Abstract:
OBJECTIVE: New treatments are needed for multidrug-resistant (MDR) gram-negative infections in neonates. Ceftolozane/tazobactam is a β-lactam/β-lactamase inhibitor combination that has broad-spectrum activity against most common gram-negative bacteria, including MDR strains. We evaluated pharmacokinetics (PK) and safety of ceftolozane/tazobactam in term and premature neonates and young infants. STUDY DESIGN: This is a subgroup analysis of a phase 1, noncomparative, open-label, multicenter study that characterized the PK, safety, and tolerability of a single intravenous (IV) dose of ceftolozane/tazobactam in pediatric patients with proven/suspected gram-negative infection or receiving perioperative prophylaxis. RESULTS: Seven patients were enrolled in Group A (birth [7 days postnatal] to < 3 months, > 32 weeks gestation) and six patients were enrolled in Group B (birth [7 days postnatal] to < 3 months, ≤ 32 weeks gestation). PK profiles in neonates and young infants were generally comparable to those of older children receiving a single IV dose of ceftolozane/tazobactam. No serious adverse events (AEs), treatment-related AEs, severe AEs, or clinically significant laboratory abnormalities were reported. CONCLUSION: Among term and premature neonates and young infants, PK was comparable to older children and ceftolozane/tazobactam was generally well tolerated. An adaptable and flexible study design is necessary for enrollment in neonatal PK trials.
journal_name
Am J Perinatoljournal_title
American journal of perinatologyauthors
Ang JY,Arrieta A,Bradley JS,Zhang Z,Yu B,Rizk ML,Johnson MG,Rhee EGdoi
10.1055/s-0039-3402719subject
Has Abstractpub_date
2020-01-07 00:00:00eissn
0735-1631issn
1098-8785pub_type
杂志文章abstract:OBJECTIVE: Potentially avoidable maternity complications (PAMCs) have been validated as an indicator of access to quality prenatal care. African-American mothers have exhibited a higher incidence of PAMCs, which has been attributed to unequal health coverage. The objective of this study was to assess if racial disparit...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-0040-1701195
更新日期:2020-01-27 00:00:00
abstract::Background Association studies of various gene variants in neonatal sepsis show conflicting results. Objective We performed a systematic review of candidate gene association studies in neonatal sepsis to provide pooled estimates of risk for selected gene variants. Methods We performed a search using MeSH terms "infect...
journal_title:American journal of perinatology
pub_type: 杂志文章,meta分析,评审
doi:10.1055/s-0036-1597132
更新日期:2017-06-01 00:00:00
abstract::First-trimester prenatal diagnosis was offered to 104 twin pregnancies mainly for advanced maternal age and cytogenetic evaluation of a new fertilization technique. Chorionic villus sampling (CVS) was performed transcervically (35%), transabdominally (23%), or by combination of these two techniques (42%). Although no ...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-2007-994380
更新日期:1996-10-01 00:00:00
abstract::There is increasing concern about Chlamydia trachomatis infection during pregnancy, because of reports of increased maternal, fetal, and neonatal risks. Amniotic fluid is known to possess antibacterial activity and has recently been shown to inhibit formation of chlamydial inclusions in McCoy cell culture. To further ...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-2007-999341
更新日期:1991-01-01 00:00:00
abstract::This report describes 40 consecutive emergency cerclages on dilated and effaced cervices prior to 26 weeks' gestation. These "emergency" cerclages were associated with a mean extension of gestational age of 12 weeks (range, 3 days to 20.5 weeks). Thirty-one of 40 pregnancies were carried to 28 weeks' gestation and 23 ...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-2007-999307
更新日期:1992-05-01 00:00:00
abstract:OBJECTIVE:The objective of this study was to evaluate the effectiveness of vaginal progesterone in reducing adverse neonatal outcome due to preterm birth (PTB) in low-risk pregnant women with a short cervical length (CL). STUDY DESIGN:Women with a singleton pregnancy without a history of PTB underwent CL measurement a...
