

Diabetic pregnancy is a precarious situation, both for mother and fetus, because it increases the risk of prematurity and respiratory distress. We report 3 cases of severe acute complications following antenatal betamethasone treatment in mothers presenting with severe diabetes. Corticosteroids are strongly recommended to prevent prematurity complications in newborns. We highlight the high risk profile of theses pregnancies, the effect of this treatment on the mother and the child, and question the real benefit of corticotherapy for these fragile newborns. The metabolic and blood pressure balance is dangerously disturbed in such pregnancies by this treatment. This brings the question of how justified are corticosteroids in such cases?