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Thierry Lacaze-Masmonteil

Publications and source records attributed to Thierry Lacaze-Masmonteil.

11 recordsLinked to original sources
PubMed2006

A systematic review of intentional delivery in women with preterm prelabor rupture of membranes.

OBJECTIVE: To evaluate the effect of intentional delivery versus expectant management in women with preterm prelabor rupture of membranes (PPROM). METHODS: We searched electronic databases and trials registries, contacted experts, and checked reference lists of relevant studies. Studies were included if they were randomized controlled trials comparing intentional delivery versus expectant management after PPROM, the gestational age of participants was between 30 and 36 weeks, and the study reported one of several pre-determined outcomes. RESULTS: Four studies were included in the meta-analysis. No difference was found between intentional delivery and expectant management in neonatal intensive care unit (NICU) length of stay (LOS) (weighted mean difference (WMD) -0.81 day, 95% confidence interval (CI) -1.66, 0.04), respiratory distress syndrome (risk difference (RD) -0.01, 95% CI -0.07, 0.06), and confirmed neonatal sepsis (RD -0.01, 95% CI -0.05, 0.04). One study found a significantly lower incidence of suspected neonatal sepsis among the intentional delivery group (RD -0.31, 95% CI -0.50, -0.12; number needed to treat (NNT) 3, 95% CI 2, 8). Maternal LOS was significantly shorter for the intentional delivery group (WMD -1.39 day, 95% CI -2.03, -0.75). There was a significant difference in the incidence of clinical chorioamnionitis favoring intentional delivery (RD -0.16, 95% CI -0.23, -0.10; NNT 6, 95% CI 5, 11). There was no significant difference in the incidence of other maternal outcomes, including cesarean section (RD 0.05, 95% CI -0.01, 0.11). CONCLUSIONS: Intentional delivery may be favorable to expectant management for some maternal outcomes (chorioamnionitis and LOS). There is insufficient evidence to suggest that either strategy is beneficial or harmful for the baby. Large multicenter trials with primary neonatal outcomes are required to assess whether intentional delivery is associated with less neonatal morbidity.

Cesarean Section↗
PubMed2005

Comparative efficacy of intratracheal adeno-associated virus administration to newborn rats.

Transient local overexpression of genes that promote lung defense or repair may help to protect or promote alveolar development in premature neonates. We showed that the use of adenoviral vectors in neonates was limited by the induction of lung growth disorders. In the present work we compare the efficiency of gene transfer to the neonatal lung by three adeno-associated viral vectors: rAAV1, rAAV2, and rAAV5. Transduction efficiency was first measured in vitro, by infecting A549 immortalized human lung epithelial cells, and primary epithelial and mesenchymal cells isolated from human fetal lung. AAV vectors yielded similar low levels of luciferase gene expression in the different cell types. In vivo transduction efficiency was evaluated in newborn rats, with AAV-LacZ vectors being intratracheally instilled at 3 days of age. Both rAAV5 and rAAV1, but not rAAV2, induced significant lung beta-galactosidase expression, which persisted on day 35. Highest beta- galactosidase levels were measured with rAAV5, but remained far lower than those obtained with adenoviral vectors. A transient increase in alveolar macrophages was observed on day 6, but not on day 8, after rAAV5-LacZ instillation. Morphometric evaluation of lung structures was performed on day 21, and showed no altered lung growth. We conclude that rAAV1 or rAAV5 was more efficient at mediating gene transfer in the neonatal lung than was rAAV2, without adversely affecting lung development. However, in vivo transgene expression was relatively low, and needs to be improved for future therapeutic use of these adeno-associated vectors.

Animals↗
PubMed2005

A multicenter, randomized, controlled trial of lucinactant versus poractant alfa among very premature infants at high risk for respiratory distress syndrome.