journal_title:American journal of perinatology
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1055/s-0035-1547327
更新日期:2015-08-01 00:00:00
abstract:OBJECTIVE:To estimate the natural history of cervical effacement in labor. STUDY DESIGN:This is a retrospective cohort study of term, vertex, singletons who reached 10 cm of cervical dilation from 2010 to 2014. Interval-censored regression was used to estimate the median number of hours between changes in effacement (...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-0038-1645858
更新日期:2019-01-01 00:00:00
abstract::Intrapartum fetal scalp sampling for platelet counts in maternal autoimmune thrombocytopenia has been advocated for determining route of delivery. We report a case in which two coagulated scalp samples were believed to indicate a normal fetal platelet count. As a result, vaginal delivery of a severely thrombocytopenic...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-2007-999401
更新日期:1991-09-01 00:00:00
abstract:OBJECTIVE:This study aims to identify risk factors for cesarean delivery (CD) surgical site infection (SSI). study design: Retrospective analysis of 2,739 CDs performed at the University of Pittsburgh in 2011. CD SSIs were defined using National Healthcare Safety Network (NHSN) criteria. Chi-square test and t-test were...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-0035-1563548
更新日期:2016-01-01 00:00:00
abstract::We sought to report an updated incidence, risk factors, and outcome of traumatic facial palsy (TFP) in newborn infants born at King Abdulaziz Medical City (KAMC), Riyadh, Saudi Arabia. We performed a 12-year retrospective study at KAMC. The records of infants with the diagnosis of TFP during the study period were revi...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-0030-1253097
更新日期:2010-10-01 00:00:00
abstract::Care of women with preterm labor has been reported by Katz et al to be enhanced by use of an electronic uterine contraction monitor. We enrolled 76 women with singleton gestations who had been successfully treated for preterm labor into a prospective randomized trial, assigning subjects in a ratio of 1:2 to a group of...
journal_title:American journal of perinatology
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1055/s-2007-999473
更新日期:1990-04-01 00:00:00
abstract:OBJECTIVE: The objective of this study was to compare national guidelines on the prevention of RhD alloimmunization. STUDY DESIGN: We performed a review of four national guidelines on prevention of alloimmunization from the American Congress of Obstetricians and Gynecologists, Royal College of Obstetricians and Gynaec...
journal_title:American journal of perinatology
pub_type: 杂志文章,评审
doi:10.1055/s-0037-1606609
更新日期:2018-01-01 00:00:00
abstract:OBJECTIVE:To develop a model to predict cesarean-associated red blood cell transfusion. STUDY DESIGN:Secondary analysis of all cesarean deliveries in the Maternal-Fetal Medicine Units Network Cesarean Registry. Using a split-sample technique, the derivation group was used to identify associated factors and build predi...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-0039-1678604
更新日期:2019-07-01 00:00:00
abstract:OBJECTIVE: This study aimed to review the feasibility of nasal high-frequency oscillatory ventilation (NHFOV) in preventing reintubation in preterm infants STUDY DESIGN: This is a retrospective cohort study of all premature newborn infants placed on NHFOV in a single-center neonatal intensive care unit. RESULTS: Twen...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-0040-1718738
更新日期:2020-10-19 00:00:00
abstract::We examined the prevalence of cesarean delivery (CD) among women with morbid obesity and extreme morbid obesity. Using Kentucky birth certificate data, a cross-sectional analysis of nulliparous singleton gestations at term was performed. We examined the prevalence of CD by body mass index (BMI; in kg/m2) using the Nat...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-0031-1280852
更新日期:2011-10-01 00:00:00
abstract::Numerous diagnostic pitfalls were noted among 6 infants with infradiaphragmatic total anomalous pulmonary venous drainage, including prolonged moderate respiratory distress in 2 infants, normal cardiac examination in 2, normal electrocardiograms in 2, arterial PO2 in excess of 100 torr in 3 cases, right radial/umbilic...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-2007-1000010
更新日期:1984-04-01 00:00:00
abstract::The incidence of triplet pregnancies has increased several times due to the widespread use of ovulation induction agents. Premature delivery is the main complication of triplet gestations. In twin conceptions it was shown definitely that elective cervical suture does not prolong these pregnancies. However, in higher o...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-2007-994691
更新日期:1993-01-01 00:00:00
abstract::The objective of this study was to perform antiphospholipid antibody screening in women with chronic hypertension to assess whether the presence of such antibodies is associated with adverse pregnancy outcome. Serum for anticardiolipin antibodies and lupus anticoagulant was obtained in pregnant women with chronic hype...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-2004-829870