BACKGROUND: Available therapeutic surfactants are either animal-derived or non-protein-containing synthetic products. Animal-derived surfactants contain variable amounts of surfactant apoproteins, whereas the older-generation synthetic products contain only phospholipids and lack surfactant proteins (SPs). Both decrease morbidity and mortality rates associated with respiratory distress syndrome (RDS) among preterm infants, compared with placebo. However, excess mortality rates have been observed with non-protein-containing synthetic surfactants, compared with the animal-derived products. Evidence suggests that synthetic surfactants consisting solely of phospholipids can be improved with the addition of peptides that are functional analogs of SPs. Lucinactant is a new synthetic peptide-containing surfactant that contains sinapultide, a novel, 21-amino acid peptide (leucine and lysine repeating units, KL4 peptide) designed to mimic human SP-B. It is completely devoid of animal-derived components. OBJECTIVE: We hypothesized that the outcomes for premature infants treated with lucinactant and poractant alfa would be similar. Therefore, we compared lucinactant (Surfaxin; Discovery Laboratories, Doylestown, PA) with porcine-derived, poractant alfa (Curosurf; Chiesi Farmaceutici, Parma, Italy) in a trial to test for noninferiority. METHODS: A total of 252 infants born between 24 and 28 weeks of completed gestation, with birth weights between 600 and 1250 g, were assigned randomly in a multicenter, multinational, noninferiority, randomized, controlled study to receive either lucinactant (n = 124) or poractant alfa (n = 128) within 30 minutes of life. The primary outcome was the incidence of being alive without bronchopulmonary dysplasia (BPD) through 28 days of age. Key secondary outcomes included death at day 28 and 36 weeks postmenstrual age (PMA), air leaks, neuroimaging abnormalities, and other complications related to either prematurity or RDS. An independent, international, data and safety monitoring committee monitored the trial. RESULTS: The treatment difference between lucinactant and poractant alfa for survival without BPD through 28 days was 4.75% (95% confidence interval [CI]: -7.3% to 16.8%) in favor of lucinactant, with the lower boundary of the 95% CI for the difference, ie, -7.3%, being greater than the prespecified noninferiority margin of -14.5%. At 28 days, 45 of 119 infants given lucinactant were alive without BPD (37.8%; 95% CI: 29.1-46.5%), compared with 41 of 124 given poractant alfa (33.1%; 95% CI: 24.8-41.3%); at 36 weeks PMA, the rates were 64.7% and 66.9%, respectively. The corresponding mortality rate through day 28 for the lucinactant group was lower than that for the poractant alfa group (11.8% [95% CI: 6.0-17.6%] vs 16.1% [95% CI: 9.7-22.6%]), as was the rate at 36 weeks PMA (16% and 18.5%, respectively). There were no differences in major dosing complications. In addition, no significant differences were observed in the incidences of common complications of prematurity, including intraventricular hemorrhage (grades 3 and 4) and cystic periventricular leukomalacia (lucinactant: 14.3%; poractant alfa: 16.9%). CONCLUSIONS: Lucinactant and poractant alfa were similar in terms of efficacy and safety when used for the prevention and treatment of RDS among preterm infants. The ability to enhance the performance of a synthetic surfactant with the addition of a peptide that mimics the action of SP-B, such as sinapultide, brings potential advantages to exogenous surfactant therapy.

Biological Products↗
PubMed2003

Analysis of 40 sporadic or familial neonatal and pediatric cases with severe unexplained respiratory distress: relationship to SFTPB.

We have analyzed surfactant protein B (SP-B) and its encoding gene (SFTPB, MIM 178640) in 40 unrelated pediatric patients with unexplained respiratory distress (URD). There was high consanguinity (eight kindreds) and an underlying autosomal recessive trait could be inferred in most cases, with overall high sex ratio (32/17) suggesting proband's gender to impact on penetrance. The clinical/biological presentations fitted into three major nosologic frameworks. I: SP-B deficiency (nine probands), complete or incomplete, with homozygous/compoundly heterozygous mutations identified (six probands), including one from the population isolate of Réunion Island (496delG). In addition, there was a consanguineous kindred in which incomplete deficiency was unambiguously unlinked to SFTPB. II: pulmonary alveolar proteinosis (PAP, 19 probands), with typical storage of PAS-positive material within the alveoli with foamy macrophages and variable interstitial reaction, which was diagnosed in most patients from Réunion Island. In contrast to previously published findings, mutation and/or segregation analyses excluded SFTPB as a disease locus, although slight metabolic derangement related to SP-B and/or mild SFTPB changes could somehow contribute to disease. III: URD without evidence for SP-B deficiency or PAP (12 probands), equally unlinked to SFTPB, although a single patient had a possibly causal, maternally-derived, heterozygous genetic change (G4521A). The population frequency of five known and four novel SNPs was studied, providing as many potential markers for pulmonary disease related to SFTPB. Overall, URD was found to be heterogeneous, both phenotypically and genetically, even in population isolates where a founder effect might have been expected. When disease loci are identified, patient genotyping will be crucial as a diagnostic aid, for devising proper treatment, and as a basis for genetic counseling.