更新日期:2004-07-01 00:00:00
abstract:OBJECTIVE: The objective of this study was to compare complications and mortality in neonates with hypoxic ischemic encephalopathy (HIE) on extracorporeal membrane oxygenation (ECMO) who did and did not receive therapeutic hypothermia (TH). STUDY DESIGN: The Extracorporeal Life Support Organization registry was querie...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-0037-1607197
更新日期:2018-02-01 00:00:00
abstract::Magnesium sulfate is used for seizure prophylaxis in patients with preeclampsia. It also has significant effects on calcium metabolism and could, therefore, alter the pressor response to calcium-dependent vasoconstrictors. The present in vivo rat study examined the effect of magnesium sulfate to alter the pressor resp...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-2007-999292
更新日期:1992-09-01 00:00:00
abstract::We investigated body mass index (BMI) and weight gain among pregnant women (ages 14 to 25) and assessed the relationship of BMI and weight gain on birth outcomes. We performed a secondary analysis of 841 women enrolled in a randomized controlled trial receiving prenatal care in two university-affiliated clinics. Almos...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-0028-1110088
更新日期:2009-05-01 00:00:00
abstract::This study was conducted to examine the potential effects of expanded Medicaid coverage for low income women. Statewide birth data for 1983 to 1985 were examined to determine the relationship between prenatal care and admissions to neonatal intensive care units (NICUs) and the costs of this care. An NICU sample was co...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-2007-994790
更新日期:1992-07-01 00:00:00
abstract::Objectives This study aims to examine the relationship between hospital birth volume and multiple maternal morbidities among low-risk pregnancies in rural hospitals, urban non-teaching hospitals, and urban teaching hospitals, using a representative sample of U.S. hospitals. Study Design Using the 2011 Nationwide Inpat...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-0035-1570380
更新日期:2016-05-01 00:00:00
abstract:OBJECTIVE:To determine if patients with a history of low pregnancy-associated plasma protein A (PAPP-A) in an initial pregnancy are at higher risk for adverse obstetric outcomes in a subsequent pregnancy. STUDY DESIGN:This was a retrospective cohort study in patients who underwent first trimester screening for PAPP-A ...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-0038-1673651
更新日期:2019-05-01 00:00:00
abstract:OBJECTIVE:Although neurodevelopmental outcomes related to the management of patent ductus arteriosus with intravenous indomethacin and ibuprofen are known, little data on the long-term effects of oral ibuprofen can be found in the literature. METHOD:A follow-up study of 99 infants with birth weight ≤ 1,500 g and gesta...
journal_title:American journal of perinatology
pub_type: 杂志文章,随机对照试验
doi:10.1055/s-0033-1333667
更新日期:2013-11-01 00:00:00
abstract::We present a case of a premature infant with early-onset necrotizing enterocolitis as the presenting symptom of familial dysautonomia. The diagnosis of familial dysautonomia in the neonatal period is usually rare and difficult, because many of the symptoms may be mild or nonspecific, whereas other characteristic signs...
journal_title:American journal of perinatology
pub_type: 杂志文章,评审
doi:10.1055/s-2005-871525
更新日期:2005-10-01 00:00:00
abstract::The purpose of this study was to determine if placental abruption or previa in women with a history of a prior cesarean delivery (CD) can be predicted. A retrospective cohort study of pregnant women with previous CD was conducted in 17 centers between 1996 and 2000. Women developing placenta previa or abruption in the...
journal_title:American journal of perinatology
pub_type: 杂志文章,多中心研究
doi:10.1055/s-2007-981430
更新日期:2007-05-01 00:00:00
abstract:OBJECTIVE: Semiquantitative lung ultrasound improves the timeliness of surfactant replacement, but its financial consequences are unknown. We aim to investigate if the ultrasound-guided surfactant administration influences the general costs of surfactant therapy for preterm neonates affected by respiratory distress syn...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-0040-1715821
更新日期:2020-08-20 00:00:00
abstract::The pregnant woman with idiopathic thrombocytopenic purpura (ITP) and her fetus-neonate present a number of challenging issues for both the perinatologist and neonatologist. A review of these issues within a single format is helpful because of the widely scattered nature of the pertinent information in the medical lit...
journal_title:American journal of perinatology
pub_type: 杂志文章,评审
doi:10.1055/s-2007-1000014
更新日期:1984-04-01 00:00:00
abstract::Major akinesia with arthrogryposis and craniosynostosis at birth mimics irreversible disorders of the nervous system of pejorative outcome. In this context, the early detection of anti-acetylcholine fetal receptor antibodies in the mother may allow rapid diagnosis of transient neonatal myasthenia of favorable prognosi...
journal_title:American journal of perinatology
pub_type: 杂志文章
doi:10.1055/s-2002-34468
更新日期:2002-08-01 00:00:00