Amino Acid Sequence↗
PubMed2003

Exogenous surfactant therapy: newer developments.

There are numerous pulmonary conditions in which qualitative or quantitative anomalies of the surfactant system have been demonstrated. In premature newborns with immature lungs, a functional deficit in surfactant is the main physiopathologic mechanism of the neonatal respiratory distress syndrome (RDS). Since the landmark pilot study of Fujiwara, published more than 20 years ago, the efficacy of exogenous surfactant for the treatment of neonatal RDS has been established by numerous controlled studies and meta-analyses. Promising results have also been reported in infants suffering from other lung disorders in which endogenous surfactant function is compromised. Enlightened by a growing insight into both the structure and function of the different surfactant components, a new generation of synthetic surfactants has been developed. Various complementary approaches have confirmed the fundamental role of the two hydrophobic proteins, SP-B and SP-C, in the surfactant system, thus opening the way to the design of analogues, either by chemical synthesis or expression in a prokaryotic system. These peptide-containing synthetic surfactant preparations are presently undergoing clinical trials, and may eventually replace the animal-derived surfactants currently used for the treatment of RDS.

Clinical Trials as Topic↗
PubMed2003

Evaluation of the safety of palivizumab in the second season of exposure in young children at risk for severe respiratory syncytial virus infection.

BACKGROUND: Palivizumab reduces respiratory syncytial virus (RSV) hospitalisations in high-risk infants. Those with severe bronchopulmonary dysplasia may require two seasons of prophylaxis. There is concern that this humanised antibody might cause an adverse immune response in a second season of use. OBJECTIVE: To evaluate and compare the occurrence of anti-palivizumab antibodies and clinical adverse events in subjects receiving monthly palivizumab injections for a first and second season, and to assess frequency and severity of RSV disease in the two groups. DESIGN AND PATIENTS: Subjects aged or=1 : 80). Serum palivizumab concentrations were similar for the two groups. Nine (12.7%) first season and 8 (12.7%) second season subjects experienced one or more serious adverse events; most were respiratory and all were considered to be not or probably not related to palivizumab. No deaths occurred during the study. CONCLUSIONS: Monthly palivizumab injections were not associated with adverse immune responses or adverse events in young children receiving palivizumab for one or two seasons. Children receiving palivizumab for a second season did not experience more severe adverse events than those receiving it for the first time.

Antibodies, Monoclonal↗
PubMed2003

The short-term outcome of a large cohort of very preterm infants treated with poractant alfa (Curosurf) for respiratory distress syndrome. A postmarketing phase IV study.

OBJECTIVES: To determine the effect of a porcine-derived lung surfactant, poractant alfa (Curosurf), on the respiratory outcome of very preterm infants with established neonatal respiratory distress syndrome (RDS), and to identify risk factors for severe bronchopulmonary dysplasia (BPD) in this population. DESIGN: A multicenter prospective longitudinal cohort study of 924 very preterm infants with RDS, born between 23 and 32 weeks gestation, and treated with at least one dose of poractant alfa during the first 48 hours of life. RESULTS: The median gestational age and the mean birthweight were 29 weeks and 1210 g, respectively; babies born at <28 weeks accounted for 27.1% of the cohort. Infants were treated with poractant alfa 7.9 hours after birth on average. Approximatively 32% of them required at least one additional dose. The mortality rate was 23.5%. The rates of survival without BPD at 28 days postnatal age and 36 weeks postmenstrual age were 38.9% and 54.0%, respectively. In the univariate analysis, factors associated with a higher risk of BPD at 36 weeks postmenstrual age (severe BPD) were low gestational age, low birthweight, poor response to the first dose, and the presence of pneumothorax, interstitial emphysema, pulmonary hemorrhage, patent ductus arteriosus requiring treatment, acquired pulmonary infection, or necrotizing enterocolitis. In the multivariate analysis, significant risk factors for severe BPD were low gestational age, low birthweight, and the presence of interstitial emphysema, pulmonary infection, or necrotizing enterocolitis. CONCLUSION: The rate of RDS-related complications in this high-risk cohort was comparable to the rates observed in the pivotal trials. In very premature infants treated with poractant alfa for established RDS, early barotrauma and postnatal local and/or systemic inflammation are strongly associated with the subsequent development of severe BPD.

Biological Products↗
PubMed2002

Incidence of respiratory syncytial virus-related hospitalizations in high-risk children: follow-up of a national cohort of infants treated with Palivizumab as RSV prophylaxis.

The prophylactic administration of Palivizumab, a monoclonal antibody binding the respiratory syncytial virus (RSV) fusion protein, was recently shown to significantly decrease the incidence of RSV-related hospitalizations among high-risk children (IMpact-RSV trial). While awaiting marketing authorization in France and through a cohort of patients' name-based national program temporarily authorized by the French Drug Agency, a prospective register of all Palivizumab-treated patients in France was set up during the epidemic season 1999-2000. Based on this register, this study was carried out to evaluate the incidence of RSV-related hospitalizations and the safety of prophylaxis among a national cohort of children at high-risk of severe RSV disease. During the study period, guidelines issued by the French Pediatric Society recommended prophylaxis for children either aged less than 6 months at inclusion and born at less than 33 weeks of gestation with a history of bronchopulmonary dysplasia (BPD) at 28 days of life, or aged less than 2 years, born at less than 36 weeks of gestation, and having required treatment for BPD over the previous 6 months. Once included in the program, investigators were to prospectively report the clinical and demographic characteristics of children, all hospitalizations, and reasons for the hospitalizations. Five hundred and sixteen children were treated with 1-5 monthly doses. The median gestational age was 28 weeks, and children born at less than 33 weeks of gestation accounted for 88% of the cohort. The prevalence of BPD was 81%. Ninety children were hospitalized for respiratory illness. In 39 children, hospitalizations were attributed to RSV (7.6% of the total cohort). Among those 39 children, 10 (1.9% of the total cohort) required admission into an intensive care unit, and 4 required mechanical ventilation. No deaths or serious adverse events attributable to RSV infection or Palivizumab treatment were reported. We conclude that the RSV-related hospitalization rate in this high-risk cohort was comparable to the rate observed in the subgroup of Palivizumab-prophylaxed children with BPD in the IMpact-RSV trial.

Antibodies, Monoclonal↗
PubMed2002

Early treatment with erythropoietin beta ameliorates anemia and reduces transfusion requirements in infants with birth weights below 1000 g.

OBJECTIVE: To investigate whether recombinant erythropoietin (rhEPO) reduces the need for transfusion in extremely low birth weight (ELBW) infants (birth weight 500-999 g) and to determine the optimal time for treatment. METHODS: In a blinded multicenter trial, 219 ELBW infants were randomized on day 3 to one of 3 groups: early rhEPO group (rhEPO from the first week for 9 weeks, n = 74), late rhEPO group (rhEPO from the fourth week for 6 weeks, n = 74), or control group (no rhEPO, n = 71). All infants received enteral iron (3-9 mg/kg/day) from the first week. The rhEPO beta dose was 750 IU/kg/week. Success was defined as no transfusion and hematocrit levels never below 30%. RESULTS: Success rate was 13% in the early rhEPO group, 11% in the late rhEPO group, and 4% in the control group (P =.026 for early rhEPO versus control group). Median transfusion volume was 0.4 versus 0.5 versus 0.7 mL/kg/day (P =.02) and median donor exposure was 1.0 versus 1.0 versus 2.0 (P =.05) in the early rhEPO group, the late rhEPO group, and the control group, respectively. Infection risk was not increased and weight gain was not delayed with rhEPO beta. CONCLUSION: Early rhEPO beta treatment effectively reduces the need for transfusion in ELBW infants.

Anemia, Neonatal↗